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    Clinical Trial Results:
    A Multicenter, Randomized, Double-blind, Parallel Group, Placebo controlled, Phase IIb Efficacy and Safety Study of Adjunctive AZD6765 in Patients with Major Depressive Disorder (MDD) and a History of Inadequate Response to Antidepressants

    Summary
    EudraCT number
    2011-004690-87
    Trial protocol
    SK  
    Global end of trial date
    09 Oct 2013

    Results information
    Results version number
    v1(current)
    This version publication date
    27 May 2017
    First version publication date
    27 May 2017
    Other versions
    Summary report(s)
    NS/D6702C00031-CSR Synopsis

    Trial information

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    Trial identification
    Sponsor protocol code
    D6702C00031
    Additional study identifiers
    ISRCTN number
    -
    US NCT number
    -
    WHO universal trial number (UTN)
    -
    Sponsors
    Sponsor organisation name
    AstraZeneca
    Sponsor organisation address
    Pepparedsleden 1, Mölndal, Sweden, SE-431 83
    Public contact
    Sanjeev Pathak, AstraZeneca, ClinicalTrialTransparency@astrazeneca.com
    Scientific contact
    Sanjeev Pathak, AstraZeneca, ClinicalTrialTransparency@astrazeneca.com
    Paediatric regulatory details
    Is trial part of an agreed paediatric investigation plan (PIP)
    No
    Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Results analysis stage
    Analysis stage
    Final
    Date of interim/final analysis
    09 Oct 2013
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    26 Aug 2013
    Global end of trial reached?
    Yes
    Global end of trial date
    09 Oct 2013
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To evaluate the efficacy of AZD6765 (50 mg or 100 mg/infusion) as adjunct to current antidepressant medication versus antidepressant medication + placebo as assessed by the change from baseline to Week 6 in the MADRS total score in patients with MDD (DSM IV TR 296.2x or 296.3x) who exhibited an inadequate response to 3 or more different antidepressant treatments by history. Inadequate response was defined as persistent symptoms that, as judged by the investigator, continue to meet the diagnostic criteria for a Major Depressive Episode (MDE) according to the DSM IV TR.
    Protection of trial subjects
    Treated in routine care.
    Background therapy
    At least 1 antidepressant medication for a minimum of 6 weeks prior to randomization.
    Evidence for comparator
    -
    Actual start date of recruitment
    16 Dec 2011
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    No
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Chile: 20
    Country: Number of subjects enrolled
    Slovakia: 27
    Country: Number of subjects enrolled
    South Africa: 17
    Country: Number of subjects enrolled
    United States: 238
    Worldwide total number of subjects
    302
    EEA total number of subjects
    27
    Number of subjects enrolled per age group
    In utero
    0
    Preterm newborn - gestational age < 37 wk
    0
    Newborns (0-27 days)
    0
    Infants and toddlers (28 days-23 months)
    0
    Children (2-11 years)
    0
    Adolescents (12-17 years)
    0
    Adults (18-64 years)
    287
    From 65 to 84 years
    15
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    This multicenter study was conducted in Chile, Slovakia, South Africa, and the United States between 16 December 2011 and 26 August 2013. A total of 542 patients were enrolled in the study and of these, 302 patients were randomized to treatment. 240 patients were not randomized to treatment due to eligibility criteria not being fulfilled.

    Pre-assignment
    Screening details
    The study had a screening/washout period of up to 42 days, a 12-week double blind treatment period, and a 14-day follow-up period. Patients received 3 infusions per week during Weeks 1 to 3,1 infusion per week during Weeks 4 to 6, and 1 infusion every other week during Weeks 7 to 12.

    Period 1
    Period 1 title
    Overall Study (overall period)
    Is this the baseline period?
    Yes
    Allocation method
    Randomised - controlled
    Blinding used
    Double blind
    Roles blinded
    Investigator, Monitor, Subject, Carer, Data analyst, Assessor

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    AZD6765 50 mg
    Arm description
    Intravenous infusion
    Arm type
    Experimental

    Investigational medicinal product name
    AZD6765
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Solution for Infusion, 0.5 mg/mL

    Arm title
    AZD6765 100 mg
    Arm description
    Intravenous infusion
    Arm type
    Experimental

    Investigational medicinal product name
    AZD6765
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Solution for Infusion, 1.0 mg/mL

    Arm title
    Placebo
    Arm description
    Intravenous infusion
    Arm type
    Placebo

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Solution for Infusion, 0.9% saline

    Number of subjects in period 1
    AZD6765 50 mg AZD6765 100 mg Placebo
    Started
    101
    101
    100
    Completed
    80
    81
    77
    Not completed
    21
    20
    23
         Condition under Investigation Worsened
             3
             2
             4
         Physician decision
             -
             1
             -
         Study-Specific Withdrawal Criteria
             2
             -
             1
         Lack of efficacy
             1
             -
             1
         Adverse event, non-fatal
             1
             7
             3
         Incorrect randomization
             -
             1
             -
         Consent withdrawn by subject
             10
             7
             12
         Severe Non-Compliance to Protocol
             1
             -
             1
         Lost to follow-up
             3
             2
             1

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    AZD6765 50 mg
    Reporting group description
    Intravenous infusion

    Reporting group title
    AZD6765 100 mg
    Reporting group description
    Intravenous infusion

    Reporting group title
    Placebo
    Reporting group description
    Intravenous infusion

    Reporting group values
    AZD6765 50 mg AZD6765 100 mg Placebo Total
    Number of subjects
    101 101 100 302
    Age categorical
    Units: Subjects
        Adults (18-39 years)
    24 22 19 65
        Adults (40-64 years)
    74 74 74 222
        65 years and over
    3 5 7 15
    Age Continuous
    Units: Years
        arithmetic mean (standard deviation)
    47.7 ± 11.19 47.5 ± 11.89 49.5 ± 11.12 -
    Gender, Male/Female
    Units: Subjects
        Female
    62 70 65 197
        Male
    39 31 35 105
    Race/Ethnicity, Customized
    Units: Subjects
        White
    91 87 91 269
        Black or African American
    8 11 6 25
        Asian
    0 3 1 4
        Other
    2 0 2 4

    End points

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    End points reporting groups
    Reporting group title
    AZD6765 50 mg
    Reporting group description
    Intravenous infusion

    Reporting group title
    AZD6765 100 mg
    Reporting group description
    Intravenous infusion

    Reporting group title
    Placebo
    Reporting group description
    Intravenous infusion

    Primary: Change from baseline to Week 6 in the Montgomery-Asberg Depression Rating Scale (MADRS) total score

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    End point title
    Change from baseline to Week 6 in the Montgomery-Asberg Depression Rating Scale (MADRS) total score
    End point description
    A 10-item scale for the evaluation of depressive symptoms. Each MADRS item is rated on a 0 to 6 scale. The MADRS total score is calculated as the sum of the 10 individual item scores; the total score can range from 0 to 60. Higher MADRS scores indicate higher levels of depressive symptoms.
    End point type
    Primary
    End point timeframe
    Baseline to Week 6
    End point values
    AZD6765 50 mg AZD6765 100 mg Placebo
    Number of subjects analysed
    101
    100
    97
    Units: units on a scale
        least squares mean (standard error)
    -14.37 ± 1.238
    -14.4 ± 1.244
    -13.18 ± 1.266
    Statistical analysis title
    Change in MADRS total score - baseline to Week 6
    Statistical analysis description
    Mixed model repeated measures (MMRM) includes treatment, pooled center, visit, treatment by visit interaction, and baseline MADRS score by visit interaction as explanatory variables. Treatment, visit, treatment by visit interaction, and baseline MADRS score by visit interaction are fixed effects in the model; pooled center is a random effect.
    Comparison groups
    Placebo v AZD6765 50 mg
    Number of subjects included in analysis
    198
    Analysis specification
    Pre-specified
    Analysis type
    P-value
    = 0.63 [1]
    Method
    Mixed models for repeated measures
    Parameter type
    LS mean difference
    Point estimate
    -1.18
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -4.519
         upper limit
    2.152
    Variability estimate
    Standard error of the mean
    Dispersion value
    1.695
    Notes
    [1] - The adjusted p-values protect the overall family-wise error rate across the 6 key comparisons of AZD6765 100 mg and 50 mg to placebo (for MADRS change from baseline to 6 weeks and to 12 weeks and for Sustained Response).
    Statistical analysis title
    Change in MADRS total score - baseline to Week 6
    Statistical analysis description
    MMRM includes treatment, pooled center, visit, treatment by visit interaction, and baseline MADRS score by visit interaction as explanatory variables. Treatment, visit, treatment by visit interaction, and baseline MADRS score by visit interaction are fixed effects in the model; pooled center is a random effect.
    Comparison groups
    AZD6765 100 mg v Placebo
    Number of subjects included in analysis
    197
    Analysis specification
    Pre-specified
    Analysis type
    P-value
    = 0.476 [2]
    Method
    Mixed models for repeated measures
    Parameter type
    LS mean difference
    Point estimate
    -1.21
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -4.563
         upper limit
    2.134
    Variability estimate
    Standard error of the mean
    Dispersion value
    1.701
    Notes
    [2] - The adjusted p-values protect the overall family-wise error rate across the 6 key comparisons of AZD6765 100 mg and 50 mg to placebo (for MADRS change from baseline to 6 weeks and to 12 weeks and for Sustained Response).

    Secondary: Change from baseline to Week 12 in the Montgomery-Asberg Depression Rating Scale (MADRS) total score

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    End point title
    Change from baseline to Week 12 in the Montgomery-Asberg Depression Rating Scale (MADRS) total score
    End point description
    A 10-item scale for the evaluation of depressive symptoms. Each MADRS item is rated on a 0 to 6 scale. The MADRS total score is calculated as the sum of the 10 individual item scores; the total score can range from 0 to 60. Higher MADRS scores indicate higher levels of depressive symptoms.
    End point type
    Secondary
    End point timeframe
    Baseline to Week 12
    End point values
    AZD6765 50 mg AZD6765 100 mg Placebo
    Number of subjects analysed
    101
    100
    97
    Units: units on a scale
        least squares mean (standard error)
    -15.97 ± 1.313
    -13.03 ± 1.332
    -13.92 ± 1.354
    Statistical analysis title
    Change in MADRS total score - baseline to Week 12
    Statistical analysis description
    Mixed model repeated measures (MMRM) includes treatment, pooled center, visit, treatment by visit interaction, and baseline MADRS score by visit interaction as explanatory variables. Treatment, visit, treatment by visit interaction, and baseline MADRS score by visit interaction are fixed effects in the model; pooled center is a random effect.
    Comparison groups
    AZD6765 50 mg v Placebo
    Number of subjects included in analysis
    198
    Analysis specification
    Pre-specified
    Analysis type
    P-value
    = 0.63 [3]
    Method
    Mixed models for repeated measures
    Parameter type
    LS mean difference
    Point estimate
    -2.05
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -5.628
         upper limit
    1.522
    Variability estimate
    Standard error of the mean
    Dispersion value
    1.816
    Notes
    [3] - The adjusted p-values protect the overall family-wise error rate across the 6 key comparisons of AZD6765 100 mg and 50 mg to placebo (for MADRS change from baseline to 6 weeks and to 12 weeks and for Sustained Response).
    Statistical analysis title
    Change in MADRS total score - baseline to Week 12
    Statistical analysis description
    MMRM includes treatment, pooled center, visit, treatment by visit interaction, and baseline MADRS score by visit interaction as explanatory variables. Treatment, visit, treatment by visit interaction, and baseline MADRS score by visit interaction are fixed effects in the model; pooled center is a random effect.
    Comparison groups
    AZD6765 100 mg v Placebo
    Number of subjects included in analysis
    197
    Analysis specification
    Pre-specified
    Analysis type
    P-value
    = 0.63 [4]
    Method
    Mixed models for repeated measures
    Parameter type
    LS mean difference
    Point estimate
    0.88
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -2.72
         upper limit
    4.485
    Variability estimate
    Standard error of the mean
    Dispersion value
    1.83
    Notes
    [4] - The adjusted p-values protect the overall family-wise error rate across the 6 key comparisons of AZD6765 100 mg and 50 mg to placebo (for MADRS change from baseline to 6 weeks and to 12 weeks and for Sustained Response).

    Secondary: Percentage of patients with Sustained Response from Week 6 to Week 12 (defined as ≥50% reduction from baseline in the MADRS total score at Week 6 and which is maintained through Week 12)

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    End point title
    Percentage of patients with Sustained Response from Week 6 to Week 12 (defined as ≥50% reduction from baseline in the MADRS total score at Week 6 and which is maintained through Week 12)
    End point description
    The percentage of patients with with Sustained Response (defined as ≥50% reduction from baseline in the MADRS total score at Week 6 and which is maintained through Week 12) was calculated.
    End point type
    Secondary
    End point timeframe
    Week 6 to Week 12
    End point values
    AZD6765 50 mg AZD6765 100 mg Placebo
    Number of subjects analysed
    101
    100
    97
    Units: percentage of participants analyzed
        number (not applicable)
    22.8
    23
    21.6
    Statistical analysis title
    Sustained MADRS Response - Week 6 to Week 12
    Statistical analysis description
    Logistic regression model including treatment as a fixed effect and the baseline MADRS total score as a covariate.
    Comparison groups
    AZD6765 50 mg v Placebo
    Number of subjects included in analysis
    198
    Analysis specification
    Pre-specified
    Analysis type
    P-value
    = 0.852 [5]
    Method
    Regression, Logistic
    Parameter type
    Odds ratio (OR)
    Point estimate
    1.07
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    0.544
         upper limit
    2.089
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.366
    Notes
    [5] - The adjusted p-values protect the overall family-wise error rate across the 6 key comparisons of AZD6765 100 mg and 50 mg to placebo (for MADRS change from baseline to 6 weeks and to 12 weeks and for Sustained Response).
    Statistical analysis title
    Sustained MADRS Response - Week 6 to Week 12
    Statistical analysis description
    Logistic regression model including treatment as a fixed effect and the baseline MADRS total score as a covariate.
    Comparison groups
    AZD6765 100 mg v Placebo
    Number of subjects included in analysis
    197
    Analysis specification
    Pre-specified
    Analysis type
    P-value
    = 0.821 [6]
    Method
    Regression, Logistic
    Parameter type
    Odds ratio (OR)
    Point estimate
    1.08
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    0.552
         upper limit
    2.115
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.37
    Notes
    [6] - The adjusted p-values protect the overall family-wise error rate across the 6 key comparisons of AZD6765 100 mg and 50 mg to placebo (for MADRS change from baseline to 6 weeks and to 12 weeks and for Sustained Response).

    Secondary: Percentage of patients who were Responders (defined as a ≥50% reduction from baseline in MADRS total score) at Week 6

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    End point title
    Percentage of patients who were Responders (defined as a ≥50% reduction from baseline in MADRS total score) at Week 6
    End point description
    The percentage of patients who were Responders (defined as ≥50% reduction from baseline in MADRS total score) was calculated.
    End point type
    Secondary
    End point timeframe
    Baseline to Week 6
    End point values
    AZD6765 50 mg AZD6765 100 mg Placebo
    Number of subjects analysed
    86
    84
    82
    Units: percentage of participants analyzed
        number (not applicable)
    36
    44
    39
    Statistical analysis title
    Adjusted odds ratio of Response at Week 6
    Statistical analysis description
    Generalized linear model of the repeated measures (GEE) with logic link including treatment, visit, and treatment by visit interaction as fixed effects and the baseline MADRS total score as a covariate.
    Comparison groups
    AZD6765 50 mg v Placebo
    Number of subjects included in analysis
    168
    Analysis specification
    Pre-specified
    Analysis type
    P-value
    = 0.751
    Method
    GEE for repeated measures
    Parameter type
    Odds ratio (OR)
    Point estimate
    0.9
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    0.485
         upper limit
    1.686
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.318
    Statistical analysis title
    Adjusted odds ratio of Response at Week 6
    Statistical analysis description
    Generalized linear model of the repeated measures (GEE) with logic link including treatment, visit, and treatment by visit interaction as fixed effects and the baseline MADRS total score as a covariate.
    Comparison groups
    AZD6765 100 mg v Placebo
    Number of subjects included in analysis
    166
    Analysis specification
    Pre-specified
    Analysis type
    P-value
    = 0.555
    Method
    GEE for repeated measures
    Parameter type
    Odds ratio (OR)
    Point estimate
    1.2
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    0.65
         upper limit
    2.233
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.315

    Secondary: Percentage of patients who were Responders (defined as a ≥50% reduction from baseline in MADRS total score) at Week 12

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    End point title
    Percentage of patients who were Responders (defined as a ≥50% reduction from baseline in MADRS total score) at Week 12
    End point description
    The percentage of patients who were Responders (defined as ≥50% reduction from baseline in MADRS total score) was calculated.
    End point type
    Secondary
    End point timeframe
    Baseline to Week 12
    End point values
    AZD6765 50 mg AZD6765 100 mg Placebo
    Number of subjects analysed
    89
    85
    81
    Units: percentage of participants analyzed
        number (not applicable)
    48.3
    36.5
    40.7
    Statistical analysis title
    Adjusted odds ratio of Response at Week 12
    Statistical analysis description
    Generalized linear model of the repeated measures (GEE) with logic link including treatment, visit, and treatment by visit interaction as fixed effects and the baseline MADRS total score as a covariate.
    Comparison groups
    AZD6765 50 mg v Placebo
    Number of subjects included in analysis
    170
    Analysis specification
    Pre-specified
    Analysis type
    P-value
    = 0.434
    Method
    GEE for repeated measures
    Parameter type
    Odds ratio (OR)
    Point estimate
    1.27
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    0.699
         upper limit
    2.301
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.304
    Statistical analysis title
    Adjusted odds ratio of Response at Week 12
    Statistical analysis description
    Generalized linear model of the repeated measures (GEE) with logic link including treatment, visit, and treatment by visit interaction as fixed effects and the baseline MADRS total score as a covariate.
    Comparison groups
    AZD6765 100 mg v Placebo
    Number of subjects included in analysis
    166
    Analysis specification
    Pre-specified
    Analysis type
    P-value
    = 0.286
    Method
    GEE for repeated measures
    Parameter type
    Odds ratio (OR)
    Point estimate
    0.71
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    0.377
         upper limit
    1.334
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.322

    Secondary: Percentage of patients who were Remitted (defined as MADRS total score ≤10) at Week 6

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    End point title
    Percentage of patients who were Remitted (defined as MADRS total score ≤10) at Week 6
    End point description
    The percentage of patients who were Remitted (defined as MADRS total score ≤10) was calculated.
    End point type
    Secondary
    End point timeframe
    Baseline to Week 6
    End point values
    AZD6765 50 mg AZD6765 100 mg Placebo
    Number of subjects analysed
    86
    84
    82
    Units: percentage of participants analyzed
        number (not applicable)
    23.3
    23.8
    18.3
    Statistical analysis title
    Adjusted odds ratio of Remission at Week 6
    Statistical analysis description
    Generalized linear model of the repeated measures (GEE) with logic link including treatment, visit, and treatment by visit interaction as fixed effects and the baseline MADRS total score as a covariate.
    Comparison groups
    AZD6765 50 mg v Placebo
    Number of subjects included in analysis
    168
    Analysis specification
    Pre-specified
    Analysis type
    P-value
    = 0.357
    Method
    GEE for repeated measures
    Parameter type
    Odds ratio (OR)
    Point estimate
    1.42
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    0.672
         upper limit
    3.007
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.382
    Statistical analysis title
    Adjusted odds ratio of Remission at Week 6
    Statistical analysis description
    Generalized linear model of the repeated measures (GEE) with logic link including treatment, visit, and treatment by visit interaction as fixed effects and the baseline MADRS total score as a covariate.
    Comparison groups
    AZD6765 100 mg v Placebo
    Number of subjects included in analysis
    166
    Analysis specification
    Pre-specified
    Analysis type
    P-value
    = 0.463
    Method
    GEE for repeated measures
    Parameter type
    Odds ratio (OR)
    Point estimate
    1.33
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    0.622
         upper limit
    2.84
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.387

    Secondary: Percentage of patients who were Remitted (defined as MADRS total score ≤10) at Week 12

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    End point title
    Percentage of patients who were Remitted (defined as MADRS total score ≤10) at Week 12
    End point description
    The percentage of patients who were Remitted (defined as MADRS total score ≤10) was calculated.
    End point type
    Secondary
    End point timeframe
    Baseline to Week 12
    End point values
    AZD6765 50 mg AZD6765 100 mg Placebo
    Number of subjects analysed
    89
    85
    81
    Units: percentage of participants analyzed
        number (not applicable)
    27
    22.4
    25.9
    Statistical analysis title
    Adjusted odds ratio of Remission at Week 12
    Statistical analysis description
    Generalized linear model of the repeated measures (GEE) with logic link including treatment, visit, and treatment by visit interaction as fixed effects and the baseline MADRS total score as a covariate.
    Comparison groups
    AZD6765 50 mg v Placebo
    Number of subjects included in analysis
    170
    Analysis specification
    Pre-specified
    Analysis type
    P-value
    = 0.911
    Method
    GEE for repeated measures
    Parameter type
    Odds ratio (OR)
    Point estimate
    1.04
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    0.532
         upper limit
    2.031
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.342
    Statistical analysis title
    Adjusted odds ratio of Remission at Week 12
    Statistical analysis description
    Generalized linear model of the repeated measures (GEE) with logic link including treatment, visit, and treatment by visit interaction as fixed effects and the baseline MADRS total score as a covariate.
    Comparison groups
    AZD6765 100 mg v Placebo
    Number of subjects included in analysis
    166
    Analysis specification
    Pre-specified
    Analysis type
    P-value
    = 0.509
    Method
    GEE for repeated measures
    Parameter type
    Odds ratio (OR)
    Point estimate
    0.78
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    0.382
         upper limit
    1.613
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.368

    Secondary: Change from baseline in functional impairment as measured by the change from baseline in the Sheehan Disability Scale (SDS) total score

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    End point title
    Change from baseline in functional impairment as measured by the change from baseline in the Sheehan Disability Scale (SDS) total score
    End point description
    A 3-item, self-administered scale that measures the extent a patient is impaired by their disease. Higher scores indicate more severe impairment. The SDS total score is calculated as the sum of the score for the 3 intercorrelated domains (school/work, social life, and family life/home responsibilities), ranges from 0 (no impairment) to 30 (most severe impairment).
    End point type
    Secondary
    End point timeframe
    Baseline to Week 12
    End point values
    AZD6765 50 mg AZD6765 100 mg Placebo
    Number of subjects analysed
    101
    100
    97
    Units: units on a scale
    least squares mean (standard error)
        Week 6
    -7.08 ± 0.959
    -6.9 ± 0.981
    -6.91 ± 0.989
        Week 12
    -6.98 ± 0.995
    -6.8 ± 1.021
    -8.09 ± 1.034
    Statistical analysis title
    Change in SDS total score - baseline to Week 6
    Statistical analysis description
    MMRM includes treatment, pooled center, visit, treatment by visit interaction, and baseline SDS score by visit interaction as explanatory variables. Treatment, visit, treatment by visit interaction, and baseline SDS score by visit interaction are fixed effects in the model; pooled center is a random effect.
    Comparison groups
    AZD6765 50 mg v Placebo
    Number of subjects included in analysis
    198
    Analysis specification
    Pre-specified
    Analysis type
    P-value
    = 0.889 [7]
    Method
    Mixed models for repeated measures
    Parameter type
    LS mean difference
    Point estimate
    -0.17
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -2.609
         upper limit
    2.264
    Variability estimate
    Standard error of the mean
    Dispersion value
    1.238
    Notes
    [7] - Analysis for change in SDS total score from baseline to Week 6
    Statistical analysis title
    Change in SDS total score - baseline to Week 6
    Statistical analysis description
    MMRM includes treatment, pooled center, visit, treatment by visit interaction, and baseline SDS score by visit interaction as explanatory variables. Treatment, visit, treatment by visit interaction, and baseline SDS score by visit interaction are fixed effects in the model; pooled center is a random effect.
    Comparison groups
    AZD6765 100 mg v Placebo
    Number of subjects included in analysis
    197
    Analysis specification
    Pre-specified
    Analysis type
    P-value
    = 0.992 [8]
    Method
    Mixed models for repeated measures
    Parameter type
    LS mean difference
    Point estimate
    0.01
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -2.477
         upper limit
    2.501
    Variability estimate
    Standard error of the mean
    Dispersion value
    1.264
    Notes
    [8] - Analysis for change in SDS total score from baseline to Week 6
    Statistical analysis title
    Change in SDS total score - baseline to Week 12
    Statistical analysis description
    MMRM includes treatment, pooled center, visit, treatment by visit interaction, and baseline SDS score by visit interaction as explanatory variables. Treatment, visit, treatment by visit interaction, and baseline SDS score by visit interaction are fixed effects in the model; pooled center is a random effect.
    Comparison groups
    AZD6765 50 mg v Placebo
    Number of subjects included in analysis
    198
    Analysis specification
    Pre-specified
    Analysis type
    P-value
    = 0.392 [9]
    Method
    Mixed models for repeated measures
    Parameter type
    LS mean difference
    Point estimate
    1.11
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -1.448
         upper limit
    3.678
    Variability estimate
    Standard error of the mean
    Dispersion value
    1.301
    Notes
    [9] - Analysis for change in SDS total score from baseline to Week 12
    Statistical analysis title
    Change in SDS total score - baseline to Week 12
    Statistical analysis description
    MMRM includes treatment, pooled center, visit, treatment by visit interaction, and baseline SDS score by visit interaction as explanatory variables. Treatment, visit, treatment by visit interaction, and baseline SDS score by visit interaction are fixed effects in the model; pooled center is a random effect.
    Comparison groups
    AZD6765 100 mg v Placebo
    Number of subjects included in analysis
    197
    Analysis specification
    Pre-specified
    Analysis type
    P-value
    = 0.333 [10]
    Method
    Mixed models for repeated measures
    Parameter type
    LS mean difference
    Point estimate
    1.29
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -1.327
         upper limit
    3.908
    Variability estimate
    Standard error of the mean
    Dispersion value
    1.329
    Notes
    [10] - Analysis for changed in SDS total score from baseline to Week 12

    Secondary: Change in severity of depressive symptoms as measured by change from baseline in the Clinical Global Impression-Severity (CGI-S) score

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    End point title
    Change in severity of depressive symptoms as measured by change from baseline in the Clinical Global Impression-Severity (CGI-S) score
    End point description
    Clinical Global Impression - Severity (CGI-S) scale rates the severity of the patient’s illness at the time of assessment, range from 1 (normal, not ill) to 7 (very severely ill).
    End point type
    Secondary
    End point timeframe
    Baseline to Week 12
    End point values
    AZD6765 50 mg AZD6765 100 mg Placebo
    Number of subjects analysed
    101
    100
    97
    Units: units on a scale
    least squares mean (standard error)
        Week 6
    -1.5 ± 0.16
    -1.5 ± 0.16
    -1.4 ± 0.16
        Week 12
    -1.8 ± 0.16
    -1.5 ± 0.16
    -1.6 ± 0.16
    Statistical analysis title
    Change in CGI-S score - baseline to Week 6
    Statistical analysis description
    MMRM includes treatment, pooled center, visit, treatment by visit interaction, and baseline CGI-S score by visit interaction as explanatory variables. Treatment, visit, treatment by visit interaction, and baseline CGI-S score by visit interaction are fixed effects in the model; pooled center is a random effect.
    Comparison groups
    AZD6765 50 mg v Placebo
    Number of subjects included in analysis
    198
    Analysis specification
    Pre-specified
    Analysis type
    P-value
    = 0.728 [11]
    Method
    Mixed models for repeated measures
    Parameter type
    LS mean difference
    Point estimate
    -0.1
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -0.49
         upper limit
    0.34
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.21
    Notes
    [11] - Analysis for change in CGI-S total score from baseline to Week 6
    Statistical analysis title
    Change in CGI-S score - baseline to Week 6
    Statistical analysis description
    MMRM includes treatment, pooled center, visit, treatment by visit interaction, and baseline CGI-S score by visit interaction as explanatory variables. Treatment, visit, treatment by visit interaction, and baseline CGI-S score by visit interaction are fixed effects in the model; pooled center is a random effect.
    Comparison groups
    AZD6765 100 mg v Placebo
    Number of subjects included in analysis
    197
    Analysis specification
    Pre-specified
    Analysis type
    P-value
    = 0.562 [12]
    Method
    Mixed models for repeated measures
    Parameter type
    LS mean difference
    Point estimate
    -0.1
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -0.54
         upper limit
    0.29
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.21
    Notes
    [12] - Analysis for change in CGI-S total score from baseline to Week 6
    Statistical analysis title
    Change in CGI-S score - baseline to Week 12
    Statistical analysis description
    MMRM includes treatment, pooled center, visit, treatment by visit interaction, and baseline CGI-S score by visit interaction as explanatory variables. Treatment, visit, treatment by visit interaction, and baseline CGI-S score by visit interaction are fixed effects in the model; pooled center is a random effect.
    Comparison groups
    AZD6765 50 mg v Placebo
    Number of subjects included in analysis
    198
    Analysis specification
    Pre-specified
    Analysis type
    P-value
    = 0.283 [13]
    Method
    Mixed models for repeated measures
    Parameter type
    LS mean difference
    Point estimate
    -0.2
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -0.64
         upper limit
    0.19
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.21
    Notes
    [13] - Analysis for change in CGI-S total score from baseline to Week 12
    Statistical analysis title
    Change in CGI-S score - baseline to Week 12
    Statistical analysis description
    MMRM includes treatment, pooled center, visit, treatment by visit interaction, and baseline CGI-S score by visit interaction as explanatory variables. Treatment, visit, treatment by visit interaction, and baseline CGI-S score by visit interaction are fixed effects in the model; pooled center is a random effect.
    Comparison groups
    AZD6765 100 mg v Placebo
    Number of subjects included in analysis
    197
    Analysis specification
    Pre-specified
    Analysis type
    P-value
    = 0.54 [14]
    Method
    Mixed models for repeated measures
    Parameter type
    LS mean difference
    Point estimate
    0.1
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -0.29
         upper limit
    0.55
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.21
    Notes
    [14] - Analysis for changed in CGI-S total score from baseline to Week 12

    Secondary: Change in severity of depressive symptoms as measured by the CGI-I response (defined as CGI-I rating of “very much improved” or “much improved”) at Week 6

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    End point title
    Change in severity of depressive symptoms as measured by the CGI-I response (defined as CGI-I rating of “very much improved” or “much improved”) at Week 6
    End point description
    A 3-part, clinician-administered scale that rates the improvement or worsening of the patient's illness from randomization (baseline). Each item is scored on a 1 to 7 scale. CGI-I scores >4 indicate worsening, while scores <4 indicate improvement.
    End point type
    Secondary
    End point timeframe
    Baseline to Week 6
    End point values
    AZD6765 50 mg AZD6765 100 mg Placebo
    Number of subjects analysed
    86
    84
    82
    Units: percentage of participants analyzed
        number (not applicable)
    51.2
    47.6
    37.8
    Statistical analysis title
    Response in CGI-I - baseline to Week 6
    Statistical analysis description
    Generalized linear model of the repeated measures (GEE) with logic link including treatment, visit, and treatment by visit interaction as fixed effects and the baseline CGI-S total score as a covariate.
    Comparison groups
    AZD6765 50 mg v Placebo
    Number of subjects included in analysis
    168
    Analysis specification
    Pre-specified
    Analysis type
    P-value
    = 0.067
    Method
    GEE for repeated measures
    Parameter type
    Odds ratio (OR)
    Point estimate
    1.74
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    0.962
         upper limit
    3.141
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.302
    Statistical analysis title
    Response in CGI-I - baseline to Week 6
    Statistical analysis description
    Generalized linear model of the repeated measures (GEE) with logic link including treatment, visit, and treatment by visit interaction as fixed effects and the baseline CGI-S total score as a covariate.
    Comparison groups
    AZD6765 100 mg v Placebo
    Number of subjects included in analysis
    166
    Analysis specification
    Pre-specified
    Analysis type
    P-value
    = 0.23
    Method
    GEE for repeated measures
    Parameter type
    Odds ratio (OR)
    Point estimate
    1.43
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    0.798
         upper limit
    2.558
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.297

    Secondary: Change in severity of depressive symptoms as measured by the CGI-I response (defined as CGI-I rating of “very much improved” or “much improved”) at Week 12

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    End point title
    Change in severity of depressive symptoms as measured by the CGI-I response (defined as CGI-I rating of “very much improved” or “much improved”) at Week 12
    End point description
    A 3-part, clinician-administered scale that rates the improvement or worsening of the patient's illness from randomization (baseline). Each item is scored on a 1 to 7 scale. CGI-I scores >4 indicate worsening, while scores <4 indicate improvement.
    End point type
    Secondary
    End point timeframe
    Baseline to Week 12
    End point values
    AZD6765 50 mg AZD6765 100 mg Placebo
    Number of subjects analysed
    89
    85
    81
    Units: percentage of participants analyzed
        number (not applicable)
    50.6
    44.7
    40.7
    Statistical analysis title
    Response in CGI-I - baseline to Week 12
    Statistical analysis description
    Generalized linear model of the repeated measures (GEE) with logic link including treatment, visit, and treatment by visit interaction as fixed effects and the baseline CGI-S total score as a covariate.
    Comparison groups
    AZD6765 50 mg v Placebo
    Number of subjects included in analysis
    170
    Analysis specification
    Pre-specified
    Analysis type
    P-value
    = 0.268
    Method
    GEE for repeated measures
    Parameter type
    Odds ratio (OR)
    Point estimate
    1.38
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    0.78
         upper limit
    2.447
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.292
    Statistical analysis title
    Response in CGI-I - baseline to Week 12
    Statistical analysis description
    Generalized linear model of the repeated measures (GEE) with logic link including treatment, visit, and treatment by visit interaction as fixed effects and the baseline CGI-S total score as a covariate.
    Comparison groups
    AZD6765 100 mg v Placebo
    Number of subjects included in analysis
    166
    Analysis specification
    Pre-specified
    Analysis type
    P-value
    = 0.909
    Method
    GEE for repeated measures
    Parameter type
    Odds ratio (OR)
    Point estimate
    0.97
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    0.533
         upper limit
    1.75
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.303

    Secondary: Change from baseline in self-rated severity of depressive symptoms as measured by Quick Inventory of Depressive Symptomatology Self-Rated 16-item scale (QIDS-SR-16) total score

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    End point title
    Change from baseline in self-rated severity of depressive symptoms as measured by Quick Inventory of Depressive Symptomatology Self-Rated 16-item scale (QIDS-SR-16) total score
    End point description
    A 16-question self-report inventory that includes the 9 Diagnostic and Statistical Manual of Mental Disorders, 4th Edition, Text Revision (DSM-IV-TR) criteria symptom domains: sad mood, concentration, self-outlook, suicidal ideation, involvement, energy/fatigability, sleep disturbance (4 items: initial, middle, late insomnia, and hypersomnia), appetite/weight increased or decrease (4 items), and psychomotor agitation/retardation (2 items). The QIDS-SR-16 total scores range from 0 (least severe) to 27 (most severe).
    End point type
    Secondary
    End point timeframe
    Baseline to Week 12
    End point values
    AZD6765 50 mg AZD6765 100 mg Placebo
    Number of subjects analysed
    101
    100
    97
    Units: units on a scale
    least squares mean (standard error)
        Week 6
    -8.7 ± 0.69
    -7.9 ± 0.7
    -8.1 ± 0.71
        Week 12
    -9.2 ± 0.7
    -7.6 ± 0.71
    -8.9 ± 0.72
    Statistical analysis title
    Change in QIDS-SR-16 score - baseline to Week 6
    Statistical analysis description
    MMRM includes treatment, pooled center, visit, treatment by visit interaction, and baseline QIDS-SR-16 total score by visit interaction as explanatory variables. Treatment, visit, treatment by visit interaction, and baseline QIDS-SR-16 total score by visit interaction are fixed effects in the model; pooled center is a random effect.
    Comparison groups
    AZD6765 50 mg v Placebo
    Number of subjects included in analysis
    198
    Analysis specification
    Pre-specified
    Analysis type
    P-value
    = 0.505 [15]
    Method
    Mixed models for repeated measures
    Parameter type
    LS mean difference
    Point estimate
    -0.6
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -2.29
         upper limit
    1.13
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.87
    Notes
    [15] - Analysis for change in QIDS-SR-16 total score from baseline to Week 6
    Statistical analysis title
    Change in QIDS-SR-16 score - baseline to Week 6
    Statistical analysis description
    MMRM includes treatment, pooled center, visit, treatment by visit interaction, and baseline QIDS-SR-16 total score by visit interaction as explanatory variables. Treatment, visit, treatment by visit interaction, and baseline QIDS-SR-16 total score by visit interaction are fixed effects in the model; pooled center is a random effect.
    Comparison groups
    AZD6765 100 mg v Placebo
    Number of subjects included in analysis
    197
    Analysis specification
    Pre-specified
    Analysis type
    P-value
    = 0.842 [16]
    Method
    Mixed models for repeated measures
    Parameter type
    LS mean difference
    Point estimate
    0.2
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -1.56
         upper limit
    1.91
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.88
    Notes
    [16] - Analysis for change in QIDS-SR-16 total score from baseline to Week 6
    Statistical analysis title
    Change in QIDS-SR-16 score - baseline to Week 12
    Statistical analysis description
    MMRM includes treatment, pooled center, visit, treatment by visit interaction, and baseline QIDS-SR-16 total score by visit interaction as explanatory variables. Treatment, visit, treatment by visit interaction, and baseline QIDS-SR-16 total score by visit interaction are fixed effects in the model; pooled center is a random effect.
    Comparison groups
    AZD6765 50 mg v Placebo
    Number of subjects included in analysis
    198
    Analysis specification
    Pre-specified
    Analysis type
    P-value
    = 0.788 [17]
    Method
    Mixed models for repeated measures
    Parameter type
    LS mean difference
    Point estimate
    -0.2
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -1.98
         upper limit
    1.51
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.89
    Notes
    [17] - Analysis for change in QIDS-SR-16 total score from baseline to Week 12
    Statistical analysis title
    Change in QIDS-SR-16 score - baseline to Week 12
    Statistical analysis description
    MMRM includes treatment, pooled center, visit, treatment by visit interaction, and baseline QIDS-SR-16 total score by visit interaction as explanatory variables. Treatment, visit, treatment by visit interaction, and baseline QIDS-SR-16 total score by visit interaction are fixed effects in the model; pooled center is a random effect.
    Comparison groups
    AZD6765 100 mg v Placebo
    Number of subjects included in analysis
    197
    Analysis specification
    Pre-specified
    Analysis type
    P-value
    = 0.133 [18]
    Method
    Mixed models for repeated measures
    Parameter type
    LS mean difference
    Point estimate
    1.4
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -0.42
         upper limit
    3.12
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.9
    Notes
    [18] - Analysis for changed in QIDS-SR-16 total score from baseline to Week 12

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Adverse events were collected from the time of signature of informed consent throughout the treatment period and follow-up period.
    Adverse event reporting additional description
    The AZD6765iv (intravenous) 100 mg group had one less subject than the numbers provided in the Participant Flow Module because one subject who was randomized did not receive any study medication and thus was excluded from the efficacy and safety analysis sets.
    Assessment type
    Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    MedDRA
    Dictionary version
    16.0
    Reporting groups
    Reporting group title
    AZD6765iv 100 mg
    Reporting group description
    Intravenous infusion

    Reporting group title
    AZD6765iv 50 mg
    Reporting group description
    Intravenous infusion

    Reporting group title
    Placebo
    Reporting group description
    Intravenous infusion

    Serious adverse events
    AZD6765iv 100 mg AZD6765iv 50 mg Placebo
    Total subjects affected by serious adverse events
         subjects affected / exposed
    4 / 100 (4.00%)
    2 / 101 (1.98%)
    4 / 100 (4.00%)
         number of deaths (all causes)
    0
    0
    0
         number of deaths resulting from adverse events
    0
    0
    0
    Injury, poisoning and procedural complications
    ALCOHOL POISONING
         subjects affected / exposed
    0 / 100 (0.00%)
    0 / 101 (0.00%)
    1 / 100 (1.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    ASTHMA
         subjects affected / exposed
    0 / 100 (0.00%)
    1 / 101 (0.99%)
    0 / 100 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Blood and lymphatic system disorders
    ANAEMIA
         subjects affected / exposed
    0 / 100 (0.00%)
    1 / 101 (0.99%)
    0 / 100 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    General disorders and administration site conditions
    NON-CARDIAC CHEST PAIN
         subjects affected / exposed
    0 / 100 (0.00%)
    0 / 101 (0.00%)
    1 / 100 (1.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Psychiatric disorders
    DEPRESSIVE SYMPTOM
         subjects affected / exposed
    1 / 100 (1.00%)
    0 / 101 (0.00%)
    0 / 100 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    INTENTIONAL DRUG MISUSE
         subjects affected / exposed
    1 / 100 (1.00%)
    0 / 101 (0.00%)
    0 / 100 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    MAJOR DEPRESSION
         subjects affected / exposed
    1 / 100 (1.00%)
    0 / 101 (0.00%)
    0 / 100 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    SUICIDAL IDEATION
         subjects affected / exposed
    0 / 100 (0.00%)
    0 / 101 (0.00%)
    1 / 100 (1.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    SUICIDE ATTEMPT
         subjects affected / exposed
    0 / 100 (0.00%)
    0 / 101 (0.00%)
    1 / 100 (1.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Infections and infestations
    HEPATITIS C
         subjects affected / exposed
    1 / 100 (1.00%)
    0 / 101 (0.00%)
    0 / 100 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    AZD6765iv 100 mg AZD6765iv 50 mg Placebo
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    68 / 100 (68.00%)
    59 / 101 (58.42%)
    47 / 100 (47.00%)
    Nervous system disorders
    DIZZINESS
         subjects affected / exposed
    45 / 100 (45.00%)
    27 / 101 (26.73%)
    10 / 100 (10.00%)
         occurrences all number
    205
    63
    17
    HEADACHE
         subjects affected / exposed
    17 / 100 (17.00%)
    20 / 101 (19.80%)
    18 / 100 (18.00%)
         occurrences all number
    29
    28
    28
    SEDATION
         subjects affected / exposed
    7 / 100 (7.00%)
    5 / 101 (4.95%)
    5 / 100 (5.00%)
         occurrences all number
    26
    18
    13
    SOMNOLENCE
         subjects affected / exposed
    6 / 100 (6.00%)
    9 / 101 (8.91%)
    7 / 100 (7.00%)
         occurrences all number
    12
    16
    9
    General disorders and administration site conditions
    FATIGUE
         subjects affected / exposed
    6 / 100 (6.00%)
    5 / 101 (4.95%)
    5 / 100 (5.00%)
         occurrences all number
    6
    6
    6
    FEELING DRUNK
         subjects affected / exposed
    6 / 100 (6.00%)
    1 / 101 (0.99%)
    0 / 100 (0.00%)
         occurrences all number
    38
    1
    0
    Psychiatric disorders
    DISSOCIATION
         subjects affected / exposed
    8 / 100 (8.00%)
    4 / 101 (3.96%)
    4 / 100 (4.00%)
         occurrences all number
    37
    6
    7
    INSOMNIA
         subjects affected / exposed
    6 / 100 (6.00%)
    5 / 101 (4.95%)
    4 / 100 (4.00%)
         occurrences all number
    6
    6
    4
    Gastrointestinal disorders
    CONSTIPATION
         subjects affected / exposed
    6 / 100 (6.00%)
    2 / 101 (1.98%)
    5 / 100 (5.00%)
         occurrences all number
    6
    2
    5
    DIARRHOEA
         subjects affected / exposed
    5 / 100 (5.00%)
    7 / 101 (6.93%)
    5 / 100 (5.00%)
         occurrences all number
    7
    10
    6
    DRY MOUTH
         subjects affected / exposed
    6 / 100 (6.00%)
    3 / 101 (2.97%)
    2 / 100 (2.00%)
         occurrences all number
    17
    5
    3
    NAUSEA
         subjects affected / exposed
    21 / 100 (21.00%)
    13 / 101 (12.87%)
    13 / 100 (13.00%)
         occurrences all number
    26
    13
    16
    Musculoskeletal and connective tissue disorders
    BACK PAIN
         subjects affected / exposed
    1 / 100 (1.00%)
    7 / 101 (6.93%)
    2 / 100 (2.00%)
         occurrences all number
    1
    9
    2
    Infections and infestations
    UPPER RESPIRATORY TRACT INFECTION
         subjects affected / exposed
    6 / 100 (6.00%)
    7 / 101 (6.93%)
    4 / 100 (4.00%)
         occurrences all number
    7
    8
    4

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    Substantial protocol amendments (globally)

    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    16 Feb 2012
    Clarifications regarding timing of assessments, strengthening of requirements for contraception to also include male patients and male partners, addition of a new exclusion criterion for patients who during the past 2 years have met DSM IV-R-TR diagnostic criteria for post-traumatic stress disorder, addition of ethanol and methaqualone to exclusion criterion #8, modification of exclusion criterion #12 to exclude patients with a C-SSRS evaluation of type 4 or 5 within the last 6 months of screening or randomization, deletion of sub-criterion regarding insulin use in exclusion criterion #15, addition of laboratory values that signify a major medical illness that is inadequately controlled to exclusion criterion #18, exclusion criterion # 21 was revised to not limit the exclusions to hospitalizations for MDD only, addition of an exclusion criterion (#22) to clarify that a failed SAFER interview excludes a patient from participating in the study.
    25 Oct 2012
    Increase in the number of study sites, clarification that, to be eligible for the study, patients’ lifetime history of inadequate response to 3 or more antidepressant treatments must include the current antidepressant medication, exclusion criterion #11 was revised to allow for repeat testing, addition of a new exclusion criterion to exclude patients with a current diagnosis of sleep apnea, addition of a new exclusion criterion to exclude patients with a BMI ≥45 kg/m2, removal of the SAFER interview, removal of the 8-week observation period, addition of a 14-day follow-up visit.

    Interruptions (globally)

    Were there any global interruptions to the trial? No

    Limitations and caveats

    Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.
    None reported
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