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    Clinical Trial Results:
    A Randomized, 6-Week, Double-Blind, Placebo-Controlled, Flexible-Dose, Parallel-Group Study of Lurasidone for the Treatment of Major Depressive Disorder with Mixed Features

    Summary
    EudraCT number
    2012-004132-33
    Trial protocol
    GB  
    Global end of trial date
    01 Oct 2014

    Results information
    Results version number
    v1(current)
    This version publication date
    02 Sep 2016
    First version publication date
    02 Sep 2016
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    D1050304
    Additional study identifiers
    ISRCTN number
    -
    US NCT number
    NCT01421134
    WHO universal trial number (UTN)
    -
    Sponsors
    Sponsor organisation name
    Sunovion Pharmaceuticals Inc.
    Sponsor organisation address
    One Bridge PlazaNorth, Suite 510, Fort Lee, United States, 07024
    Public contact
    Manager, Sunovion Pharmaceuticals Inc., 001 1-866-503-6351, clinicaltrialdisclosure@sunvion.com
    Scientific contact
    Director, Sunovion Pharmaceuticals Inc., 001 1-866-503-6351, clinicaltrialdisclosure@sunvion.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
    01 Oct 2014
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    01 Oct 2014
    Global end of trial reached?
    Yes
    Global end of trial date
    01 Oct 2014
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    Lurasidone HCl is a compound that is a candidate for the treatment of major depressive with mixed features.This clinical study is designed to test how well Lurasidone works to treat major depressive disorder with mixed features.
    Protection of trial subjects
    This trial was conducted in accordance with the ethical principles of Good Clinical Practice, according to the ICH Harmonized Tripartite Guideline.
    Background therapy
    -
    Evidence for comparator
    -
    Actual start date of recruitment
    01 Sep 2011
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    Yes
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Russian Federation: 31
    Country: Number of subjects enrolled
    United States: 60
    Country: Number of subjects enrolled
    Ukraine: 62
    Country: Number of subjects enrolled
    United Kingdom: 4
    Country: Number of subjects enrolled
    Serbia: 52
    Worldwide total number of subjects
    209
    EEA total number of subjects
    4
    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)
    203
    From 65 to 84 years
    6
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    A Randomized, 6-Week, Double-Blind, Placebo-Controlled, Flexible-Dose, Parallel-Group Study of lurasidone for the Treatment of Major Depressive Disorder with Mixed Features. This study enrolled subjects at 44 sites in 5 countries, enrollment started on 01Sept2011.

    Pre-assignment
    Screening details
    Subjects were evaluated for eligibility during a screening period of up to 14 days. Subjects were washed out from prior or concomitant medications, where applicable, prior to randomization.Treatment with prior psychotropic medications.

    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, Carer, Subject, Assessor

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    lurasidone
    Arm description
    lurasidone 20, 40 or 60 mg lurasidone: 20, 40, 60 mg, flexible dose, once daily PM 6 weeks
    Arm type
    Experimental

    Investigational medicinal product name
    lurasidone
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    once daily

    Arm title
    Placebo
    Arm description
    Placebo Placebo: Placebo
    Arm type
    Placebo

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    once daily

    Number of subjects in period 1
    lurasidone Placebo
    Started
    109
    100
    Completed
    102
    85
    Not completed
    7
    15
         Protocol deviation
    -
    3
         Lack of efficacy
    2
    4
         Adverse event, non-fatal
    3
    5
         Consent withdrawn by subject
    1
    1
         Administrative
    -
    1
         Lost to follow-up
    1
    1

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    lurasidone
    Reporting group description
    lurasidone 20, 40 or 60 mg lurasidone: 20, 40, 60 mg, flexible dose, once daily PM 6 weeks

    Reporting group title
    Placebo
    Reporting group description
    Placebo Placebo: Placebo

    Reporting group values
    lurasidone Placebo Total
    Number of subjects
    109 100 209
    Age Categorical
    Units: participants
        <=18 years
    1 0 1
        Between 18 and 65 years
    106 96 202
        >=65 years
    2 4 6
    Age Continuous
    Units: years
        arithmetic mean (standard deviation)
    43.6 ± 12.08 46.4 ± 12.01 -
    Gender, Male/Female
    Units: participants
        Female
    73 72 145
        Male
    36 28 64
    Race (NIH/OMB)
    Units: Subjects
        American Indian or Alaska Native
    0 0 0
        Asian
    0 1 1
        Native Hawaiian or Other Pacific Islander
    0 0 0
        Black or African American
    14 12 26
        White
    94 86 180
        More than one race
    0 0 0
        Unknown or Not Reported
    1 1 2
    Region of Enrollment
    Units: Subjects
        Russian Federation
    18 13 31
        United States
    34 26 60
        Ukraine
    30 32 62
        United Kingdom
    1 3 4
        Serbia
    26 26 52

    End points

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    End points reporting groups
    Reporting group title
    lurasidone
    Reporting group description
    lurasidone 20, 40 or 60 mg lurasidone: 20, 40, 60 mg, flexible dose, once daily PM 6 weeks

    Reporting group title
    Placebo
    Reporting group description
    Placebo Placebo: Placebo

    Primary: Mean Change from baseline to the 6-week study endpoint in Montgomery-Asberg Depression Rating Scale (MADRS) total scores

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    End point title
    Mean Change from baseline to the 6-week study endpoint in Montgomery-Asberg Depression Rating Scale (MADRS) total scores
    End point description
    The MADRS consists of 10 items, each rated on a Likert scale, from 0=”Normal” to 6=”Most Severe”. The MADRS total score is calculated as the sum of the 10 items. The MADRS total score ranges from 0 to 60. Higher scores are associated with greater severity.
    End point type
    Primary
    End point timeframe
    Baseline to Week 6
    End point values
    lurasidone Placebo
    Number of subjects analysed
    108
    100
    Units: units on a scale
        least squares mean (standard error)
    -20.5 ± 0.95
    -13 ± 1
    Statistical analysis title
    STATISTICAL_ANALYSIS_TITLE
    Comparison groups
    lurasidone v Placebo
    Number of subjects included in analysis
    208
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    < 0.0001
    Method
    Mixed models analysis
    Parameter type
    Least Square Mean Difference
    Point estimate
    -7.5
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -10.2
         upper limit
    -4.8
    Variability estimate
    Standard error of the mean
    Dispersion value
    1.37

    Secondary: Mean change from baseline to the 6-week study endpoint in the Clinical Global Impression-Severity of Illness (CGI-S) score

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    End point title
    Mean change from baseline to the 6-week study endpoint in the Clinical Global Impression-Severity of Illness (CGI-S) score
    End point description
    The CGI-S score is a single value, clinician-rated assessment of illness severity and ranges from 1= ‘Normal, not at all ill’ to 7= ‘Among the most extremely ill patients’. A higher score is associated with greater illness severity.
    End point type
    Secondary
    End point timeframe
    Baseline to Week 6
    End point values
    lurasidone Placebo
    Number of subjects analysed
    108
    100
    Units: units on a scale
        least squares mean (standard error)
    -1.83 ± 0.109
    -1.18 ± 0.115
    Statistical analysis title
    STATISTICAL_ANALYSIS_TITLE
    Comparison groups
    lurasidone v Placebo
    Number of subjects included in analysis
    208
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    < 0.0001
    Method
    Mixed models analysis
    Parameter type
    Least Square Mean Difference
    Point estimate
    -0.65
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -0.96
         upper limit
    -0.34
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.157

    Secondary: Mean change from baseline to Week 6 in the Young Mania Rating Scale (YMRS) total score

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    End point title
    Mean change from baseline to Week 6 in the Young Mania Rating Scale (YMRS) total score
    End point description
    The YMRS is an 11-item clinician-rated instrument used to assess the severity of mania. Seven items are rated on a 5-point scale, ranging from 0 to 4, and four items are rated on a 9-point scale, ranging from 0 to 8. The YMRS total score is calculated as the sum of the 11 individual items and ranges from 0 to 60. Higher scores are associated with greater severity of mania.
    End point type
    Secondary
    End point timeframe
    Baseline to Week 6
    End point values
    lurasidone Placebo
    Number of subjects analysed
    108
    100
    Units: units on a scale
        least squares mean (standard error)
    -7 ± 0.35
    -4.9 ± 0.37
    Statistical analysis title
    STATISTICAL_ANALYSIS_TITLE
    Statistical analysis description
    last observation carried forward (LOCF)
    Comparison groups
    lurasidone v Placebo
    Number of subjects included in analysis
    208
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    < 0.0001
    Method
    Mixed models analysis
    Parameter type
    Least Square Mean Difference
    Point estimate
    -2.1
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -3.1
         upper limit
    -1.1
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.5

    Secondary: Mean change from baseline to week 6 in the Sheehan Disability Scale (SDS) total score

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    End point title
    Mean change from baseline to week 6 in the Sheehan Disability Scale (SDS) total score
    End point description
    The SDS is a composite of three self-rated items designed to measure the extent to which three major sectors (work/school, social life/leisure, and family life/home responsibility) in the patient’s life are impaired by depressive symptoms. These three items are responded to on a visual analogue scale (VAS) ranging through 0 (no impairment), 1–3 (mild), 4–6 (moderate), 7–9 (marked) and 10 (extreme) disability. The SDS total score is calculated as the sum of the three items and ranges from 0 (unimpaired) to 30 (highly impaired).
    End point type
    Secondary
    End point timeframe
    Baseline to Week 6
    End point values
    lurasidone Placebo
    Number of subjects analysed
    70
    69
    Units: units on a scale
        least squares mean (standard error)
    -11.2 ± 0.88
    -6.4 ± 0.88
    Statistical analysis title
    STATISTICAL_ANALYSIS_TITLE
    Comparison groups
    lurasidone v Placebo
    Number of subjects included in analysis
    139
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.0001
    Method
    ANCOVA
    Parameter type
    Least Square Mean Difference
    Point estimate
    -4.8
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -7.2
         upper limit
    -2.4
    Variability estimate
    Standard error of the mean
    Dispersion value
    1.21

    Secondary: Mean change from baseline to week 6 in the Hamilton Rating Scale for Anxiety(HAM-A) total score

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    End point title
    Mean change from baseline to week 6 in the Hamilton Rating Scale for Anxiety(HAM-A) total score
    End point description
    The HAM-A is used to quantify the severity of anxiety symptomatology and consists of 14 items. Each item is rated on a 5-point scale, ranging from 0 (not present) to 4 (severe/disabling). The HAM-A total score is calculated as the sum of the 14 individual items and ranges from 0 to 56. Higher scores are associated with greater degree of anxiety.
    End point type
    Secondary
    End point timeframe
    Baseline to Week 6
    End point values
    lurasidone Placebo
    Number of subjects analysed
    105
    98
    Units: units on a scale
        least squares mean (standard error)
    -9.9 ± 0.58
    -5.4 ± 0.59
    Statistical analysis title
    STATISTICAL_ANALYSIS_TITLE
    Statistical analysis description
    last observation carried forward (LOCF)
    Comparison groups
    lurasidone v Placebo
    Number of subjects included in analysis
    203
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    < 0.0001
    Method
    ANCOVA
    Parameter type
    Least Square Mean Difference
    Point estimate
    -4.5
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -6.1
         upper limit
    -2.9
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.81

    Secondary: Percentage of subjects who achieve a response, defined as ≥ 50% reduction from baseline on the Montgomery-Asberg Depression Rating Scale (MADRS) total score at week 6 (LOCF).

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    End point title
    Percentage of subjects who achieve a response, defined as ≥ 50% reduction from baseline on the Montgomery-Asberg Depression Rating Scale (MADRS) total score at week 6 (LOCF).
    End point description
    End point type
    Secondary
    End point timeframe
    Baseline to Week 6
    End point values
    lurasidone Placebo
    Number of subjects analysed
    108
    100
    Units: percentage of subjects
        number (not applicable)
    64.8
    30
    Statistical analysis title
    STATISTICAL_ANALYSIS_TITLE
    Comparison groups
    lurasidone v Placebo
    Number of subjects included in analysis
    208
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    < 0.0001
    Method
    Regression, Logistic
    Parameter type
    Odds ratio (OR)
    Point estimate
    6.615
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    3.251
         upper limit
    13.459

    Secondary: Percentage of subjects who achieve a remission, defined as a Montgomery-Asberg Depression Rating Scale (MADRS) total score of ≤ 12 at Week 6 (LOCF)

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    End point title
    Percentage of subjects who achieve a remission, defined as a Montgomery-Asberg Depression Rating Scale (MADRS) total score of ≤ 12 at Week 6 (LOCF)
    End point description
    End point type
    Secondary
    End point timeframe
    Baseline to Week 6
    End point values
    lurasidone Placebo
    Number of subjects analysed
    108
    100
    Units: percentage of subjects
        number (not applicable)
    49.1
    23
    Statistical analysis title
    STATISTICAL_ANALYSIS_TITLE
    Comparison groups
    lurasidone v Placebo
    Number of subjects included in analysis
    208
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    < 0.0001
    Method
    Regression, Logistic
    Parameter type
    Odds ratio (OR)
    Point estimate
    4.27
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    2.105
         upper limit
    8.663

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    6 Weeks
    Assessment type
    Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    MedDRA
    Dictionary version
    14.0
    Reporting groups
    Reporting group title
    Placebo
    Reporting group description
    Placebo Placebo: Placebo

    Reporting group title
    Lurasidone
    Reporting group description
    Lurasidone 20, 40 or 60 mg Lurasidone: 20, 40, 60 mg, flexible dose, once daily PM 6 weeks

    Serious adverse events
    Placebo Lurasidone
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 100 (0.00%)
    1 / 109 (0.92%)
         number of deaths (all causes)
    0
    0
         number of deaths resulting from adverse events
    0
    0
    Psychiatric disorders
    Depression Suicidal
         subjects affected / exposed
    0 / 100 (0.00%)
    1 / 109 (0.92%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 2%
    Non-serious adverse events
    Placebo Lurasidone
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    29 / 100 (29.00%)
    31 / 109 (28.44%)
    Injury, poisoning and procedural complications
    Contusion
         subjects affected / exposed
    2 / 100 (2.00%)
    0 / 109 (0.00%)
         occurrences all number
    2
    0
    Nervous system disorders
    Headache
         subjects affected / exposed
    6 / 100 (6.00%)
    6 / 109 (5.50%)
         occurrences all number
    7
    6
    Somnoelence
         subjects affected / exposed
    1 / 100 (1.00%)
    5 / 109 (4.59%)
         occurrences all number
    1
    6
    Akathisia
         subjects affected / exposed
    2 / 100 (2.00%)
    4 / 109 (3.67%)
         occurrences all number
    2
    4
    Dizziness
         subjects affected / exposed
    3 / 100 (3.00%)
    4 / 109 (3.67%)
         occurrences all number
    3
    5
    Psychiatric disorders
    Insomnia
         subjects affected / exposed
    11 / 100 (11.00%)
    6 / 109 (5.50%)
         occurrences all number
    11
    7
    Anxiety
         subjects affected / exposed
    9 / 100 (9.00%)
    4 / 109 (3.67%)
         occurrences all number
    12
    4
    Gastrointestinal disorders
    Nausea
         subjects affected / exposed
    2 / 100 (2.00%)
    7 / 109 (6.42%)
         occurrences all number
    2
    7
    Abdominal discomfort
         subjects affected / exposed
    1 / 100 (1.00%)
    4 / 109 (3.67%)
         occurrences all number
    1
    5
    Dry mouth
         subjects affected / exposed
    1 / 100 (1.00%)
    3 / 109 (2.75%)
         occurrences all number
    1
    3
    Renal and urinary disorders
    Haemarturia
         subjects affected / exposed
    2 / 100 (2.00%)
    0 / 109 (0.00%)
         occurrences all number
    2
    0
    Skin and subcutaneous tissue disorders
    Pruritus
         subjects affected / exposed
    2 / 100 (2.00%)
    1 / 109 (0.92%)
         occurrences all number
    2
    1
    Infections and infestations
    Urinary Tract Infection
         subjects affected / exposed
    2 / 100 (2.00%)
    1 / 109 (0.92%)
         occurrences all number
    3
    1

    More information

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    Substantial protocol amendments (globally)

    Were there any global substantial amendments to the protocol? No

    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
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