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    Clinical Trial Results:
    An exploratory, blinded, randomized, placebo-controlled study in subjects with depressive disorder to investigate the effect of minocycline on relapse after successful intravenous ketamine/minocycline-induced (partial) symptoms response

    Summary
    EudraCT number
    2012-002954-21
    Trial protocol
    BE   NL   ES  
    Global end of trial date
    10 Jul 2014

    Results information
    Results version number
    v1(current)
    This version publication date
    23 Jun 2016
    First version publication date
    23 Jun 2016
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    KETIVEDI2001
    Additional study identifiers
    ISRCTN number
    -
    US NCT number
    NCT01809340
    WHO universal trial number (UTN)
    -
    Sponsors
    Sponsor organisation name
    Janssen-Cilag International N.V.
    Sponsor organisation address
    Archimedesweg 29, Leiden, Netherlands, 2333CM
    Public contact
    Clinical Registry Group, Janssen-Cilag International NV, 3171 524 21 66, ClinicalTrialsEU@its.jnj.com
    Scientific contact
    Clinical Registry Group, Janssen-Cilag International NV, 3171 524 21 66, ClinicalTrialsEU@its.jnj.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
    10 Jul 2014
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    10 Jul 2014
    Was the trial ended prematurely?
    Yes
    General information about the trial
    Main objective of the trial
    The primary objective of this study was to assess whether the antidepressant response to intravenous (IV) ketamine can be maintained by minocycline compared to placebo.
    Protection of trial subjects
    Safety and tolerability of the participants and assessment of suicidal ideation and behavior using the CSSRS, were evaluated by monitoring of adverse events (AEs), physical examination, body weight, supine vital signs, digital pulse oximetry, 12-lead electrocardiogram (ECG), and continuous ECG monitoring.
    Background therapy
    -
    Evidence for comparator
    -
    Actual start date of recruitment
    19 Jun 2013
    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
    Belgium: 14
    Country: Number of subjects enrolled
    France: 7
    Country: Number of subjects enrolled
    Netherlands: 8
    Worldwide total number of subjects
    29
    EEA total number of subjects
    29
    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)
    25
    From 65 to 84 years
    4
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    -

    Pre-assignment
    Screening details
    A total of 29 participants were enrolled with Major Depressive Disorder (MDD) or Bipolar Depression Disorder (BPD) of Type II were randomized and treated.

    Period 1
    Period 1 title
    12-Day Treatment Phase
    Is this the baseline period?
    Yes
    Allocation method
    Not applicable
    Blinding used
    Not blinded

    Arms
    Arm title
    Open Label: Ketamine/ Minocycline (12 Days)
    Arm description
    Participants received intravenous infusion of 0.5 milligram/kilogram (mg/kg) of body weight ketamine over 40 minutes on Days 1, 3, 5, 8, 10, and 12 in combination with minocycline 100 mg, orally administered twice daily.
    Arm type
    Experimental

    Investigational medicinal product name
    Ketamine
    Investigational medicinal product code
    Other name
    Ketamine Hydrochloride
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Intravenous use
    Dosage and administration details
    Participants were administered ketamine hydrochloride Intravenous (IV) injection at a dose of 50 milligram(s)/ 5 millilitre (mg/ml) over 40 minutes on Days 1, 3, 5, 8, 10, and 12.

    Investigational medicinal product name
    Minocycline Hydrochloride
    Investigational medicinal product code
    Other name
    Minocin - hard capsule - 100 mg
    Pharmaceutical forms
    Capsule, hard
    Routes of administration
    Oral use
    Dosage and administration details
    Participants were administered with Minocycline 200 mg (milligrams) capsule (2*100mg=200mg) on day 1, and 100 mg twice daily on days 2 to 11 and 100 mg on the morning of day 12 orally.

    Number of subjects in period 1
    Open Label: Ketamine/ Minocycline (12 Days)
    Started
    29
    Completed
    29
    Period 2
    Period 2 title
    6-Week Treatment Phase
    Is this the baseline period?
    No
    Allocation method
    Randomised - controlled
    Blinding used
    Double blind
    Roles blinded
    Subject, Investigator

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    Ketamine non-responders: Minocycline
    Arm description
    Participants without ketamine response (ketamine non-responders) in 12-day open label treatment phase self-administered minocycline 100 milligram (mg), orally twice daily from Day 12 to Day 54.
    Arm type
    Experimental

    Investigational medicinal product name
    Minocycline Hydrochloride
    Investigational medicinal product code
    Other name
    Minocin - hard capsule - 100 mg
    Pharmaceutical forms
    Capsule, hard
    Routes of administration
    Oral use
    Dosage and administration details
    Participants were administered with Minocycline 100 mg capsule twice daily from Day 12 to Day 54, orally.

    Arm title
    Ketamine responders: Minocycline
    Arm description
    Participants with ketamine response (ketamine responders) in 12-day open label treatment phase self administered minocycline 100 milligram (mg), orally twice daily from Day 12 to Day 54.
    Arm type
    Experimental

    Investigational medicinal product name
    Minocycline Hydrochloride
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule, hard
    Routes of administration
    Oral use
    Dosage and administration details
    Participants were administered with Minocycline 100 mg capsule twice daily from Day 12 to Day 54, orally.

    Arm title
    Ketamine responders: Placebo
    Arm description
    Participants with ketamine response (ketamine responders) in 12-day open label treatment phase self administered placebo matching with minocycline orally twice daily from Day 12 to Day 54.
    Arm type
    Placebo

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule, hard
    Routes of administration
    Oral use
    Dosage and administration details
    Participants were administered with placebo during treatment period.

    Number of subjects in period 2 [1]
    Ketamine non-responders: Minocycline Ketamine responders: Minocycline Ketamine responders: Placebo
    Started
    5
    7
    7
    Completed
    4
    7
    5
    Not completed
    1
    0
    2
         Other
    1
    -
    -
         Randomised but not treated
    -
    -
    1
         Lost to follow-up
    -
    -
    1
    Notes
    [1] - The number of subjects starting the period is not consistent with the number completing the preceding period. It is expected the number of subjects starting the subsequent period will be the same as the number completing the preceding period.
    Justification: 10 participants who were ketamine non-responders from the 12-day Open Label Treatment Phase did not enter the optional 6-week Open label treatment phase.

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Open Label: Ketamine/ Minocycline (12 Days)
    Reporting group description
    Participants received intravenous infusion of 0.5 milligram/kilogram (mg/kg) of body weight ketamine over 40 minutes on Days 1, 3, 5, 8, 10, and 12 in combination with minocycline 100 mg, orally administered twice daily.

    Reporting group values
    Open Label: Ketamine/ Minocycline (12 Days) Total
    Number of subjects
    29 29
    Title for AgeCategorical
    Units: subjects
        Children (2-11 years)
    0 0
        Adolescents (12-17 years)
    0 0
        Adults (18-64 years)
    25 25
        From 65 to 84 years
    4 4
        85 years and over
    0 0
    Title for AgeContinuous
    Units: years
        arithmetic mean (standard deviation)
    50.5 ± 12.53 -
    Title for Gender
    Units: subjects
        Female
    16 16
        Male
    13 13

    End points

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    End points reporting groups
    Reporting group title
    Open Label: Ketamine/ Minocycline (12 Days)
    Reporting group description
    Participants received intravenous infusion of 0.5 milligram/kilogram (mg/kg) of body weight ketamine over 40 minutes on Days 1, 3, 5, 8, 10, and 12 in combination with minocycline 100 mg, orally administered twice daily.
    Reporting group title
    Ketamine non-responders: Minocycline
    Reporting group description
    Participants without ketamine response (ketamine non-responders) in 12-day open label treatment phase self-administered minocycline 100 milligram (mg), orally twice daily from Day 12 to Day 54.

    Reporting group title
    Ketamine responders: Minocycline
    Reporting group description
    Participants with ketamine response (ketamine responders) in 12-day open label treatment phase self administered minocycline 100 milligram (mg), orally twice daily from Day 12 to Day 54.

    Reporting group title
    Ketamine responders: Placebo
    Reporting group description
    Participants with ketamine response (ketamine responders) in 12-day open label treatment phase self administered placebo matching with minocycline orally twice daily from Day 12 to Day 54.

    Primary: Percentage of subjects who were relapse-free (among responders) on Day54 (Week 6)

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    End point title
    Percentage of subjects who were relapse-free (among responders) on Day54 (Week 6) [1]
    End point description
    A participants was defined as “relapsed” if Montgomery-Asberg Depression Rating Scale (MADRS) total score had returned to greater than or equal to 30 after at least the first dose administration of minocycline or placebo in the 6-week blinded, treatment phase. The Montgomery-Asberg Depression Rating Scale (MADRS) measures depression severity and detects changes due to antidepressant treatment. The test consists of 10 items, each of which is scored from 0 (item not present or normal) to 6 (severe or continuous presence of the symptoms), for a total score of 60. Higher scores represent a more severe condition by Treatment. Intent to treat (ITT) analysis set included all subjects who received at least 1 dose of study drug and had both baseline and at least 1 post-baseline MADRS total score. Data for this endpoint was collected from only who were ketamine responders.
    End point type
    Primary
    End point timeframe
    Day 54 (Week 6)
    Notes
    [1] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: Statistical analysis was not reported as inferential analysis was not performed as planned.
    End point values
    Ketamine responders: Minocycline Ketamine responders: Placebo
    Number of subjects analysed
    7
    7
    Units: Percentage
        number (not applicable)
    85.7
    57.1
    No statistical analyses for this end point

    Secondary: Change in MADRS total score from Day 12 to end-of-study (Day 54)

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    End point title
    Change in MADRS total score from Day 12 to end-of-study (Day 54)
    End point description
    The Montgomery-Asberg Depression Rating Scale (MADRS) measures depression severity and detects changes due to antidepressant treatment. The test consists of 10 items, each of which is scored from 0 (item not present or normal) to 6 (severe or continuous presence of the symptoms), for a total score of 60. Higher scores represent a more severe condition. ITT population. Here "n" signifies number of subjects who were analysed for this outcome measure at specific time points.
    End point type
    Secondary
    End point timeframe
    Day 12 and Day 54
    End point values
    Ketamine responders: Minocycline Ketamine responders: Placebo
    Number of subjects analysed
    7
    6
    Units: units on a scale
    arithmetic mean (standard deviation)
        Day 12 (n=7, 6)
    9.6 ± 6.65
    8.2 ± 4.26
        Change at Day 54 (n= 6, 2)
    1 ± 2.53
    4.5 ± 2.12
    No statistical analyses for this end point

    Secondary: Change in the MADRS total score from baseline during ketamine treatment phase (Days 1, 3, 5, 8, 10 and 12)

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    End point title
    Change in the MADRS total score from baseline during ketamine treatment phase (Days 1, 3, 5, 8, 10 and 12)
    End point description
    The Montgomery-Asberg Depression Rating Scale (MADRS) measures depression severity and detects changes due to antidepressant treatment. The test consists of 10 items, each of which is scored from 0 (item not present or normal) to 6 (severe or continuous presence of the symptoms), for a total score of 60. Higher scores represent a more severe condition. ITT population. Here "n" signifies number of subjects who were analysed for this outcome measure at specific time points.
    End point type
    Secondary
    End point timeframe
    Day 1 Predose and Days 1, 3, 5, 8, 10 and 12
    End point values
    Open Label: Ketamine/ Minocycline (12 Days)
    Number of subjects analysed
    29
    Units: Unit on a scale
    arithmetic mean (standard deviation)
        Predose Day 1
    33 ± 5
        Change at Day 1 (n=29)
    -8.7 ± 8.57
        Change at Day 3 (n=29)
    -11.9 ± 7.66
        Change at Day 5 (n=29)
    -14.2 ± 8.35
        Change at Day 8 (n=29)
    -15.7 ± 9.17
        Change at Day 10 (n=28)
    -17 ± 9.2
        Change at Day 12 (n=26)
    -15.6 ± 10.62
    No statistical analyses for this end point

    Secondary: Change in the MADRS total score from baseline after the IV ketamine treatment phase (Days 20, 27, 34, 41, 48, and 54)

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    End point title
    Change in the MADRS total score from baseline after the IV ketamine treatment phase (Days 20, 27, 34, 41, 48, and 54)
    End point description
    The Montgomery-Asberg Depression Rating Scale (MADRS) measures depression severity and detects changes due to antidepressant treatment. The test consists of 10 items, each of which is scored from 0 (item not present or normal) to 6 (severe or continuous presence of the symptoms), for a total score of 60. Higher scores represent a more severe condition. ITT population. Here "n" signifies number of subjects who were analysed for this outcome measure at specific time points.
    End point type
    Secondary
    End point timeframe
    Day 1 and days 20, 27, 34, 41, 48, and 54.
    End point values
    Ketamine responders: Minocycline Ketamine responders: Placebo
    Number of subjects analysed
    7
    7
    Units: unit on a scale
    arithmetic mean (standard deviation)
        Day 1 Predose (n=7, 6)
    33 ± 7.46
    33 ± 3.27
        Change at Day 20 (n= 7, 6)
    -19.9 ± 10.88
    -20 ± 7.97
        Change at Day 27 (n= 6, 6)
    -22 ± 8.37
    -17.3 ± 16.74
        Change at Day 34 (n= 6, 5)
    -20 ± 8.94
    -25.4 ± 5.59
        Change at Day 41 (n= 6, 4)
    -18.2 ± 9.6
    -17.3 ± 12.2
        Change at Day 48 (n= 6, 3)
    -20.3 ± 9.95
    -25 ± 6.08
        Change at Day 54 (n= 6, 3)
    -21.8 ± 8.42
    -23 ± 5.29
    No statistical analyses for this end point

    Secondary: Percentage of Participants with Response during the IV ketamine treatment phase (Days 1, 3, 5, 8, 10 and 12)

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    End point title
    Percentage of Participants with Response during the IV ketamine treatment phase (Days 1, 3, 5, 8, 10 and 12)
    End point description
    End point type
    Secondary
    End point timeframe
    Days 1, 3, 5, 8, 10 and 12
    End point values
    Open Label: Ketamine/ Minocycline (12 Days)
    Number of subjects analysed
    29
    Units: percentage of participants
        number (not applicable)
    48
    No statistical analyses for this end point

    Secondary: Median Time to Relapse

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    End point title
    Median Time to Relapse
    End point description
    End point type
    Secondary
    End point timeframe
    Day 12 up to End of Study (Day 54)
    End point values
    Ketamine responders: Minocycline Ketamine responders: Placebo
    Number of subjects analysed
    0 [2]
    0 [3]
    Units: Days
        median (full range (min-max))
    ( to )
    ( to )
    Notes
    [2] - Median levels were not reached due to the early stopping / small sample size.
    [3] - Median levels were not reached due to the early stopping / small sample size.
    No statistical analyses for this end point

    Secondary: Columbia Suicide Severity Rating Scale (C-SSRS) Score

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    End point title
    Columbia Suicide Severity Rating Scale (C-SSRS) Score
    End point description
    End point type
    Secondary
    End point timeframe
    From Screening up to follow-up (Day 54)
    End point values
    Ketamine non-responders: Minocycline Ketamine responders: Minocycline Ketamine responders: Placebo
    Number of subjects analysed
    0 [4]
    0 [5]
    0 [6]
    Units: unit on a scale
        number (not applicable)
    Notes
    [4] - Data for this endpoint was not summarized and individual data were listed.
    [5] - Data for this endpoint was not summarized and individual data were listed.
    [6] - Data for this endpoint was not summarized and individual data were listed.
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    From Screening up to follow-up (Day 54)
    Assessment type
    Non-systematic
    Dictionary used for adverse event reporting
    Dictionary name
    MedDRA
    Dictionary version
    16.1
    Reporting groups
    Reporting group title
    Open Label: Ketamine/ Minocycline (12 Days)
    Reporting group description
    Participants received intravenous infusion of 0.5 milligram/kilogram of body weight (mg/kg) ketamine over 40 minutes on Days 1, 3, 5, 8, 10, and 12 in combination with minocycline 100 mg, orally administered twice daily.

    Reporting group title
    Ketamine responders: Placebo
    Reporting group description
    Participants with ketamine response (ketamine responders) in 12-day open label treatment phase selfadministered placebo matching with minocycline orally twice daily from Day 12 to Day 54.

    Reporting group title
    Ketamine responders: Minocycline
    Reporting group description
    Participants with ketamine response (ketamine responders) in 12-day open label treatment phase selfadministered minocycline 100 milligram (mg), orally twice daily from Day 12 to Day 54.

    Reporting group title
    Minocycline 100 mg BID Open Label 6 Weeks
    Reporting group description
    Participants with ketamine response (ketamine responders) in 12-day open label treatment phase self administered placebo matching with minocycline orally twice daily from Day 12 to Day 54.

    Serious adverse events
    Open Label: Ketamine/ Minocycline (12 Days) Ketamine responders: Placebo Ketamine responders: Minocycline Minocycline 100 mg BID Open Label 6 Weeks
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 29 (0.00%)
    1 / 6 (16.67%)
    0 / 7 (0.00%)
    1 / 5 (20.00%)
         number of deaths (all causes)
    0
    0
    0
    0
         number of deaths resulting from adverse events
    Psychiatric disorders
    Anxiety
    alternative assessment type: Systematic
         subjects affected / exposed
    0 / 29 (0.00%)
    1 / 6 (16.67%)
    0 / 7 (0.00%)
    1 / 5 (20.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    Open Label: Ketamine/ Minocycline (12 Days) Ketamine responders: Placebo Ketamine responders: Minocycline Minocycline 100 mg BID Open Label 6 Weeks
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    25 / 29 (86.21%)
    3 / 6 (50.00%)
    6 / 7 (85.71%)
    4 / 5 (80.00%)
    Vascular disorders
    Hypertension
    alternative assessment type: Systematic
         subjects affected / exposed
    1 / 29 (3.45%)
    1 / 6 (16.67%)
    0 / 7 (0.00%)
    0 / 5 (0.00%)
         occurrences all number
    1
    1
    0
    0
    Hot flush
         subjects affected / exposed
    0 / 29 (0.00%)
    0 / 6 (0.00%)
    1 / 7 (14.29%)
    0 / 5 (0.00%)
         occurrences all number
    0
    0
    1
    0
    General disorders and administration site conditions
    Fatigue
    alternative assessment type: Systematic
         subjects affected / exposed
    3 / 29 (10.34%)
    0 / 6 (0.00%)
    0 / 7 (0.00%)
    0 / 5 (0.00%)
         occurrences all number
    4
    0
    0
    0
    Feeling Abnormal
    alternative assessment type: Systematic
         subjects affected / exposed
    2 / 29 (6.90%)
    0 / 6 (0.00%)
    1 / 7 (14.29%)
    0 / 5 (0.00%)
         occurrences all number
    6
    0
    1
    0
    Feeling of Relaxation
    alternative assessment type: Systematic
         subjects affected / exposed
    4 / 29 (13.79%)
    0 / 6 (0.00%)
    0 / 7 (0.00%)
    0 / 5 (0.00%)
         occurrences all number
    8
    0
    0
    0
    Psychiatric disorders
    Affect Lability
    alternative assessment type: Systematic
         subjects affected / exposed
    2 / 29 (6.90%)
    0 / 6 (0.00%)
    1 / 7 (14.29%)
    0 / 5 (0.00%)
         occurrences all number
    4
    0
    2
    0
    Anxiety
    alternative assessment type: Systematic
         subjects affected / exposed
    4 / 29 (13.79%)
    0 / 6 (0.00%)
    1 / 7 (14.29%)
    0 / 5 (0.00%)
         occurrences all number
    9
    0
    1
    0
    Bradyphrenia
    alternative assessment type: Systematic
         subjects affected / exposed
    2 / 29 (6.90%)
    0 / 6 (0.00%)
    0 / 7 (0.00%)
    0 / 5 (0.00%)
         occurrences all number
    2
    0
    0
    0
    Depressed Mood
    alternative assessment type: Systematic
         subjects affected / exposed
    1 / 29 (3.45%)
    1 / 6 (16.67%)
    1 / 7 (14.29%)
    0 / 5 (0.00%)
         occurrences all number
    4
    2
    1
    0
    Dissociation
    alternative assessment type: Systematic
         subjects affected / exposed
    12 / 29 (41.38%)
    2 / 6 (33.33%)
    2 / 7 (28.57%)
    2 / 5 (40.00%)
         occurrences all number
    48
    2
    2
    2
    Elevated Mood
    alternative assessment type: Systematic
         subjects affected / exposed
    1 / 29 (3.45%)
    0 / 6 (0.00%)
    1 / 7 (14.29%)
    0 / 5 (0.00%)
         occurrences all number
    2
    0
    1
    0
    Insomnia
    alternative assessment type: Systematic
         subjects affected / exposed
    2 / 29 (6.90%)
    0 / 6 (0.00%)
    0 / 7 (0.00%)
    0 / 5 (0.00%)
         occurrences all number
    2
    0
    0
    0
    Negative Thoughts
    alternative assessment type: Systematic
         subjects affected / exposed
    0 / 29 (0.00%)
    1 / 6 (16.67%)
    0 / 7 (0.00%)
    0 / 5 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Suicidal Ideation
    alternative assessment type: Systematic
         subjects affected / exposed
    0 / 29 (0.00%)
    1 / 6 (16.67%)
    0 / 7 (0.00%)
    0 / 5 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Tension
    alternative assessment type: Systematic
         subjects affected / exposed
    1 / 29 (3.45%)
    1 / 6 (16.67%)
    0 / 7 (0.00%)
    0 / 5 (0.00%)
         occurrences all number
    2
    2
    0
    0
    Dissociative disorder
         subjects affected / exposed
    1 / 29 (3.45%)
    0 / 6 (0.00%)
    0 / 7 (0.00%)
    1 / 5 (20.00%)
         occurrences all number
    5
    0
    0
    1
    Reproductive system and breast disorders
    Breast Tenderness
    alternative assessment type: Systematic
         subjects affected / exposed
    0 / 29 (0.00%)
    0 / 6 (0.00%)
    1 / 7 (14.29%)
    0 / 5 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Injury, poisoning and procedural complications
    Contusion
    alternative assessment type: Systematic
         subjects affected / exposed
    0 / 29 (0.00%)
    0 / 6 (0.00%)
    1 / 7 (14.29%)
    0 / 5 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Investigations
    Blood Pressure Increased
    alternative assessment type: Systematic
         subjects affected / exposed
    1 / 29 (3.45%)
    0 / 6 (0.00%)
    1 / 7 (14.29%)
    0 / 5 (0.00%)
         occurrences all number
    5
    0
    1
    0
    Nervous system disorders
    Dizziness
    alternative assessment type: Systematic
         subjects affected / exposed
    8 / 29 (27.59%)
    1 / 6 (16.67%)
    1 / 7 (14.29%)
    1 / 5 (20.00%)
         occurrences all number
    26
    1
    1
    1
    Dysarthria
    alternative assessment type: Systematic
         subjects affected / exposed
    3 / 29 (10.34%)
    0 / 6 (0.00%)
    0 / 7 (0.00%)
    0 / 5 (0.00%)
         occurrences all number
    4
    0
    0
    0
    Headache
    alternative assessment type: Systematic
         subjects affected / exposed
    11 / 29 (37.93%)
    1 / 6 (16.67%)
    2 / 7 (28.57%)
    1 / 5 (20.00%)
         occurrences all number
    18
    2
    4
    1
    Hyperaesthesia
    alternative assessment type: Systematic
         subjects affected / exposed
    0 / 29 (0.00%)
    1 / 6 (16.67%)
    0 / 7 (0.00%)
    0 / 5 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Hypoaesthesia
    alternative assessment type: Systematic
         subjects affected / exposed
    1 / 29 (3.45%)
    0 / 6 (0.00%)
    1 / 7 (14.29%)
    0 / 5 (0.00%)
         occurrences all number
    3
    0
    1
    0
    Migraine
    alternative assessment type: Systematic
         subjects affected / exposed
    1 / 29 (3.45%)
    0 / 6 (0.00%)
    2 / 7 (28.57%)
    0 / 5 (0.00%)
         occurrences all number
    1
    0
    2
    0
    Somnolence
    alternative assessment type: Systematic
         subjects affected / exposed
    4 / 29 (13.79%)
    0 / 6 (0.00%)
    0 / 7 (0.00%)
    1 / 5 (20.00%)
         occurrences all number
    9
    0
    0
    1
    Sciatica
         subjects affected / exposed
    0 / 29 (0.00%)
    0 / 6 (0.00%)
    1 / 7 (14.29%)
    0 / 5 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Eye disorders
    Diplopia
    alternative assessment type: Systematic
         subjects affected / exposed
    4 / 29 (13.79%)
    0 / 6 (0.00%)
    1 / 7 (14.29%)
    0 / 5 (0.00%)
         occurrences all number
    7
    0
    1
    0
    Vision Blurred
    alternative assessment type: Systematic
         subjects affected / exposed
    4 / 29 (13.79%)
    0 / 6 (0.00%)
    1 / 7 (14.29%)
    0 / 5 (0.00%)
         occurrences all number
    8
    0
    1
    0
    Gastrointestinal disorders
    Abdominal Discomfort
    alternative assessment type: Systematic
         subjects affected / exposed
    2 / 29 (6.90%)
    0 / 6 (0.00%)
    0 / 7 (0.00%)
    0 / 5 (0.00%)
         occurrences all number
    2
    0
    0
    0
    Diarrhoea
    alternative assessment type: Systematic
         subjects affected / exposed
    0 / 29 (0.00%)
    0 / 6 (0.00%)
    1 / 7 (14.29%)
    0 / 5 (0.00%)
         occurrences all number
    1
    0
    1
    0
    Dry Mouth
    alternative assessment type: Systematic
         subjects affected / exposed
    2 / 29 (6.90%)
    0 / 6 (0.00%)
    0 / 7 (0.00%)
    0 / 5 (0.00%)
         occurrences all number
    2
    0
    0
    0
    Hypoaesthesia Oral
    alternative assessment type: Systematic
         subjects affected / exposed
    2 / 29 (6.90%)
    0 / 6 (0.00%)
    0 / 7 (0.00%)
    0 / 5 (0.00%)
         occurrences all number
    3
    0
    0
    0
    Nausea
    alternative assessment type: Systematic
         subjects affected / exposed
    5 / 29 (17.24%)
    1 / 6 (16.67%)
    1 / 7 (14.29%)
    1 / 5 (20.00%)
         occurrences all number
    9
    1
    1
    1
    Skin and subcutaneous tissue disorders
    Hyperhidrosis
    alternative assessment type: Systematic
         subjects affected / exposed
    2 / 29 (6.90%)
    0 / 6 (0.00%)
    0 / 7 (0.00%)
    0 / 5 (0.00%)
         occurrences all number
    2
    0
    0
    0
    Musculoskeletal and connective tissue disorders
    Muscle Tightness
    alternative assessment type: Systematic
         subjects affected / exposed
    0 / 29 (0.00%)
    0 / 6 (0.00%)
    0 / 7 (0.00%)
    1 / 5 (20.00%)
         occurrences all number
    0
    0
    0
    1
    Myalgia
    alternative assessment type: Systematic
         subjects affected / exposed
    0 / 29 (0.00%)
    0 / 6 (0.00%)
    1 / 7 (14.29%)
    0 / 5 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Metabolism and nutrition disorders
    Increased Appetite
    alternative assessment type: Systematic
         subjects affected / exposed
    0 / 29 (0.00%)
    1 / 6 (16.67%)
    0 / 7 (0.00%)
    0 / 5 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Infections and infestations
    Gastroenteritis
    alternative assessment type: Systematic
         subjects affected / exposed
    0 / 29 (0.00%)
    0 / 6 (0.00%)
    0 / 7 (0.00%)
    1 / 5 (20.00%)
         occurrences all number
    0
    0
    0
    1
    Rash Pustular
    alternative assessment type: Systematic
         subjects affected / exposed
    0 / 29 (0.00%)
    0 / 6 (0.00%)
    1 / 7 (14.29%)
    0 / 5 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Tinea Pedis
    alternative assessment type: Systematic
         subjects affected / exposed
    0 / 29 (0.00%)
    0 / 6 (0.00%)
    0 / 7 (0.00%)
    1 / 5 (20.00%)
         occurrences all number
    0
    0
    0
    1

    More information

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    Substantial protocol amendments (globally)

    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    07 Aug 2013
    The first amendment was released to revise to facilitate participant recruitment (without changing the aims of the protocol) and provide further clarification regarding participant eligibility requirements.
    18 Mar 2014
    The second amendment was released to amend the criteria for Ketamine responder criteria were amended to reflect normal variation in response. Additionally the maximum number of concomitant psychotropic drugs were increased to better reflect clinical practice.

    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.
    Study was terminated prematurely due to slow recruitment resulting in expiration of trial supplies Inability to secure new trial supplies due to availability issues.
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