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    Clinical Trial Results:
    A Phase 2a Randomized, Double-blind, Placebo-controlled, Parallel-group, Multi-center Study Investigating the Efficacy, Safety, and Tolerability of JNJ-42165279 in Subjects with Major Depressive Disorder and Anxious Distress

    Summary
    EudraCT number
    		 2015-002007-29
    Trial protocol
    		 ES   GB  
    Global end of trial date
    04 Feb 2019

    Results information
    Results version number
    		 v1(current)
    This version publication date
    19 Feb 2020
    First version publication date
    19 Feb 2020
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    42165279MDD2001
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT02498392
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Janssen Research & Development, LLC
    Sponsor organisation address
    920 Route 202, South Raritan, United States,
    Public contact
    Clinical Registry Group, Janssen Research & Development, LLC, ClinicalTrialsEU@its.jnj.com
    Scientific contact
    Clinical Registry Group, Janssen Research & Development, LLC, 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
    04 Feb 2019
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    04 Feb 2019
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The primary objective of this study was to evaluate the efficacy in terms of reduction of symptoms of depression and anxiety, as assessed by the change from baseline on a 17-item Hamilton Depression Rating Scale (HDRS17), and overall safety and tolerability of treatment with adjunctive JNJ-42165279 compared to placebo in subjects with major depressive disorder (MDD) with anxiety symptoms who had inadequate response to treatment with a selective serotonin reuptake inhibitor (SSRI) or serotonergic/noradrenergic reuptake inhibitor (SNRI).
    Protection of trial subjects
    This study was conducted in accordance with the ethical principles that have their origin in the Declaration of Helsinki and that are consistent with Good Clinical Practices and applicable regulatory requirements. Physical examination, neurological examination, vital signs, body weight, body temperature, clinical laboratory assessments, 12-lead electrocardiogram (ECG), urine drug screen, alcohol screening test, pregnancy testing, Columbia Suicide Severity Rating Scale (C-SSRS) assessments and evaluation of adverse events (AEs) and concomitant medications were performed during the study to monitor subject's safety.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    08 Oct 2015
    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
    Spain: 6
    Country: Number of subjects enrolled
    United Kingdom: 35
    Country: Number of subjects enrolled
    Moldova, Republic of: 18
    Country: Number of subjects enrolled
    Russian Federation: 44
    Country: Number of subjects enrolled
    Ukraine: 39
    Country: Number of subjects enrolled
    United States: 18
    Worldwide total number of subjects
    160
    EEA total number of subjects
    41
    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)
    160
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 -

    Pre-assignment
    Screening details
    		 A total of 160 subjects were enrolled into the lead-in period, and 153 were randomized into the double-blind (DB) treatment period and received at least 1 dose of double-blind study agent. Of the 153 subjects, 137 completed study.

    Period 1
    Period 1 title
    Double-blind (DB) Lead-in Period
    Is this the baseline period?
    		 No
    Allocation method
    Non-randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Subject, Investigator

    Arms
    Arm title
    		 Placebo
    Arm description
    		 Lead-in Period: All subjects received matching placebo tablets orally once daily (qd). At the end of the lead-in period, response status of the subjects was assessed according to the double-blind response criteria based on reduction in Hamilton Depression Rating Scale (HDRS17) relative to lead-in baseline. Double-blind treatment period: Following initial placebo lead-in period, subjects self-administered adjunctive matching placebo tablets orally qd for 6 weeks. Withdrawal period: Subjects who completed the double-blind treatment period prior to Week 11 were treated with placebo for the remaining time of the treatment phase of the study, which varied depending on the duration of the placebo lead-in for the specific subject.
    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
    Matching placebo was administered orally.

    Number of subjects in period 1
    		Placebo
    Started
    160
    Completed
    153
    Not completed
    7
         Did not receive treatment
    7
    Period 2
    Period 2 title
    DB Treatment(6 week) + Withdrawal Period
    Is this the baseline period?
    		 Yes [1]
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Subject, Investigator

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Placebo
    Arm description
    		 Lead-in Period: All subjects received matching placebo tablets orally once daily (qd). At the end of the lead-in period, response status of the subjects was assessed according to the double-blind response criteria based on reduction in HDRS17 relative to lead-in baseline. Double-blind treatment period: Following initial placebo lead-in period, subjects self-administered adjunctive matching placebo tablets orally qd for 6 weeks. Withdrawal period: Subjects who completed the double-blind treatment period prior to Week 11 were treated with placebo for the remaining time of the treatment phase of the study, which varied depending on the duration of the placebo lead-in for the specific subject.
    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
    Matching placebo was administered orally.

    Arm title
    		 JNJ-42165279 25 mg
    Arm description
    		 Double-blind treatment period: Following the initial placebo lead-in period, the subjects self-administered JNJ-42165279 25 mg tablets orally once daily for 6 weeks.
    Arm type
    		 Experimental

    Investigational medicinal product name
    JNJ-42165279
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    JNJ-42165279 was administered orally at a dose of 25 mg tablet once daily for 6 weeks.

    Notes
    [1] - Period 1 is not the baseline period. It is expected that period 1 will be the baseline period.
    Justification: Baseline data was reported for safety analysis set for DB treatment period which was less than all enrolled analysis set.
    Number of subjects in period 2 [2]
    		Placebo JNJ-42165279 25 mg
    Started
    76
    77
    Completed
    70
    67
    Not completed
    6
    10
         Adverse Event
    3
    -
         Unspecified
    1
    3
         Lost to follow-up
    -
    2
         Withdrawal by subject
    2
    3
         Lack of efficacy
    -
    2
    Notes
    [2] - The number of subjects reported to be in the baseline period are not the same as the worldwide number enrolled in the trial. It is expected that these numbers will be the same.
    Justification: The baseline period shows the disposition of safety analysis set.

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Placebo
    Reporting group description
    		 Lead-in Period: All subjects received matching placebo tablets orally once daily (qd). At the end of the lead-in period, response status of the subjects was assessed according to the double-blind response criteria based on reduction in HDRS17 relative to lead-in baseline. Double-blind treatment period: Following initial placebo lead-in period, subjects self-administered adjunctive matching placebo tablets orally qd for 6 weeks. Withdrawal period: Subjects who completed the double-blind treatment period prior to Week 11 were treated with placebo for the remaining time of the treatment phase of the study, which varied depending on the duration of the placebo lead-in for the specific subject.

    Reporting group title
    JNJ-42165279 25 mg
    Reporting group description
    		 Double-blind treatment period: Following the initial placebo lead-in period, the subjects self-administered JNJ-42165279 25 mg tablets orally once daily for 6 weeks.

    Reporting group values
    		 Placebo JNJ-42165279 25 mg Total
    Number of subjects
    		 76 77 153
    Title for AgeCategorical
    Units: subjects
        Children (2-11 years)
    		 0 0 0
        Adolescents (12-17 years)
    		 0 0 0
        Adults (18-64 years)
    		 76 77 153
        From 65 to 84 years
    		 0 0 0
        85 years and over
    		 0 0 0
    Title for AgeContinuous
    Units: years
        arithmetic mean (standard deviation)
    		 44.4 ( 11.92 ) 42.1 ( 11.96 ) -
    Title for Gender
    Units: subjects
        Female
    		 59 53 112
        Male
    		 17 24 41

    End points

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    End points reporting groups
    Reporting group title
    Placebo
    Reporting group description
    		 Lead-in Period: All subjects received matching placebo tablets orally once daily (qd). At the end of the lead-in period, response status of the subjects was assessed according to the double-blind response criteria based on reduction in Hamilton Depression Rating Scale (HDRS17) relative to lead-in baseline. Double-blind treatment period: Following initial placebo lead-in period, subjects self-administered adjunctive matching placebo tablets orally qd for 6 weeks. Withdrawal period: Subjects who completed the double-blind treatment period prior to Week 11 were treated with placebo for the remaining time of the treatment phase of the study, which varied depending on the duration of the placebo lead-in for the specific subject.
    Reporting group title
    Placebo
    Reporting group description
    		 Lead-in Period: All subjects received matching placebo tablets orally once daily (qd). At the end of the lead-in period, response status of the subjects was assessed according to the double-blind response criteria based on reduction in HDRS17 relative to lead-in baseline. Double-blind treatment period: Following initial placebo lead-in period, subjects self-administered adjunctive matching placebo tablets orally qd for 6 weeks. Withdrawal period: Subjects who completed the double-blind treatment period prior to Week 11 were treated with placebo for the remaining time of the treatment phase of the study, which varied depending on the duration of the placebo lead-in for the specific subject.

    Reporting group title
    JNJ-42165279 25 mg
    Reporting group description
    		 Double-blind treatment period: Following the initial placebo lead-in period, the subjects self-administered JNJ-42165279 25 mg tablets orally once daily for 6 weeks.

    Primary: Double-blind Treatment Period: Change from Baseline in Hamilton Depression Rating Scale (HDRS17) Total Score at Week 6 (eITT Population)

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    End point title
    		 Double-blind Treatment Period: Change from Baseline in Hamilton Depression Rating Scale (HDRS17) Total Score at Week 6 (eITT Population)
    End point description
    HDRS-17 is clinician-administered rating scale designed to assess severity of symptoms in subjects diagnosed with depression. Each of 17 items is rated by clinician on either 3-point (0-2) or 5-point (0-4) scale with rating of 0:absent, 1:doubtful to mild, 2:mild to moderate, 3:moderate to severe, and 4:very severe. A total score (0 to 52) was calculated by adding scores of all 17 items. For each item as well as total score, higher score represents more severe condition. The enriched intention-to-treat (eITT) analysis set included all enrolled subjects who were randomized into double-blind treatment period, who were lead-in placebo non-responder, who received at least one dose of double-blind study medication (either placebo or JNJ-42165279) and had at least one post-baseline HDRS17 assessment in double-blind treatment period. Here 'N' (number of subjects analyzed) signifies number of subjects who were evaluable for this endpoint.
    End point type
    Primary
    End point timeframe
    Baseline and Week 6
    End point values
    		 Placebo JNJ-42165279 25 mg
    Number of subjects analysed
    47
    47
    Units: Units on a scale
        arithmetic mean (standard deviation)
    -6.1 ( 5.90 )
    -6.5 ( 4.01 )
    Statistical analysis title
    		 Statistical Analysis 1
    Statistical analysis description
    Here 'MMRM' refers to Mixed-effects Model Using Repeated Measures.
    Comparison groups
    Placebo v JNJ-42165279 25 mg
    Number of subjects included in analysis
    94
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.416
    Method
    		 MMRM
    Parameter type
    		 Difference of Least Square (LS) Means
    Point estimate
    -0.2
    Confidence interval
         level
    		 60%
         sides
    2-sided
         lower limit
    		 -1.1
         upper limit
    		 0.66
    Variability estimate
    Standard error of the mean
    Dispersion value
    1.04

    Primary: Double-blind Treatment Period: Change from Baseline in Hamilton Depression Rating Scale (HDRS17) Total Score at Week 6 (fITT Population)

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    End point title
    		 Double-blind Treatment Period: Change from Baseline in Hamilton Depression Rating Scale (HDRS17) Total Score at Week 6 (fITT Population)
    End point description
    HDRS17 is a clinician-administered rating scale designed to assess severity of symptoms in subjects diagnosed with depression. Each of the 17 items is rated by clinician on either a 3-point (0 to 2) or a 5-point (0 to 4) scale which used a rating of 0:absent, 1:doubtful to mild, 2:mild to moderate, 3:moderate to severe, and 4:very severe. HDRS17 total score is calculated as sum of 17 item scores and ranges from 0 to 52. For each item as well as the total score, higher scores indicate greater severity of depression. The full intent-to-treat (fITT) analysis set included both placebo responders and placebo non-responders. Here 'N' (number of subjects analyzed) signifies number of subjects who were evaluable for this endpoint.
    End point type
    Primary
    End point timeframe
    Baseline and Week 6
    End point values
    		 Placebo JNJ-42165279 25 mg
    Number of subjects analysed
    72
    69
    Units: Units on a scale
        arithmetic mean (standard deviation)
    -5.0 ( 6.34 )
    -5.2 ( 4.68 )
    Statistical analysis title
    		 Statistical Analysis 1
    Statistical analysis description
    Here 'MMRM' refers to Mixed-effects Model Using Repeated Measures.
    Comparison groups
    Placebo v JNJ-42165279 25 mg
    Number of subjects included in analysis
    141
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.647 [1]
    Method
    		 MMRM
    Parameter type
    		 Difference of Least Square (LS) Means
    Point estimate
    0.3
    Confidence interval
         level
    		 60%
         sides
    2-sided
         lower limit
    		 -0.41
         upper limit
    		 1.07
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.88
    Notes
    [1] - 1-sided

    Secondary: Double-blind Treatment Period: Change from Baseline in Hamilton Anxiety Rating Subscale (HAM-A6) Score at Week 6 (eITT Population)

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    End point title
    		 Double-blind Treatment Period: Change from Baseline in Hamilton Anxiety Rating Subscale (HAM-A6) Score at Week 6 (eITT Population)
    End point description
    The HAM-A6 is a 6-item subscale derived from the original Hamilton Anxiety scale (HAM-A) which consists of 5 psychic anxiety symptoms (anxious mood, psychic tension, fears, intellectual disturbances, and anxious behavior observed at the interview), as well as one somatic item (muscular tension). The HAM-A6 score ranges from 0 to 24; higher scores indicate greater severity of symptoms. The HAM-A6 score is calculated by summing the 6 item scores. The eITT analysis set included all enrolled subjects who were randomized into double-blind treatment period, who were lead-in placebo non-responder, who received at least one dose of double-blind study medication (either placebo or JNJ-42165279) and had at least one post-baseline HDRS17 assessment in the double-blind treatment period. Here 'N' (number of subjects analyzed) signifies number of subjects who were evaluable for this endpoint.
    End point type
    Secondary
    End point timeframe
    Baseline and Week 6
    End point values
    		 Placebo JNJ-42165279 25 mg
    Number of subjects analysed
    47
    47
    Units: Units on a scale
        arithmetic mean (standard deviation)
    -2.4 ( 3.15 )
    -2.9 ( 2.47 )
    No statistical analyses for this end point

    Secondary: Double-blind Treatment Period: Change from Baseline in Hamilton Depression Rating Subscale (HAM-D6) Score at Week 6 (eITT Population)

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    End point title
    		 Double-blind Treatment Period: Change from Baseline in Hamilton Depression Rating Subscale (HAM-D6) Score at Week 6 (eITT Population)
    End point description
    HAM-D6 is a 6-item subscale derived from HDRS17 and consists of depressed mood, guilt feelings, work and interests, psychomotor retardation, psychic anxiety, and somatics symptoms (tiredness and pains), rated on a 5-point scale, where 0 = not present, and 1-4 represent increasingly severe symptoms. One item (that is, somatic symptoms) is rated on only a 3-point scale, ranging from 0-2. The HAM-D6 is calculated from summing the 6 items and the score ranges from 0 (normal) to 22 (severe), with higher scores indicating greater severity of core symptoms. The eITT analysis set included all enrolled subjects who were randomized into double-blind treatment period, who were lead-in placebo non-responder, who received at least one dose of double-blind study medication (either placebo or JNJ-42165279) and had at least one post-baseline HDRS17 assessment in double-blind treatment period. Here 'N' (number of subjects analyzed) signifies number of subjects who were evaluable for this endpoint.
    End point type
    Secondary
    End point timeframe
    Baseline and Week 6
    End point values
    		 Placebo JNJ-42165279 25 mg
    Number of subjects analysed
    47
    47
    Units: Units on a scale
        arithmetic mean (standard deviation)
    -3.1 ( 3.20 )
    -3.6 ( 2.41 )
    No statistical analyses for this end point

    Secondary: Double-blind Treatment Period: Change from Baseline in Structured Interview Guide of the Hamilton Anxiety Scale (SIGH-A) Total Score at Week 6 (eITT Population)

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    End point title
    		 Double-blind Treatment Period: Change from Baseline in Structured Interview Guide of the Hamilton Anxiety Scale (SIGH-A) Total Score at Week 6 (eITT Population)
    End point description
    The SIGH-A scale consists of 14 items with a score of 0 to 4, where 0=absent, 1=mild, 2=moderate, 3=severe, 4=incapacitating. The SIGH-A total score is calculated by summing the 14 item scores, and ranges from 0 to 56. For each individual item score and total score, higher scores indicate greater severity. The eITT analysis set included all enrolled subjects who were randomized into double-blind treatment period, who were lead-in placebo non-responder, who received at least one dose of double-blind study medication (either placebo or JNJ-42165279) and had at least one post-baseline HDRS17 assessment in the double-blind treatment period. Here 'N' (number of subjects analyzed) signifies number of subjects who were evaluable for this endpoint.
    End point type
    Secondary
    End point timeframe
    Baseline and Week 6
    End point values
    		 Placebo JNJ-42165279 25 mg
    Number of subjects analysed
    47
    47
    Units: Units on a scale
        arithmetic mean (standard deviation)
    -5.7 ( 7.11 )
    -6.8 ( 5.62 )
    No statistical analyses for this end point

    Secondary: Double-blind Treatment Period: Change from Baseline in the HDRS17 Anxiety/Somatization Factor Total Score at Week 6 (eITT Population)

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    End point title
    		 Double-blind Treatment Period: Change from Baseline in the HDRS17 Anxiety/Somatization Factor Total Score at Week 6 (eITT Population)
    End point description
    HDRS17 anxiety/somatization factor is derived from HDRS including 6 items: psychic anxiety, somatic anxiety, gastrointestinal somatic symptoms, general somatic symptoms, hypochondriasis, and insight. Each of 6 items is rated by clinician on either a 3-point (0 to 2) or a 5-point (0 to 4) scale with rating of 0:absent, 1:doubtful to mild, 2:mild to moderate, 3:moderate to severe, and 4:very severe and is calculated as sum of 6 item scores ranging from 0 to 18, with higher scores indicating greater severity of symptoms for each item as well as total score. The eITT analysis set included all enrolled subjects who were randomized into DB treatment period, who were lead-in placebo non-responder, who received at least one dose of double-blind study medication (either placebo or JNJ-42165279) and had at least one post-baseline HDRS17 assessment in double-blind treatment period. Here 'N' (number of subjects analyzed) signifies number of subjects who were evaluable for this endpoint.
    End point type
    Secondary
    End point timeframe
    Baseline and Week 6
    End point values
    		 Placebo JNJ-42165279 25 mg
    Number of subjects analysed
    47
    47
    Units: Units on a scale
        arithmetic mean (standard deviation)
    -2.1 ( 2.35 )
    -2.3 ( 1.55 )
    No statistical analyses for this end point

    Secondary: Double-blind Treatment Period: Percentage of Subjects With Greater than or Equal to (>=) 30 Percent (%) Improvement on the HDRS-17 Total Score at Week 6 (eITT Population)

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    End point title
    		 Double-blind Treatment Period: Percentage of Subjects With Greater than or Equal to (>=) 30 Percent (%) Improvement on the HDRS-17 Total Score at Week 6 (eITT Population)
    End point description
    Percentage of subjects who had >=30% improvement on HDRS17 total score at Week 6 was reported. HDRS-17 is clinician-administered rating scale designed to assess severity of symptoms in subjects diagnosed with depression. Each of 17 items is rated by clinician on either 3-point (0-2) or 5-point (0-4) scale with rating of 0:absent, 1:doubtful to mild, 2:mild to moderate, 3:moderate to severe, and 4:very severe. A total score (0 to 52) was calculated by adding scores of all 17 items. For each item as well as total score, higher score represents more severe condition. eITT analysis set included all enrolled subjects who were randomized into DB treatment period,who were lead-in placebo non-responder, who received at least one dose of double-blind study medication (either placebo or JNJ-42165279) and had at least one post-baseline HDRS17 assessment in double-blind treatment period. Here 'N' (number of subjects analyzed) signifies number of subjects who were evaluable for this endpoint.
    End point type
    Secondary
    End point timeframe
    Week 6
    End point values
    		 Placebo JNJ-42165279 25 mg
    Number of subjects analysed
    47
    47
    Units: Percentage of subjects
        number (not applicable)
    51.1
    55.3
    No statistical analyses for this end point

    Secondary: Double-blind Treatment Period: Percentage of Subjects With >= 50% Improvement on the HDRS-17 Total Score at Week 6 (eITT Population)

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    End point title
    		 Double-blind Treatment Period: Percentage of Subjects With >= 50% Improvement on the HDRS-17 Total Score at Week 6 (eITT Population)
    End point description
    Percentage of subjects who had >=50% improvement on HDRS17 total score at Week 6 was reported. HDRS-17 is clinician-administered rating scale designed to assess severity of symptoms in subjects diagnosed with depression. Each of 17 items is rated by clinician on either 3-point (0-2) or 5-point (0-4) scale with rating of 0:absent, 1:doubtful to mild, 2:mild to moderate, 3:moderate to severe, and 4:very severe. A total score (0 to 52) was calculated by adding scores of all 17 items. For each item as well as total score, higher score represents more severe condition. eITT analysis set included all enrolled subjects who were randomized into DB treatment period,who were lead-in placebo non-responder, who received at least one dose of double-blind study medication (either placebo or JNJ-42165279) and had at least one post-baseline HDRS-17 assessment in DB treatment period. Here 'N' (number of subjects analyzed) signifies number of subjects who were evaluable for this endpoint.
    End point type
    Secondary
    End point timeframe
    Week 6
    End point values
    		 Placebo JNJ-42165279 25 mg
    Number of subjects analysed
    47
    47
    Units: Percentage of subjects
        number (not applicable)
    27.7
    21.3
    No statistical analyses for this end point

    Secondary: Double-blind Treatment Period: Percentage of Subjects With Remission as Assessed by HDRS-17 Total Score at Week 6 (eITT Population)

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    End point title
    		 Double-blind Treatment Period: Percentage of Subjects With Remission as Assessed by HDRS-17 Total Score at Week 6 (eITT Population)
    End point description
    Percentage of subjects with HDRS-17 total score less than or equal to 7 were considered as remitters. HDRS-17 is clinician-administered rating scale designed to assess severity of symptoms in subjects with depression. Each of 17 items is rated by clinician on either 3-point(0-2) or 5-point(0-4) scale with rating of 0:absent,1:doubtful to mild,2:mild to moderate,3:moderate to severe, and 4:very severe. A total score (0 to 52) was calculated by adding scores of all 17 items. For each item as well as total score, higher score represents more severe condition. eITT analysis set included all enrolled subjects who were randomized into double-blind treatment period,who were lead-in placebo non-responder,who received at least one dose of double-blind study medication (either placebo or JNJ-42165279) and had at least one post-baseline HDRS17 assessment in double-blind treatment period. Here 'N' (number of subjects analyzed) signifies number of subjects who were evaluable for this endpoint.
    End point type
    Secondary
    End point timeframe
    Week 6
    End point values
    		 Placebo JNJ-42165279 25 mg
    Number of subjects analysed
    47
    47
    Units: Percentage of subjects
        number (not applicable)
    14.9
    8.5
    No statistical analyses for this end point

    Secondary: Double-blind Treatment Period: Percentage of Subjects With >= 30% Improvement on SIGH-A Total Score at Week 6 (eITT Population)

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    End point title
    		 Double-blind Treatment Period: Percentage of Subjects With >= 30% Improvement on SIGH-A Total Score at Week 6 (eITT Population)
    End point description
    The percentage of subjects who had >= 30% improvement on SIGH-A total score at Week 6 was reported. The SIGH-A scale consists of 14 items with a score of 0 to 4, where 0=absent, 1=mild, 2=moderate, 3=severe, 4=incapacitating. The SIGH-A total score is calculated by summing the 14 item scores, and ranges from 0 to 56. For each individual item score and total score, higher scores indicate greater severity. The eITT analysis set included all enrolled subjects who were randomized into double-blind treatment period, who were lead-in placebo non-responder, who received at least one dose of double-blind study medication (either placebo or JNJ-42165279) and had at least one post-baseline HDRS17 assessment in the double-blind treatment period. Here 'N' (number of subjects analyzed) signifies number of subjects who were evaluable for this endpoint.
    End point type
    Secondary
    End point timeframe
    Week 6
    End point values
    		 Placebo JNJ-42165279 25 mg
    Number of subjects analysed
    47
    47
    Units: Percentage of subjects
        number (not applicable)
    48.9
    51.1
    No statistical analyses for this end point

    Secondary: Double-blind Treatment Period: Percentage of Subjects With >= 50% Improvement on SIGH-A Total Score at Week 6 (eITT Population)

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    End point title
    		 Double-blind Treatment Period: Percentage of Subjects With >= 50% Improvement on SIGH-A Total Score at Week 6 (eITT Population)
    End point description
    The percentage of subjects who had >= 50% improvement on SIGH-A total score at Week 6 was reported. The SIGH-A scale consists of 14 items with a score of 0 to 4, where 0=absent, 1=mild, 2=moderate, 3=severe, 4=incapacitating. The SIGH-A total score is calculated by summing the 14 item scores, and ranges from 0 to 56. For each individual item score and total score, higher scores indicate greater severity. The eITT analysis set included all enrolled subjects who were randomized into double-blind treatment period, who were lead-in placebo non-responder, who received at least one dose of double-blind study medication (either placebo or JNJ-42165279) and had at least one post-baseline HDRS17 assessment in the double-blind treatment period. Here 'N' (number of subjects analyzed) signifies number of subjects who were evaluable for this endpoint.
    End point type
    Secondary
    End point timeframe
    Week 6
    End point values
    		 Placebo JNJ-42165279 25 mg
    Number of subjects analysed
    47
    47
    Units: Percentage of subjects
        number (not applicable)
    29.8
    21.3
    No statistical analyses for this end point

    Secondary: Double-blind Treatment Period: Percentage of Subjects With a Clinical Global Impression Improvement (CGI-I) Score of Very Much Improved or Much Improved at Week 6 (eITT Population)

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    End point title
    		 Double-blind Treatment Period: Percentage of Subjects With a Clinical Global Impression Improvement (CGI-I) Score of Very Much Improved or Much Improved at Week 6 (eITT Population)
    End point description
    The percentage of subjects with a CGI-I score of very much improved or much improved at Week 6 was reported. CGI-I is a 7-point scale that required the clinician to assess how much the subject’s illness had improved or worsened relative to a baseline state at the beginning of the intervention. The CGI-I is rated as: 1=very much improved; 2=much improved; 3=minimally improved; 4=no change; 5=minimally worse; 6=much worse; 7=very much worse. For each individual item score and total score, higher scores indicate greater severity. The eITT analysis set included all enrolled subjects who were randomized into double-blind treatment period, who were lead-in placebo non-responder, who received at least one dose of double-blind study medication (either placebo or JNJ-42165279) and had at least one post-baseline HDRS17 assessment in the double-blind treatment period. Here 'N' (number of subjects analyzed) signifies number of subjects who were evaluable for this endpoint.
    End point type
    Secondary
    End point timeframe
    Week 6
    End point values
    		 Placebo JNJ-42165279 25 mg
    Number of subjects analysed
    47
    47
    Units: Percentage of subjects
        number (not applicable)
    57.4
    55.3
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Up to 6 weeks
    Assessment type
    		 Non-systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    21.1
    Reporting groups
    Reporting group title
    Placebo
    Reporting group description
    		 Lead-in Period: All subjects received matching placebo tablets orally once daily (qd). At the end of the lead-in period, response status of the subjects was assessed according to the double-blind response criteria based on reduction in HDRS17 relative to lead-in baseline. Double-blind treatment period: Following initial placebo lead-in period, subjects self-administered adjunctive matching placebo tablets orally qd for 6 weeks. Withdrawal period: Subjects who completed the double-blind treatment period prior to Week 11 were treated with placebo for the remaining time of the treatment phase of the study, which varied depending on the duration of the placebo lead-in for the specific subject.

    Reporting group title
    JNJ-42165279 25mg
    Reporting group description
    		 Double-blind treatment period: Following the Lead-in Period, the subjects self-administered JNJ-42165279 25 milligrams (mg) tablets orally once daily for 6 weeks.

    Serious adverse events
    		 Placebo JNJ-42165279 25mg
    Total subjects affected by serious adverse events
         subjects affected / exposed
    1 / 76 (1.32%)
    1 / 77 (1.30%)
         number of deaths (all causes)
    0
    0
         number of deaths resulting from adverse events
    Musculoskeletal and connective tissue disorders
    Foot Deformity
         subjects affected / exposed
    0 / 76 (0.00%)
    1 / 77 (1.30%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Infections and infestations
    Gastroenteritis
         subjects affected / exposed
    1 / 76 (1.32%)
    0 / 77 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 Placebo JNJ-42165279 25mg
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    4 / 76 (5.26%)
    3 / 77 (3.90%)
    Nervous system disorders
    Headache
         subjects affected / exposed
    4 / 76 (5.26%)
    3 / 77 (3.90%)
         occurrences all number
    4
    4

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    31 Aug 2015
    The overall reason for Amendment INT-1 was to clarify the updated procedure performed by an independent central rater and to address the US Food and Drug Administration (FDA) comments.
    03 Jul 2017
    The overall reason for Amendment INT-2 was to update the information on toxicology, to increase the number of subjects participating in the study from 140 to 143, to replace 3 subjects who had to stop early when the study was put on hold, to add neurological examinations to confirm the safety of participation in the study and treatment with JNJ 42165279, to make change in allowed medication and control of drug intake.
    25 Aug 2017
    The overall reason for Amendment INT-4 was based on a regulatory decision, to allow women of childbearing potential to participate in this study under conditions of pregnancy testing and the use of high-quality contraception, and additionally, to add the optional use of a diary or electronic device to document the intake of study medication.
    24 Oct 2017
    The overall reason for Amendment INT-5 was based on regulator’s request to exclude subjects with abnormal high liver function analytes from the study, to add an exclusion criterion for breast feeding women; on request of investigators: to add Venlafaxine (immediate release) to the list of allowed antidepressant drugs, on request of investigators: to add instructions on the use of PRN (as needed) non-benzodiazepine sleep aids, and additionally, to add specific instructions of the calculation of corrected QT (QTc) interval to determine stopping or exclusion criteria.

    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.
    The relationship of plasma anandamide and trough drug concentrations observed suggest that few subjects had substantial recovery of fatty acid amide hydrolase activity between doses. Higher doses or exposures could have resulted in greater effects.
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