Clinical Trial Results:
A Phase 2a Randomized, Double-blind, Placebo-Controlled, Parallel-Group, Multi-center
Study Investigating the Efficacy, Safety, Tolerability and Pharmacokinetics of
JNJ-67953964 in Subjects with Major Depressive Disorder
Summary
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EudraCT number |
2019-000695-41 |
Trial protocol |
GB |
Global end of trial date |
06 May 2020
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Results information
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Results version number |
v1(current) |
This version publication date |
21 May 2021
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First version publication date |
21 May 2021
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Other versions |
Trial Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information
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Trial identification
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Sponsor protocol code |
67953964MDD2001
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Additional study identifiers
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ISRCTN number |
- | ||
US NCT number |
NCT03559192 | ||
WHO universal trial number (UTN) |
- | ||
Sponsors
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Sponsor organisation name |
Janssen Research & Development, LLC
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Sponsor organisation address |
920 Route 202, Raritan, United States, NJ 08869
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Public contact |
Clinical Registry group, Janssen Research & Development, LLC, ClinicalTrialsEU@its.jnj.com
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Scientific contact |
Clinical Registry group, Janssen Research & Development, LLC, ClinicalTrialsEU@its.jnj.com
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Paediatric regulatory details
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Is trial part of an agreed paediatric investigation plan (PIP) |
No
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Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial? |
No
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Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial? |
No
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Results analysis stage
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Analysis stage |
Final
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Date of interim/final analysis |
06 May 2020
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Is this the analysis of the primary completion data? |
No
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Global end of trial reached? |
Yes
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Global end of trial date |
06 May 2020
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Was the trial ended prematurely? |
No
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General information about the trial
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Main objective of the trial |
The objective of this study was to evaluate the efficacy of JNJ-67953964 (aticaprant) compared to
placebo when administered as adjunctive treatment in subjects with major depressive disorder (MDD) partially responsive to selective serotonin reuptake inhibitor (SSRI) / serotonin-norepinephrine reuptake inhibitor (SNRI) treatment in terms of reduction of symptoms of depression, as assessed by the change from baseline on the Montgomery Asberg Depression Rating Scale (MADRS) in non-responders during the placebo lead-in period.
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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 Practice (GCP) and applicable regulatory requirements. Safety was evaluated during the study through assessments: 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, arizona sexual experiences scale (ASEX) assessment, karolinska sleepiness scale (KSS) assessment, and evaluation of adverse events (AEs) and concomitant medications.
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Background therapy |
- | ||
Evidence for comparator |
- | ||
Actual start date of recruitment |
31 Jul 2018
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Long term follow-up planned |
No
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Independent data monitoring committee (IDMC) involvement? |
No
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Population of trial subjects
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Number of subjects enrolled per country |
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Country: Number of subjects enrolled |
Germany: 9
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Country: Number of subjects enrolled |
United Kingdom: 27
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Country: Number of subjects enrolled |
Moldova, Republic of: 29
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Country: Number of subjects enrolled |
Russian Federation: 47
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Country: Number of subjects enrolled |
Ukraine: 17
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Country: Number of subjects enrolled |
United States: 52
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Worldwide total number of subjects |
181
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EEA total number of subjects |
9
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Number of subjects enrolled per age group |
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In utero |
0
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Preterm newborn - gestational age < 37 wk |
0
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Newborns (0-27 days) |
0
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Infants and toddlers (28 days-23 months) |
0
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Children (2-11 years) |
0
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Adolescents (12-17 years) |
0
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Adults (18-64 years) |
181
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From 65 to 84 years |
0
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85 years and over |
0
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Recruitment
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Recruitment details |
- | |||||||||||||||||||||||||||||||||||||||
Pre-assignment
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Screening details |
A total of 181 subjects were enrolled in this study. | |||||||||||||||||||||||||||||||||||||||
Period 1
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Period 1 title |
Lead-in Period (3 Weeks)
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Is this the baseline period? |
Yes | |||||||||||||||||||||||||||||||||||||||
Allocation method |
Non-randomised - controlled
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Blinding used |
Double blind | |||||||||||||||||||||||||||||||||||||||
Roles blinded |
Subject, Investigator | |||||||||||||||||||||||||||||||||||||||
Arms
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Arm title
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Placebo | |||||||||||||||||||||||||||||||||||||||
Arm description |
Subjects with major depressive disorder (MDD) who had inadequate response to selective serotonin reuptake inhibitor /serotonin-norepinephrine reuptake inhibitor (SSRI/SNRI) treatment received JNJ-67953964 matching placebo capsules (2*1 placebo capsules) once daily starting from Day 2 to 3 weeks in lead-in period in addition to SSRI/SNRI treatment. | |||||||||||||||||||||||||||||||||||||||
Arm type |
Placebo | |||||||||||||||||||||||||||||||||||||||
Investigational medicinal product name |
Placebo
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Investigational medicinal product code |
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Other name |
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Pharmaceutical forms |
Capsule
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Routes of administration |
Oral use
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Dosage and administration details |
Matching placebo capsules (2*1 placebo capsules) were administered orally up to 3 weeks in lead-in period.
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Period 2
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Period 2 title |
Double-Blind Treatment Period (6 Weeks)
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Is this the baseline period? |
No | |||||||||||||||||||||||||||||||||||||||
Allocation method |
Randomised - controlled
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Blinding used |
Double blind | |||||||||||||||||||||||||||||||||||||||
Roles blinded |
Subject, Investigator | |||||||||||||||||||||||||||||||||||||||
Arms
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Are arms mutually exclusive |
Yes
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Arm title
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Placebo | |||||||||||||||||||||||||||||||||||||||
Arm description |
Subjects who were responders or non-responders to lead-in placebo group were re-randomized to receive JNJ-67953964 matching placebo capsules (2*1 placebo capsules) once daily during double-blind treatment period (up to 6 weeks after lead-in period) in addition to SSRI/SNRI treatment. | |||||||||||||||||||||||||||||||||||||||
Arm type |
Placebo | |||||||||||||||||||||||||||||||||||||||
Investigational medicinal product name |
Placebo
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Investigational medicinal product code |
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Other name |
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Pharmaceutical forms |
Capsule
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Routes of administration |
Oral use
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Dosage and administration details |
Matching placebo capsules (2*1 placebo capsules) were administered orally up to 6 weeks after lead-in period.
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Arm title
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JNJ-67953964 10 milligrams (mg) | |||||||||||||||||||||||||||||||||||||||
Arm description |
Subjects who were responders or non-responders to lead-in placebo group were re-randomized to receive 10 mg JNJ-67953964 capsules (2*5 mg JNJ-67953964 capsules) once daily during double-blind treatment period (up to 6 weeks after lead-in period) in addition to SSRI/SNRI treatment. | |||||||||||||||||||||||||||||||||||||||
Arm type |
Experimental | |||||||||||||||||||||||||||||||||||||||
Investigational medicinal product name |
JNJ-67953964
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Investigational medicinal product code |
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Other name |
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Pharmaceutical forms |
Capsule
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Routes of administration |
Oral use
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Dosage and administration details |
10 mg JNJ-67953964 capsules (2*5 mg JNJ-67953964 capsules) were administered orally up to 6 weeks after lead-in period.
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Notes [1] - The number of subjects at this milestone seems inconsistent with the number of subjects in the arm. It is expected that the number of subjects will be greater than, or equal to the number that completed, minus those who left. Justification: Out of 84 subjects in Placebo arm, 22 were Placebo Lead-in Responders and 62 were Placebo Lead-In Non-Responders. For JNJ-67953964 arm, out of 85 subjects: 23 were Placebo Lead-in Responders and 62 were Placebo Lead-In Non-responders. [2] - The number of subjects at this milestone seems inconsistent with the number of subjects in the arm. It is expected that the number of subjects will be greater than, or equal to the number that completed, minus those who left. Justification: Out of 84 subjects in Placebo arm, 22 were Placebo Lead-in Responders and 62 were Placebo Lead-In Non-Responders. For JNJ-67953964 arm, out of 85 subjects: 23 were Placebo Lead-in Responders and 62 were Placebo Lead-In Non-responders. [3] - The number of subjects at this milestone seems inconsistent with the number of subjects in the arm. It is expected that the number of subjects will be greater than, or equal to the number that completed, minus those who left. Justification: Out of 84 subjects in Placebo arm, 22 were Placebo Lead-in Responders and 62 were Placebo Lead-In Non-Responders. For JNJ-67953964 arm, out of 85 subjects: 23 were Placebo Lead-in Responders and 62 were Placebo Lead-In Non-responders. [4] - The number of subjects at this milestone seems inconsistent with the number of subjects in the arm. It is expected that the number of subjects will be greater than, or equal to the number that completed, minus those who left. Justification: Out of 84 subjects in Placebo arm, 22 were Placebo Lead-in Responders and 62 were Placebo Lead-In Non-Responders. For JNJ-67953964 arm, out of 85 subjects: 23 were Placebo Lead-in Responders and 62 were Placebo Lead-In Non-responders. |
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Period 3
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Period 3 title |
Withdrawal Period (2 Weeks)
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Is this the baseline period? |
No | |||||||||||||||||||||||||||||||||||||||
Allocation method |
Non-randomised - controlled
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Blinding used |
Double blind | |||||||||||||||||||||||||||||||||||||||
Roles blinded |
Subject, Investigator | |||||||||||||||||||||||||||||||||||||||
Arms
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Arm title
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Placebo | |||||||||||||||||||||||||||||||||||||||
Arm description |
Subjects who completed the double-blind treatment period continued to receive JNJ-67953964 matching placebo capsules (2*1 placebo capsules) once daily during the withdrawal period for up to 2 weeks. | |||||||||||||||||||||||||||||||||||||||
Arm type |
Placebo | |||||||||||||||||||||||||||||||||||||||
Investigational medicinal product name |
Placebo
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Investigational medicinal product code |
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Other name |
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Pharmaceutical forms |
Capsule
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Routes of administration |
Oral use
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Dosage and administration details |
Matching placebo capsules (2*1 placebo capsules) were administered orally up to 2 weeks in withdrawal period.
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Baseline characteristics reporting groups
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Reporting group title |
Placebo
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Reporting group description |
Subjects with major depressive disorder (MDD) who had inadequate response to selective serotonin reuptake inhibitor /serotonin-norepinephrine reuptake inhibitor (SSRI/SNRI) treatment received JNJ-67953964 matching placebo capsules (2*1 placebo capsules) once daily starting from Day 2 to 3 weeks in lead-in period in addition to SSRI/SNRI treatment. | ||||||||||||||||||||||||||||||||||||
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End points reporting groups
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Reporting group title |
Placebo
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Reporting group description |
Subjects with major depressive disorder (MDD) who had inadequate response to selective serotonin reuptake inhibitor /serotonin-norepinephrine reuptake inhibitor (SSRI/SNRI) treatment received JNJ-67953964 matching placebo capsules (2*1 placebo capsules) once daily starting from Day 2 to 3 weeks in lead-in period in addition to SSRI/SNRI treatment. | ||
Reporting group title |
Placebo
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Reporting group description |
Subjects who were responders or non-responders to lead-in placebo group were re-randomized to receive JNJ-67953964 matching placebo capsules (2*1 placebo capsules) once daily during double-blind treatment period (up to 6 weeks after lead-in period) in addition to SSRI/SNRI treatment. | ||
Reporting group title |
JNJ-67953964 10 milligrams (mg)
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Reporting group description |
Subjects who were responders or non-responders to lead-in placebo group were re-randomized to receive 10 mg JNJ-67953964 capsules (2*5 mg JNJ-67953964 capsules) once daily during double-blind treatment period (up to 6 weeks after lead-in period) in addition to SSRI/SNRI treatment. | ||
Reporting group title |
Placebo
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Reporting group description |
Subjects who completed the double-blind treatment period continued to receive JNJ-67953964 matching placebo capsules (2*1 placebo capsules) once daily during the withdrawal period for up to 2 weeks. |
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End point title |
Change from Treatment Baseline in Montgomery Asberg Depression Rating Scale (MADRS) Total Score at Treatment Week 6 in Non-Responders during Placebo Lead-in Period | ||||||||||||
End point description |
The MADRS is a clinician-rated scale designed to measure depression severity and detects changes due to antidepressant treatment. The scale 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), summed for a total possible score of 60. Higher scores represent a more severe condition. The MADRS evaluates apparent sadness, reported sadness, inner tension, sleep appetite, concentration, lassitude, inability to feel (interest level), pessimistic thoughts, and suicidal thoughts. Negative change from baseline indicates improvement. The enriched intent-to-treat (eITT) analysis set included all enrolled lead-in placebo non-responders who were randomized into a treatment period, received at least 1 dose of study medication, and had at least 1 post-baseline MADRS assessment during the treatment period. Here 'N' (number of subjects analyzed) includes the number of subjects evaluable for this endpoint.
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End point type |
Primary
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End point timeframe |
Treatment Baseline and Treatment Week 6
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Statistical analysis title |
Statistical Analysis | ||||||||||||
Comparison groups |
Placebo v JNJ-67953964 10 milligrams (mg)
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Number of subjects included in analysis |
118
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Analysis specification |
Pre-specified
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Analysis type |
superiority | ||||||||||||
P-value |
= 0.0443 | ||||||||||||
Method |
Mixed models analysis | ||||||||||||
Parameter type |
Least Squares Mean Difference | ||||||||||||
Point estimate |
-2.1
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Confidence interval |
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level |
80% | ||||||||||||
sides |
1-sided
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lower limit |
- | ||||||||||||
upper limit |
-1.09 | ||||||||||||
Variability estimate |
Standard error of the mean
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Dispersion value |
1.25
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End point title |
Change from Treatment Baseline in Montgomery Asberg Depression Rating Scale (MADRS) Total Score at Treatment Week 6 in Both Responders and Non-Responders during Placebo Lead-in Period | ||||||||||||
End point description |
The MADRS is a clinician-rated scale designed to measure depression severity and detects changes due to antidepressant treatment. The scale 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), summed for a total possible score of 60. Higher scores represent a more severe condition. The MADRS evaluates apparent sadness, reported sadness, inner tension, sleep appetite, concentration, lassitude, inability to feel (interest level), pessimistic thoughts, and suicidal thoughts. Negative change from baseline indicates improvement. The full intent-to-treat (fITT) analysis set included all enrolled subjects who were randomized into a treatment period, received at least 1 dose of study medication, and had at least 1 post-treatment baseline assessment of MADRS during the treatment period. Here 'N' (number of subjects analyzed) includes the number of subjects evaluable for this endpoint.
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End point type |
Secondary
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End point timeframe |
Treatment Baseline and Treatment Week 6
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Statistical analysis title |
Statistical Analysis | ||||||||||||
Comparison groups |
Placebo v JNJ-67953964 10 milligrams (mg)
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Number of subjects included in analysis |
158
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Analysis specification |
Pre-specified
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Analysis type |
superiority | ||||||||||||
P-value |
= 0.0017 | ||||||||||||
Method |
Mixed models analysis | ||||||||||||
Parameter type |
Least Squares Mean Difference | ||||||||||||
Point estimate |
-3.1
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Confidence interval |
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level |
80% | ||||||||||||
sides |
1-sided
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lower limit |
- | ||||||||||||
upper limit |
-2.21 | ||||||||||||
Variability estimate |
Standard error of the mean
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Dispersion value |
1.05
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End point title |
Number of Subjects with Treatment-emergent Adverse Events (TEAEs) during Treatment Period | |||||||||
End point description |
An AE can be any unfavorable and unintended sign (including an abnormal finding), symptom, or disease temporally associated with the use of a medicinal (investigational or non investigational) product, whether or not related to that medicinal (investigational or non investigational) product. TEAEs were AEs with onset during the treatment phase that has worsened since baseline. The full safety analysis set included all enrolled subjects who received at least 1 dose of study medication in the treatment period.
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End point type |
Secondary
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End point timeframe |
Up to Week 9
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No statistical analyses for this end point |
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End point title |
Change from Treatment Baseline in Snaith-Hamilton Pleasure Scale (SHAPS) Total Score at Treatment Week 6 | ||||||||||||
End point description |
The SHAPS is a self-reported 14-item, instrument, developed for the assessment of hedonic capacity. Subjects score whether they experience pleasure in performing a list of activities or experiences. Subjects can rate the answers as 1-4 where 1 indicates “Definitely agree”, 2 indicates “Agree”, 3 indicates “Disagree” and 4 indicates “Definitely disagree”. The subject's item responses are summed to provide a total score ranging from 14 to 56. A higher total SHAPS score indicates higher levels of current anhedonia. Negative change from baseline indicates improvement. The eITT analysis set included all enrolled lead-in placebo non-responders who were randomized into a treatment period, received at least 1 dose of study medication, and had at least 1 post-baseline MADRS assessment during the treatment period. Here 'N' (number of subjects analyzed) includes the number of subjects evaluable for this endpoint.
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End point type |
Secondary
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End point timeframe |
Treatment Baseline and Treatment Week 6
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Statistical analysis title |
Statistical Analysis | ||||||||||||
Comparison groups |
Placebo v JNJ-67953964 10 milligrams (mg)
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Number of subjects included in analysis |
118
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Analysis specification |
Pre-specified
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Analysis type |
superiority | ||||||||||||
P-value |
= 0.4188 | ||||||||||||
Method |
Mixed models analysis | ||||||||||||
Parameter type |
Least Squares Mean Difference | ||||||||||||
Confidence interval |
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level |
80% | ||||||||||||
sides |
1-sided
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lower limit |
- | ||||||||||||
upper limit |
0.41 | ||||||||||||
Variability estimate |
Standard error of the mean
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Dispersion value |
0.87
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End point title |
Change from Treatment Baseline in Clinical Global Impression - Severity (CGI-S) Total Score at Treatment Week 6 | ||||||||||||
End point description |
CGI-S provides an overall clinician-determined summary measure of severity of subject’s illness that considers all available information, including knowledge of subject’s history, psychosocial circumstances, symptoms, behavior, and impact of symptoms on subject’s ability to function. CGI-S evaluates severity of psychopathology on scale of 0 to 7. Subject is assessed on severity of mental illness at time of rating according to: 0=not assessed; 1=normal (not at all ill); 2=borderline mentally ill; 3=mildly ill; 4=moderately ill; 5=markedly ill; 6=severely ill; 7=among most extremely ill patients. Negative change in score indicates improvement. eITT analysis set included all enrolled lead-in placebo non-responders who were randomized into a treatment period, received at least 1 dose of study medication, had at least 1 post-baseline MADRS assessment during treatment period. Here 'N' (number of subjects analyzed) includes number of subjects evaluable for this endpoint.
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End point type |
Secondary
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End point timeframe |
Treatment Baseline and Treatment Week 6
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No statistical analyses for this end point |
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End point title |
Change from Treatment Baseline in Symptoms of Major Depressive Disorder Scale (SMDDS) Total Score at Treatment Week 6 | ||||||||||||
End point description |
The SMDDS is a 16-item patient reported outcome (PRO) measure. Each item was rated by the subject according to a 5-point Likert scale. Subjects respond to each question using a rating scale between 0 ("Not at all" or "Never") to 4 ("Extremely" or "Always"). The total score ranges from 0 to 60. The SMDDS uses a 7-day recall period and verbal rating scales. Higher score indicates more severe depressive symptomatology. Negative change from baseline indicates improvement. The eITT analysis set included all enrolled lead-in placebo non-responders who were randomized into a treatment period, received at least 1 dose of study medication, and had at least 1 post-baseline MADRS assessment during the treatment period. Here 'N' (number of subjects analyzed) includes the number of subjects evaluable for this endpoint.
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End point type |
Secondary
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End point timeframe |
Treatment Baseline and Treatment Week 6
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No statistical analyses for this end point |
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End point title |
Number of Subjects with Self-Assessment of Treatment Experience (SATE) Score at Treatment Week 6 | ||||||||||||||||||||||||||||||||||||
End point description |
SATE questionnaire is a 1- or 2-item self-reported scale designed to provide additional information regarding subject’s subjective experience while taking treatment. This was internal Janssen questionnaire and questions were asked to subject weekly by the Q1.6-app. For rating overall depression, subject selected one option out of Improved, not changed or got worse; for depression improvement, subject selected one option out of slightly improved, much improved, very much improved and for depression worsen subject selected slightly worse, much worse, very much worse. The eITT analysis set included all enrolled lead-in placebo non-responders who were randomized into a treatment period, received at least 1 dose of study medication, and had at least 1 post-baseline MADRS assessment during the treatment period. Here 'n' (number analyzed) included all subjects evaluable for specified categories.
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End point type |
Secondary
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End point timeframe |
Week 6
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No statistical analyses for this end point |
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End point title |
Change from Treatment Baseline in Hamilton Anxiety Scale 6 (HAM-A6) Total Score at Treatment Week 6 | ||||||||||||
End point description |
HAM-A scale assesses severity of different anxiety-related symptoms with a score range of 0 to 52. Higher score indicated severity in anxiety symptoms. Each of the 14 items is rated by clinician on a 5-point scale ranging from 0 (not present) to 4 (maximum degree). HAM-A6 is a uni-dimensional, 6-item subscale derived from HAM-A. HAM-A6 comprises of five psychic anxiety symptoms: anxious mood, psychic tension, fears, intellectual disturbances, and anxious behaviour observed at the interview, as well as one somatic item, muscular tension. HAM-A6 Subscale Score ranges from 0 to 24, with higher scores indicating greater severity of core symptoms. eITT analysis set included all enrolled lead-in placebo non-responders who were randomized into a treatment period, received at least 1 dose of study medication, and had at least 1 post-baseline MADRS assessment during the treatment period. Here 'N' (number of subjects analyzed) includes number of subjects evaluable for this endpoint.
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End point type |
Secondary
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End point timeframe |
Treatment Baseline and Treatment Week 6
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No statistical analyses for this end point |
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End point title |
Change from Treatment Baseline in Structured Interview Guide for the Hamilton Anxiety Rating Scale (SIGH-A) Score at Treatment Week 6 | ||||||||||||
End point description |
SIGH-A is a 14-item scale to measure severity of different anxiety-related symptoms in subjects. Each of the 14 items is rated by the clinician on a 5-point scale ranging from 0 (not present) to 4 (maximum degree) with a total score range of 0 to 56 where higher score indicates worsening. The eITT analysis set included all enrolled lead-in placebo non-responders who were randomized into a treatment period, received at least 1 dose of study medication, and had at least 1 post-baseline MADRS assessment during the treatment period. Here 'N' (number of subjects analyzed) includes the number of subjects evaluable for this endpoint.
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End point type |
Secondary
|
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End point timeframe |
Treatment Baseline and Treatment Week 6
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No statistical analyses for this end point |
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End point title |
Maximum Plasma Concentration (Cmax) of JNJ-67953964 | ||||||||||||||
End point description |
Cmax is defined as maximum plasma concentration of JNJ-67953964. eITT population included all enrolled lead-in placebo non-responders who were randomized into a treatment period, received at least 1 dose of study medication, and had at least 1 post-baseline MADRS assessment during the treatment period. Here 'N' (number of subjects analyzed) includes the number of subjects evaluable for this endpoint. Here 'n' (number analyzed) included all subjects evaluable for specified time point categories.
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End point type |
Secondary
|
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End point timeframe |
Week 1, 3 and 6
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No statistical analyses for this end point |
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Adverse events information
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Timeframe for reporting adverse events |
Up to Week 9
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Adverse event reporting additional description |
Safety analysis set included all enrolled subjects who received at least 1 dose of study drug in treatment period. As planned, AEs were collected only during double blind treatment phase when study drug JNJ-67953964 was administered to randomized subjects. No AEs collected during Lead-in and Withdrawal period as subjects received only placebo.
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Assessment type |
Non-systematic | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Dictionary used for adverse event reporting
|
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Dictionary name |
MedDRA | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Dictionary version |
22.1
|
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Reporting groups
|
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Reporting group title |
Placebo
|
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Reporting group description |
Subjects who were responders or non-responders to lead-in placebo group were re-randomized to receive JNJ-67953964 matching placebo capsules (2*1 placebo capsules) once daily during double blind treatment period (up to 6 weeks after lead-in period) in addition to SSRI/SNRI treatment. | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting group title |
JNJ-67953964 10 milligrams (mg)
|
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Reporting group description |
Subjects who were responders or non-responders to lead-in placebo group were re-randomized to receive 10 mg JNJ-67953964 capsules (2*5 mg JNJ-67953964 capsules) once daily during double-blind treatment period (up to 6 weeks after lead-in period) in addition to SSRI/SNRI treatment. | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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Frequency threshold for reporting non-serious adverse events: 5% | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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|
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Substantial protocol amendments (globally) |
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Were there any global substantial amendments to the protocol? Yes | |||
Date |
Amendment |
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18 Jun 2018 |
Amendment INT-1 was substantial amendment and the overall reason for the amendment was to harmonize with procedures of some vendors, to update dosing instructions, and to correct typographical errors. |
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26 Feb 2019 |
Amendment INT-2 was substantial amendment and the overall reason for the amendment was to add the EudraCT number, to change inclusion criterion on female sterilization, to change exclusion criteria on concomitant medication (due to reconsideration of current clinical practices), and to implement a few changes requested by clinical sites. |
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28 Aug 2019 |
Amendment INT-3 was substantial amendment and the overall reason for the amendment was to harmonize aspects of local amendments (GBR-1 and GER-1) into one common protocol, to include corrections already documented in note-to-files, and to include some administrative corrections. |
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Interruptions (globally) |
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Were there any global interruptions to the trial? No | |||
Limitations and caveats |
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Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data. | |||
None reported |