- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02498392
An Efficacy, Safety and Tolerability Study of JNJ-42165279 in Participants With Major Depressive Disorder With Anxious Distress
November 9, 2022 updated by: Janssen Research & Development, LLC
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 With Anxious Distress
The purpose of this study is to evaluate the efficacy and safety and tolerability of JNJ-42165279 in participants with major depressive disorder (MDD) with anxiety symptoms who have had inadequate response to treatment with a selective serotonin reuptake inhibitor (SSRI) or serotonergic/noradrenergic reuptake inhibitor (SNRI).
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
This is a multicenter, double-blind (neither physician nor participant knows the treatment that the participant receives), placebo-controlled, randomized, parallel-group study in participants with Major Depressive Disorder (MDD) with Anxious Distress.
Participants who had treatment initiated with a SSRI/SNRI allowed by the protocol will be evaluated at the investigation site.
The site assessment will be reviewed and validated by an independent central rater.
The review will include the clinical history of MDD, SSRI/SNRI treatment of adequate dose and duration for the current episode of depression, and current symptom severity on the Hamilton Depression Rating Scale (HDRS17).
Enrolled participants will be maintained on SSRI/SNRI treatment throughout the study to determine whether additional treatment with JNJ-4216579 can reduce the symptoms of MDD with anxious distress.The study will consist of 3 phases: a Screening Phase of up to 4 weeks, an 11-week double-blind Treatment Phase, and a 3-week post-treatment (follow up) Phase.
The double-blind treatment Phase of the trial will consist of 3 periods.
The first period is a placebo lead-in of double-blind duration, after which participants will enter the treatment period when they will be randomly assigned to JNJ-42165279 or continuation on placebo for 6 weeks.
Participants who successfully complete the treatment period prior to the end of Week 11, will be treated with placebo for the remaining time of the double-blind phase of the study, which will vary depending on the duration of the placebo lead-in for the specific participant.
The total study duration for each participant will be approximately 18 weeks.
Efficacy and safety of JNJ-42165279 will be evaluated.
Participants' safety will be monitored throughout the study.
Study Type
Interventional
Enrollment (Actual)
161
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Chisinau, Moldova, Republic of
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Ekaterinburg, Russian Federation
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Orenburg, Russian Federation
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Saratov, Russian Federation
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St-Petersburg, Russian Federation
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Tomsk, Russian Federation
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Alicante, Spain
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Barcelona, Spain
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Bilbao, Spain
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Sant Boi de Llobregat, Spain
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Zamora, Spain
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Glevakha, Ukraine
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Kharkiv, Ukraine
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Kherson, Ukraine
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Kyiv, Ukraine
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Lviv, Ukraine
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Smila, Ukraine
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Uzhgorod, Ukraine
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Barnsley, United Kingdom
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Blackpool, United Kingdom
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Liverpool, United Kingdom
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Manchester, United Kingdom
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South Staffordshire, United Kingdom
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Stourton, United Kingdom
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California
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Costa Mesa, California, United States
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Oceanside, California, United States
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Florida
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Miami, Florida, United States
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Massachusetts
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Natick, Massachusetts, United States
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New York
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Cedarhurst, New York, United States
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North Carolina
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Raleigh, North Carolina, United States
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Pennsylvania
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Allentown, Pennsylvania, United States
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Utah
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Salt Lake City, Utah, United States
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 64 years (ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Participant must meet the Diagnostic and Statistical Manual of Mental Disorders-IV (DSM-IV) or 5 diagnostic criteria for major depressive disorder (MDD) with Anxious Distress
- Participants with a diagnosis of comorbid Generalized Anxiety Disorder, Social Anxiety Disorder, or Panic Disorder may be included, if the investigator considers MDD with Anxious Distress to be the primary diagnosis (confirmed by an independent central rater at screening)
- Participants must have been treated with an approved SSRI/SNRI antidepressants for at least 6 continuous weeks, validated by an independent central rater contracted by the sponsor
- A 17-item Hamilton Depression Rating Scale (HDRS17) total score greater than or equal to (>=)18 and a HDRS17 anxiety/somatization factor score >=7 at screening, assessed by a site rater and reviewed by an independent central rater on Day 1
- Participant must be willing and able to adhere to the prohibitions and restrictions
- Participant Body mass index (BMI = weight/height2) must be between 18 and 35 kilogram per square meter (kg/m^2) inclusive
Exclusion Criteria:
- Has other psychiatric condition, including, but not limited to, MDD with psychotic features, bipolar disorder, obsessive-compulsive disorder, post-traumatic stress disorder, borderline personality disorder, eating disorder, or schizophrenia
- Has a length of current Major Depressive Episode (MDE) greater than (>) 6 months
- Has more than 1 failed antidepressant treatment of adequate dose and duration in the current MDE, Not including the inadequate response to the current selective serotonin reuptake inhibitor (SSRI) or serotonergic/noradrenergic reuptake inhibitor (SNRI) antidepressant
- Has initiated psychotherapy specific for MDD (such as cognitive behavioral, behavioral, or interpersonal therapy) for the current episode of depression within 6 weeks prior to Screening
- Has a current or recent history of clinically significant suicidal ideation within the past 6 months, or a history of suicidal behavior within the past year
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: DOUBLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
PLACEBO_COMPARATOR: Responders-Placebo
Participants who responded in the placebo lead-in period will be administered with Matching Placebo orally.
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Matching Placebo will be administered orally.
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EXPERIMENTAL: Responders-JNJ-42165279
Participants who responded in the placebo lead-in period will be administered with JNJ-42165279 orally at a dose of 25 milligrams (mg) tablets once daily for 6 weeks.
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JNJ-42165279 will be administered orally at a dose of 25 milligrams (mg) tablet once daily for 6 weeks.
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PLACEBO_COMPARATOR: Non Responders-Placebo
Participants who did not respond in the placebo lead-in period will be administered with Matching Placebo orally.
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Matching Placebo will be administered orally.
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EXPERIMENTAL: Non Responders-JNJ-42165279
Participants who did not respond in the placebo lead-in period will be administered with JNJ-42165279 orally at a dose of 25 mg tablets once daily for 6 weeks.
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JNJ-42165279 will be administered orally at a dose of 25 milligrams (mg) tablet once daily for 6 weeks.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Double-blind Treatment Period: Change From Baseline in Hamilton Depression Rating Scale (HDRS17) Total Score at Week 6 (eITT Population)
Time Frame: Baseline and Week 6
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HDRS17 is clinician-administered rating scale designed to assess severity of symptoms in participants 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.
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Baseline and Week 6
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Double-blind Treatment Period: Change From Baseline in HDRS17 Total Score at Week 6 (fITT Population)
Time Frame: Baseline and Week 6
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HDRS17 is a clinician-administered rating scale designed to assess severity of symptoms in participants 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.
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Baseline and Week 6
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Double-blind Treatment Period: Change From Baseline in Hamilton Anxiety Rating Subscale (HAM-A6) Score at Week 6 (eITT Population)
Time Frame: Baseline and Week 6
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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).
Each of the 6 items is rated by the clinician on a 5-point scale ranging from 0 (not present) to 4 (maximum degree).
The HAM-A6 score was calculated by summing the 6 item scores, and ranges from 0 to 24.
Higher scores indicated greater severity of symptoms.
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Baseline and Week 6
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Double-blind Treatment Period: Change From Baseline in HAM-A6 Score at Week 6 (fITT Population)
Time Frame: Baseline and Week 6
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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).
Each of the 6 items is rated by the clinician on a 5-point scale ranging from 0 (not present) to 4 (maximum degree).
The HAM-A6 score was calculated by summing the 6 item scores, and ranges from 0 to 24.
Higher scores indicated greater severity of symptoms.
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Baseline and Week 6
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Double-blind Treatment Period: Change From Baseline in Hamilton Depression Rating Subscale (HAM-D6) Score at Week 6 (eITT Population)
Time Frame: Baseline and Week 6
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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 pain), rated on a 5-point scale, where 0 = not present, and 1-4 represent increasingly severe symptoms.
Each of these items is rated by the clinician on either a 3-point (0 to 2) or a 5-point scale (0 to 4).
The point scale used a rating of 0 (absent), 1 (doubtful to mild), 2 (mild to moderate), 3 (moderate to severe), and 4 (very severe).
General somatic is scored 0 to 2 and all others are scored 0 to 4. 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.
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Baseline and Week 6
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Double-blind Treatment Period: Change From Baseline in HAM-D6 Score at Week 6 (fITT Population)
Time Frame: Baseline and Week 6
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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 somatic symptoms (tiredness and pain), rated on a 5-point scale, where 0 = not present, and 1-4 represent increasingly severe symptoms.
Each of these items is rated by the clinician on either a 3-point (0 to 2) or a 5-point scale (0 to 4).
The point scale used a rating of 0 (absent), 1 (doubtful to mild), 2 (mild to moderate), 3 (moderate to severe), and 4 (very severe).
General somatic is scored 0 to 2 and all others are scored 0 to 4. 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.
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Baseline and Week 6
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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)
Time Frame: Baseline and Week 6
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The SIGH-A was included as a means to determine the frequency and severity of signs and symptoms of anxiety; and determine both their influence on treatment and their responsiveness to treatment.
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.
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Baseline and Week 6
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Double-blind Treatment Period: Change From Baseline in SIGH-A Total Score at Week 6 (fITT Population
Time Frame: Baseline and Week 6
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The SIGH-A was included as a means to determine the frequency and severity of signs and symptoms of anxiety; and determine both their influence on treatment and their responsiveness to treatment.
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.
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Baseline and Week 6
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Double-blind Treatment Period: Change From Baseline in the HDRS17 Anxiety/Somatization Factor Total Score at Week 6 (eITT Population)
Time Frame: Baseline and Week 6
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The HDRS17 anxiety/somatization factor derived from Cleary and Guy's factor analysis of the HDRS17 scale, includes six items from the original 17-item version: 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.
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Baseline and Week 6
|
Double-blind Treatment Period: Change From Baseline in the HDRS17 Anxiety/Somatization Factor Total Score at Week 6 (fITT Population)
Time Frame: Baseline and Week 6
|
The HDRS17 anxiety/somatization factor derived from Cleary and Guy's factor analysis of the HDRS17 scale, includes six items from the original 17-item version: 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.
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Baseline and Week 6
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Double-blind Treatment Period: Percentage of Participants With Greater Than or Equal to (>=) 30 Percent (%) Improvement on the HDRS17 Total Score at Week 6 (eITT Population)
Time Frame: Week 6
|
Percentage of participants who had >=30% improvement (responders) on HDRS17 total score at Week 6 were reported.
HDRS17 is clinician-administered rating scale designed to assess severity of symptoms in participants 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.
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Week 6
|
Double-blind Treatment Period: Percentage of Participants With >= 30 % Improvement on the HDRS17 Total Score at Week 6 (fITT Population)
Time Frame: Week 6
|
Percentage of participants who had >=30% improvement (responders) on HDRS17 total score at Week 6 was reported.
HDRS17 is clinician-administered rating scale designed to assess severity of symptoms in participants 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.
|
Week 6
|
Double-blind Treatment Period: Percentage of Participants With >= 50% Improvement in the HDRS17 Total Score at Week 6 (eITT Population)
Time Frame: Week 6
|
Percentage of participants who had >=50% improvement (responders) in HDRS17 total score at Week 6 were reported.
HDRS17 is clinician-administered rating scale designed to assess severity of symptoms in participants 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.
|
Week 6
|
Double-blind Treatment Period: Percentage of Participants With >= 50% Improvement in the HDRS17 Total Score at Week 6 (fITT Population)
Time Frame: Week 6
|
Percentage of participants who had >=50% improvement (responders) in HDRS17 total score at Week 6 were reported.
HDRS17 is clinician-administered rating scale designed to assess severity of symptoms in participants 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.
|
Week 6
|
Double-blind Treatment Period: Percentage of Participants With >= 30% Improvement on SIGH-A Total Score at Week 6 (eITT Population)
Time Frame: Week 6
|
The SIGH-A was included as a means to determine the frequency and severity of signs and symptoms of anxiety and determine both their influence on treatment and their responsiveness to treatment.
The percentage of participants who had >= 30% improvement (responders) 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.
|
Week 6
|
Double-blind Treatment Period: Percentage of Participants With >= 30% Improvement on SIGH-A Total Score at Week 6 (fITT Population)
Time Frame: Week 6
|
The SIGH-A was included as a means to determine the frequency and severity of signs and symptoms of anxiety and determine both their influence on treatment and their responsiveness to treatment.
The percentage of participants who had >= 30% improvement (responders) 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.
|
Week 6
|
Double-blind Treatment Period: Percentage of Participants With >= 50% Improvement on SIGH-A Total Score at Week 6 (eITT Population)
Time Frame: Week 6
|
The SIGH-A was included as a means to determine the frequency and severity of signs and symptoms of anxiety and determine both their influence on treatment and their responsiveness to treatment.
The percentage of participants who had >= 50% improvement (responders) 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.
|
Week 6
|
Double-blind Treatment Period: Percentage of Participants With >= 50% Improvement on SIGH-A Total Score at Week 6 (fITT Population)
Time Frame: Week 6
|
The SIGH-A was included as a means to determine the frequency and severity of signs and symptoms of anxiety and determine both their influence on treatment and their responsiveness to treatment.
The percentage of participants who had >= 50% improvement (responders) 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.
|
Week 6
|
Double-blind Treatment Period: Percentage of Participants With Remission as Assessed by HDRS17 Total Score Less Than or Equal to (<=) 7 at Week 6 (eITT Population)
Time Frame: Week 6
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Percentage of participants with HDRS17 total score <= 7 were considered as remitters.
HDRS17 is clinician-administered rating scale designed to assess severity of symptoms in participants 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.
|
Week 6
|
Double-blind Treatment Period: Percentage of Participants With Remission as Assessed by HDRS17 Total Score <= 7 at Week 6 (fITT Population)
Time Frame: Week 6
|
Percentage of participants with HDRS17 total score <= 7 were considered as remitters.
HDRS17 is clinician-administered rating scale designed to assess severity of symptoms in participants 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.
|
Week 6
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Double-blind Treatment Period: Percentage of Participants With a Clinical Global Impression Improvement (CGI-I) Score of Very Much Improved or Much Improved at Week 6 (eITT Population)
Time Frame: Week 6
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The percentage of participants 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 participant'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.
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Week 6
|
Double-blind Treatment Period: Percentage of Participants With a Clinical Global Impression Improvement (CGI-I) Score of Very Much Improved or Much Improved at Week 6 (fITT Population)
Time Frame: Week 6
|
The percentage of participants 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 participant'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.
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Week 6
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Maximum Plasma Concentration (Cmax) of JNJ-42165279
Time Frame: Pre-dose, 2 to 4 hours post-dose on Days 14, 35, 63, and 77
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Cmax is defined as maximum plasma concentration of JNJ-42165279.
The data was pooled across visits at different timepoints to calculate Cmax.
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Pre-dose, 2 to 4 hours post-dose on Days 14, 35, 63, and 77
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Area Under the Plasma Concentration-time Curve From Zero to Dosing Intervals (AUC[0-tau]) of JNJ-42165279
Time Frame: Pre-dose, 2 to 4 hours post-dose on Days 14, 35, 63, and 77
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AUC(0-tau) is defined as area under the plasma concentration-time curve from 0 to t hours post dosing (time t is the dosing interval).
The data was pooled across visits at different timepoints to calculate AUC(0-tau).
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Pre-dose, 2 to 4 hours post-dose on Days 14, 35, 63, and 77
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Time to Reach the Maximum Plasma Concentration (Tmax) of JNJ-42165279
Time Frame: Pre-dose, 2 to 4 hours post-dose on Days 14, 35, 63, and 77
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Tmax is defined as time to reach the maximum plasma concentration of JNJ-42165279.
The data was pooled across visits at different timepoints to calculate Tmax.
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Pre-dose, 2 to 4 hours post-dose on Days 14, 35, 63, and 77
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (ACTUAL)
October 7, 2015
Primary Completion (ACTUAL)
February 4, 2019
Study Completion (ACTUAL)
February 4, 2019
Study Registration Dates
First Submitted
July 13, 2015
First Submitted That Met QC Criteria
July 13, 2015
First Posted (ESTIMATE)
July 15, 2015
Study Record Updates
Last Update Posted (ACTUAL)
November 10, 2022
Last Update Submitted That Met QC Criteria
November 9, 2022
Last Verified
November 1, 2022
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- CR107733
- 2015-002007-29 (EUDRACT_NUMBER)
- 42165279MDD2001 (OTHER: Janssen Research & Development, LLC)
Drug and device information, study documents
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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