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NCT03559192 · ClinicalTrials.gov registry record · Phase 2
A Study to Explore the Efficacy of JNJ-67953964 in the Treatment of Depression
A Phase 2 study of Depressive Disorder, Major, sponsored by Janssen Research & Development.
- Completed
- Registry status
- Phase 2
- Development phase
- 181
- Enrollment target
- 20
- Study locations
NCT03559192: Completed Phase 2 study of Depressive Disorder, Major, sponsored by Janssen Research & Development.
NCT03559192 is a Phase 2 study of Depressive Disorder, Major that has completed, run by Janssen Research & Development. The registered enrollment target is 181 participants, below the 239-participant average among 52 other Depressive Disorder, Major trials with a reported enrollment target (24% lower). The trial reports 20 study locations across 10 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03559192, a Phase 2 study of Depressive Disorder, Major, has completed, sponsored by Janssen Research & Development.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 181 participants
- Enrollment target
- 20
- Study locations
Study Summary
The purpose of this study is to evaluate the efficacy of JNJ-67953964 compared to placebo when administered as adjunctive treatment in participants with Major Depressive Disorder (MDD) partially responsive to selective serotonin reuptake inhibitor/ serotonin-norepinephrine reuptake inhibitor (SSRI/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.
Primary Outcome
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 (in
Conditions Studied
Interventions
- DRUG Placebo
- DRUG JNJ-67953964
Study Locations (20)
California
- Behavioral Research Specialists LLC - Glendale
- NRC Research Institute - Orange
- Artemis Institute for Clinical Research - Riverside
- Artemis Institute for Clinical Research - San Marcos
- Pacific Clinical Research Medical Group - Upland
Florida
- Innova Clinical Trials - Miami
- Galiz Research - Miami Springs
- APG Research LLC - Orlando
- Olympian Clinical Research - Tampa
- Meridien Research - Tampa
Illinois
- Chicago Research Center - Chicago
- Psychiatric Medicine Associates LLC - Skokie
New York
- Integrative Clinical Trials LLC - Brooklyn
- Richmond Behavioural Associates - Staten Island
Arizona
- Noble Clinical Research - Tucson
Arkansas
- Preferred Research Partners - Little Rock
Georgia
- Atlanta Behavioral Research, LLC - Atlanta
Louisiana
- Lake Charles Clinical Trials - Lake Charles
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 181 participants |
| Start Date | 2018-07-16 |
| Est. Completion | 2020-05-06 |
| Phase | Phase 2 |
What the finished NCT03559192 record still lists
NCT03559192 is an interventional study that assigns participants to a tested intervention. The registered 181 participants enrollment target is mid-sized for trials with a published cap, below the 239-participant average among 52 other Depressive Disorder, Major trials with a reported enrollment target (24% lower).
The record links to 1 condition, with Depressive Disorder, Major appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.
NCT03559192 names 20 study sites across 10 states, led by California, Florida, Illinois.
Frequently Asked Questions
What is clinical trial NCT03559192 about?
NCT03559192 is a clinical study titled "A Study to Explore the Efficacy of JNJ-67953964 in the Treatment of Depression". The purpose of this study is to evaluate the efficacy of JNJ-67953964 compared to placebo when administered as adjunctive treatment in participants with Major Depressive Disorder (MDD) partially responsive to selective serotonin reuptake inhibitor/ serotonin-norepinephrine reuptake inhibitor (SSRI/S...
What is the current status of trial NCT03559192?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 181 participants. The study started on 2018-07-16. Estimated completion is 2020-05-06.
What conditions does trial NCT03559192 study?
This clinical trial studies the following conditions: Depressive Disorder, Major.
What interventions are being tested in trial NCT03559192?
The interventions under investigation include: Placebo (DRUG), JNJ-67953964 (DRUG).
Who is sponsoring clinical trial NCT03559192?
This trial is sponsored by Janssen Research & Development, which has 593 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03559192 being conducted?
This trial has 20 study locations across Arizona, Arkansas, California, Florida, Georgia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT03559192's enrollment target sits among peer trials
181 23rd of 52 higher than 30 of 52 other Depressive Disorder, Major trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Depressive Disorder, Major trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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