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NCT04080752 · ClinicalTrials.gov registry record · Phase 2
A Study of JNJ-61393215 in the Treatment of Depression
A Phase 2 study of Major Depressive Disorder With Anxious Distress, sponsored by Janssen Research & Development.
- Completed
- Registry status
- Phase 2
- Development phase
- 222
- Enrollment target
- 20
- Study locations
NCT04080752: Completed Phase 2 study of Major Depressive Disorder With Anxious Distress, sponsored by Janssen Research & Development.
NCT04080752 is a Phase 2 study of Major Depressive Disorder With Anxious Distress that has completed, run by Janssen Research & Development. The registered enrollment target is 222 participants, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (67% higher). The trial reports 20 study locations across 8 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04080752, a Phase 2 study of Major Depressive Disorder With Anxious Distress, has completed, sponsored by Janssen Research & Development.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 222 participants
- Enrollment target
- 20
- Study locations
Study Summary
The purpose of this study is to evaluate the efficacy of JNJ-61393215 as adjunctive treatment compared to adjunctive placebo, as assessed by the change from baseline to week 6 on a 17-item Hamilton Depression Rating Scale (HDRS-17) in participants with major depressive disorder (MDD) with anxious distress with a score greater than or equal to (\>=) 2 on item 26 or 27 of the Inventory of Depressive Symptomatology, Clinician Rating -30 (IDS-C30), who have a suboptimal response to current treatment with a standard antidepressant.
Primary Outcome
Change from baseline in HDRS-17 total score at Week 6 was reported. The HDRS-17 is a clinician-administered rating scale designed to assess the severity of symptoms in participants diagnosed with depression with a score range of 0 to 52. Each of the 17 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). A total score (range: 0
Conditions Studied
Interventions
- DRUG Placebo
- DRUG JNJ-61393215
Study Locations (20)
Other
- ARENSIA - Chisinau
- City Clinical Psychiatric Hopsital 3 - Moscow
- Nizny Novgorod clinical psychiatric hospital 1 - Nizny Novgorod
- Orenburg Regional Clinical Psychiatric Hospital #1 - Orenburg
- Medical and Rehabilitation Research Center Phoenix - Rostov-on-Don
- Psychoneurological dispensary 10 - Saint Petersburg
- City Psychiatric hospital 7 named after I.P.Pavlov - Saint Petersburg
- Psychoneurological dispensary 1 - Saint Petersburg
- SHI 'Saratov City Clinical Hospital 2 n.a V.I. Razumovsky - Saratov
- Saratov Regional Psychiatric hospital named after St. Sofia - Saratov
- Engels psychiatric hospital - Saratov Region
Georgia
- Atlanta Institute - Alpharetta
- Atlanta Center for Medical Research - Atlanta
New York
- The Medical Research Network, LLC - New York
- Richmond Behavioural Associates - Staten Island
California
- Collaborative NeuroScience Network - Garden Grove
Ohio
- Ohio State University - Columbus
Oklahoma
- IPS Research Company - Oklahoma City
Pennsylvania
- Suburban Research Associates - Media
Texas
- UT Southwestern Medical Center - Dallas
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 222 participants |
| Start Date | 2019-09-17 |
| Est. Completion | 2021-09-02 |
| Phase | Phase 2 |
What the finished NCT04080752 record still lists
NCT04080752 is an interventional study that assigns participants to a tested intervention. The registered 222 participants enrollment target is mid-sized for trials with a published cap, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (67% higher).
The record links to 1 condition, with Major Depressive Disorder With Anxious Distress appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.
NCT04080752 names 20 study sites across 8 states, led by Other, Georgia, New York.
Frequently Asked Questions
What is clinical trial NCT04080752 about?
NCT04080752 is a clinical study titled "A Study of JNJ-61393215 in the Treatment of Depression". The purpose of this study is to evaluate the efficacy of JNJ-61393215 as adjunctive treatment compared to adjunctive placebo, as assessed by the change from baseline to week 6 on a 17-item Hamilton Depression Rating Scale (HDRS-17) in participants with major depressive disorder (MDD) with anxious di...
What is the current status of trial NCT04080752?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 222 participants. The study started on 2019-09-17. Estimated completion is 2021-09-02.
What conditions does trial NCT04080752 study?
This clinical trial studies the following conditions: Major Depressive Disorder With Anxious Distress.
What interventions are being tested in trial NCT04080752?
The interventions under investigation include: Placebo (DRUG), JNJ-61393215 (DRUG).
Who is sponsoring clinical trial NCT04080752?
This trial is sponsored by Janssen Research & Development, which has 593 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04080752 being conducted?
This trial has 20 study locations across California, Georgia, New York, Ohio, Oklahoma. 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 NCT04080752's enrollment target sits among peer trials
222 274th of 2000 higher than 1,726 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 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.
Source ClinicalTrials.gov registry export · 2026-08-08
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