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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 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. The trial reports 20 study locations across 8 states.
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.
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 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04080752
The ClinicalTrials.gov registry entry for NCT04080752 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 222 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Janssen Research & Development, which has 593 total studies on file at ClinicalTrials.gov.
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 reports 20 study locations spanning 8 distinct geographic areas - top geographies include 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.
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