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NCT02196506 · ClinicalTrials.gov registry record · Phase 3
Study of the Safety and Efficacy of Fixed-dose Brexpiprazole (OPC-34712) as Adjunctive Therapy in the Treatment of Adults With Major Depressive Disorder With and Without Anxious Distress
A Phase 3 study of Depression and Depressive Disorder, Major, sponsored by Otsuka Pharmaceutical Development & Commercialization.
- Completed
- Registry status
- Phase 3
- Development phase
- 837
- Enrollment target
- 20
- Study locations
NCT02196506 is a Phase 3 study of Depression and Depressive Disorder, Major that has completed, run by Otsuka Pharmaceutical Development & Commercialization. The registered enrollment target is 837 participants, roughly in line with the 785-participant average among 679 other Depression trials with a reported enrollment target. The trial reports 20 study locations across 15 states.
The verdict
NCT02196506, a Phase 3 study of Depression and Depressive Disorder, Major, has completed, sponsored by Otsuka Pharmaceutical Development & Commercialization.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 837 participants
- Enrollment target
- 20
- Study locations
Study Summary
The purpose of this study is to assess the tolerability, safety, and efficacy of brexpiprazole (2.0 mg/day) as adjunctive therapy in adult subjects with a diagnosis of MDD with and without anxious distress
Conditions Studied
Interventions
- DRUG Placebo + ADT
- DRUG Brexpiprazole +ADT
Study Locations (20)
New York
- - Jamaica
- - New York
- - Staten Island
Florida
- - Hialeah
- - Orlando
Georgia
- - Alpharetta
- - Smyrna
Oregon
- - Portland
- - Salem
Alabama
- - Birmingham
California
- - Beverly Hills
Colorado
- - Denver
Maryland
- - Baltimore
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 837 participants |
| Start Date | 2014-07 |
| Est. Completion | 2016-05 |
| Phase | Phase 3 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02196506
The ClinicalTrials.gov registry entry for NCT02196506 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 837 participants, a figure that helps gauge the scale of data the investigators plan to collect, roughly in line with the 785-participant average among 679 other Depression trials with a reported enrollment target. The listed sponsor is Otsuka Pharmaceutical Development & Commercialization, which has 221 total studies on file at ClinicalTrials.gov.
The record links to 5 conditions, with Depression appearing as the primary indexed condition, and to 2 interventions - of which Placebo + ADT is the first listed.
NCT02196506 reports 20 study locations spanning 15 distinct geographic areas - top geographies include New York, Florida, Georgia.
Frequently Asked Questions
What is clinical trial NCT02196506 about?
NCT02196506 is a clinical study titled "Study of the Safety and Efficacy of Fixed-dose Brexpiprazole (OPC-34712) as Adjunctive Therapy in the Treatment of Adults With Major Depressive Disorder With and Without Anxious Distress". The purpose of this study is to assess the tolerability, safety, and efficacy of brexpiprazole (2.0 mg/day) as adjunctive therapy in adult subjects with a diagnosis of MDD with and without anxious distress
What is the current status of trial NCT02196506?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 837 participants. The study started on 2014-07. Estimated completion is 2016-05.
What conditions does trial NCT02196506 study?
This clinical trial studies the following conditions: Depression, Depressive Disorder, Major, Depressive Disorder, Mood Disorders, Mental Disorders.
What interventions are being tested in trial NCT02196506?
The interventions under investigation include: Placebo + ADT (DRUG), Brexpiprazole +ADT (DRUG).
Who is sponsoring clinical trial NCT02196506?
This trial is sponsored by Otsuka Pharmaceutical Development & Commercialization, which has 221 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT02196506 being conducted?
This trial has 20 study locations across Alabama, California, Colorado, Florida, Georgia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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