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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: Completed Phase 3 study of Depression and Depressive Disorder, Major, sponsored by Otsuka Pharmaceutical Development & Commercialization.
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. According to ClinicalTrials.gov, the official US trial registry.
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
Primary Outcome
To assess the change in the Montgomery-Asberg Depression Rating Scale (MADRS) Total Score from Baseline (End of Phase A \[Week 8\]) to Week 14. The MADRS was utilized as the primary efficacy assessment of the participant's level of depression and was administered utilizing the Structured Interview Guide for the MADRS (SIGMA). The MADRS consisted of 10 items each with 7 defined grades of severity. The rater decided whether the rating lied on predefined scale steps (0, 2, 4, 6) or between them (1,
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 |
What the finished NCT02196506 record still lists
NCT02196506 is an interventional study that assigns participants to a tested intervention. The registered 837 participants enrollment target is mid-sized for trials with a published cap, roughly in line with the 785-participant average among 679 other Depression trials with a reported enrollment target.
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 names 20 study sites across 15 states, led by 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.
Learn More About Clinical Trials
Similar trials for Depression
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 NCT02196506's enrollment target sits among peer trials
837 50th of 679 higher than 630 of 679 other Depression trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Depression 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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