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NCT01360632 · ClinicalTrials.gov registry record · Phase 3
Study of the Safety and Efficacy of Two Fixed Doses of OPC-34712 as Adjunctive Therapy in the Treatment of Adults With Major Depressive Disorder (the Polaris Trial)
A Phase 3 study, sponsored by Otsuka Pharmaceutical Development & Commercialization.
- Completed
- Registry status
- Phase 3
- Development phase
- 1,539
- Enrollment target
NCT01360632: Completed Phase 3 study, sponsored by Otsuka Pharmaceutical Development & Commercialization.
NCT01360632 is a Phase 3 study that has completed, run by Otsuka Pharmaceutical Development & Commercialization. The registered enrollment target is 1,539 participants, above the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (99% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01360632, a Phase 3 study, has completed, sponsored by Otsuka Pharmaceutical Development & Commercialization.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 1,539 participants
- Enrollment target
Study Summary
To compare the effect of OPC-34712 (brexpiprazole) to the effect of placebo (an inactive substance) as add on treatment to an assigned FDA approved antidepressant treatment (ADT) in patients with Major Depressive Disorder who demonstrate an incomplete response to a prospective trial of the same assigned FDA approved ADT
Primary Outcome
The MADRS was utilized as the primary efficacy assessment of a participant's level of depression. The MADRS consisted of 10 items, all rated on a 0 to 6 scale with 0 being the "best" rating and 6 being the "worst" rating. The MADRS total score were to be unevaluable if less than 8 of the 10 items were recorded. If 8 or 9 of the 10 items were recorded, the MADRS total score was the mean of the recorded items multiplied by 10 and then rounded of to the first decimal place. The MADRS Total Score is
Interventions
- DRUG Placebo + ADT
- DRUG OPC-34712 + ADT
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 1,539 participants |
| Start Date | 2011-06 |
| Est. Completion | 2013-09 |
| Phase | Phase 3 |
What the finished NCT01360632 record still lists
NCT01360632 is an interventional study that assigns participants to a tested intervention. Its 1,539 participants enrollment target places it among the larger protocols in the corpus, above the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (99% higher).
The record links to 0 conditions, and to 2 interventions - of which Placebo + ADT is the first listed.
NCT01360632 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01360632 about?
NCT01360632 is a clinical study titled "Study of the Safety and Efficacy of Two Fixed Doses of OPC-34712 as Adjunctive Therapy in the Treatment of Adults With Major Depressive Disorder (the Polaris Trial)". To compare the effect of OPC-34712 (brexpiprazole) to the effect of placebo (an inactive substance) as add on treatment to an assigned FDA approved antidepressant treatment (ADT) in patients with Major Depressive Disorder who demonstrate an incomplete response to a prospective trial of the same assi...
What is the current status of trial NCT01360632?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 1,539 participants. The study started on 2011-06. Estimated completion is 2013-09.
What interventions are being tested in trial NCT01360632?
The interventions under investigation include: Placebo + ADT (DRUG), OPC-34712 + ADT (DRUG).
Who is sponsoring clinical trial NCT01360632?
This trial is sponsored by Otsuka Pharmaceutical Development & Commercialization, which has 221 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01360632's enrollment target sits among peer trials
1,539 151st of 2000 higher than 1,850 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 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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