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NCT01360645 · ClinicalTrials.gov registry record · Phase 3
Study of the Safety and Efficacy of Fixed Dose OPC-34712 as Adjunctive Therapy in the Treatment of Adults With Major Depressive Disorder (the Pyxis Trial)
A Phase 3 study, sponsored by Otsuka Pharmaceutical Development & Commercialization.
- Completed
- Registry status
- Phase 3
- Development phase
- 826
- Enrollment target
NCT01360645: Completed Phase 3 study, sponsored by Otsuka Pharmaceutical Development & Commercialization.
NCT01360645 is a Phase 3 study that has completed, run by Otsuka Pharmaceutical Development & Commercialization. The registered enrollment target is 826 participants, roughly in line with the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01360645, a Phase 3 study, has completed, sponsored by Otsuka Pharmaceutical Development & Commercialization.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 826 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 consists 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 is the sum of ratings for all 10 items. The possible total scores are from 0 to 60. The MADRS total score will be un-evaluable if less than 8 of the 10 items are recorded. If 8 or 9 of the 10 items are recorded, the MADRS total score will be the mean of the recorded items multiplied by 10 and then rounded to the first decimal place.
Interventions
- DRUG Placebo + ADT
- DRUG OPC-34712 + ADT
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 826 participants |
| Start Date | 2011-07 |
| Est. Completion | 2013-06 |
| Phase | Phase 3 |
What the finished NCT01360645 record still lists
NCT01360645 is an interventional study that assigns participants to a tested intervention. The registered 826 participants enrollment target is mid-sized for trials with a published cap, roughly in line with the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target.
The record links to 0 conditions, and to 2 interventions - of which Placebo + ADT is the first listed.
NCT01360645 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01360645 about?
NCT01360645 is a clinical study titled "Study of the Safety and Efficacy of Fixed Dose OPC-34712 as Adjunctive Therapy in the Treatment of Adults With Major Depressive Disorder (the Pyxis 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 NCT01360645?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 826 participants. The study started on 2011-07. Estimated completion is 2013-06.
What interventions are being tested in trial NCT01360645?
The interventions under investigation include: Placebo + ADT (DRUG), OPC-34712 + ADT (DRUG).
Who is sponsoring clinical trial NCT01360645?
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 NCT01360645's enrollment target sits among peer trials
826 400th of 2000 higher than 1,601 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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