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NCT01727726 · ClinicalTrials.gov registry record · Phase 3
A Study of Flexible-dose Brexpiprazole as Adjunctive Therapy in the Treatment of Adults With Major Depressive Disorder, the Delphinus Trial
A Phase 3 study, sponsored by Otsuka Pharmaceutical Development & Commercialization.
- Completed
- Registry status
- Phase 3
- Development phase
- 2,182
- Enrollment target
NCT01727726: Completed Phase 3 study, sponsored by Otsuka Pharmaceutical Development & Commercialization.
NCT01727726 is a Phase 3 study that has completed, run by Otsuka Pharmaceutical Development & Commercialization. The registered enrollment target is 2,182 participants, above the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (183% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01727726, a Phase 3 study, has completed, sponsored by Otsuka Pharmaceutical Development & Commercialization.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 2,182 participants
- Enrollment target
Study Summary
To compare the efficacy of brexpiprazole (flexible dose) with placebo as adjunctive therapy to an assigned open label antidepressant therapy (ADT) in the proposed subject population with MDD.
Primary Outcome
To determine the efficacy of brexpiprazole (flexible dose) with placebo as adjunctive therapy by assessment of MADRS total score. The MADRS depression rating scale was used to assess the subject's level of depression by utilizing the structured interview guide for the MADRS (SIGMA). The MADRS consisted of 10 items (apparent sadness, reported sadness, inner tension, reduced sleep, reduced appetite, concentration difficulties, lassitude, inability to feel, pessimistic thoughts and suicidal thought
Interventions
- DRUG Placebo
- DRUG Brexpiprazole
- DRUG Seroquel XR
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 2,182 participants |
| Start Date | 2012-12 |
| Est. Completion | 2016-11-10 |
| Phase | Phase 3 |
What the finished NCT01727726 record still lists
NCT01727726 is an interventional study that assigns participants to a tested intervention. Its 2,182 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 (183% higher).
The record links to 0 conditions, and to 3 interventions - of which Placebo is the first listed.
NCT01727726 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01727726 about?
NCT01727726 is a clinical study titled "A Study of Flexible-dose Brexpiprazole as Adjunctive Therapy in the Treatment of Adults With Major Depressive Disorder, the Delphinus Trial". To compare the efficacy of brexpiprazole (flexible dose) with placebo as adjunctive therapy to an assigned open label antidepressant therapy (ADT) in the proposed subject population with MDD.
What is the current status of trial NCT01727726?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 2,182 participants. The study started on 2012-12. Estimated completion is 2016-11-10.
What interventions are being tested in trial NCT01727726?
The interventions under investigation include: Placebo (DRUG), Brexpiprazole (DRUG), Seroquel XR (DRUG).
Who is sponsoring clinical trial NCT01727726?
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 NCT01727726's enrollment target sits among peer trials
2,182 95th of 2000 higher than 1,906 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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