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NCT00797966 · ClinicalTrials.gov registry record · Phase 2
Study of the Safety and Efficacy of OPC-34712 as Adjunctive Therapy in the Treatment of Patients With Major Depressive Disorder
A Phase 2 study, sponsored by Otsuka Pharmaceutical Development & Commercialization.
- Completed
- Registry status
- Phase 2
- Development phase
- 850
- Enrollment target
NCT00797966: Completed Phase 2 study, sponsored by Otsuka Pharmaceutical Development & Commercialization.
NCT00797966 is a Phase 2 study that has completed, run by Otsuka Pharmaceutical Development & Commercialization. The registered enrollment target is 850 participants, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (539% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00797966, a Phase 2 study, has completed, sponsored by Otsuka Pharmaceutical Development & Commercialization.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 850 participants
- Enrollment target
Study Summary
Primary: To compare the efficacy of OPC-34712 to placebo as adjunctive treatment to an assigned open-label marketed antidepressant treatment (ADT)in patients who demonstrate an incomplete response to a prospective eight week trial of the same assigned open-label marketed ADT.
Primary Outcome
The MADRS is utilized as the primary efficacy assessment of a participant's level of depression. 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 was unevaluable if less than 8 of the 10 items are recorded. If 8 or 9 of the 10 items were recorded, the MADRS Total Score was the mean of the recorded
Interventions
- DRUG Placebo
- DRUG ADT
- DRUG OPC-34712
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 850 participants |
| Start Date | 2009-05 |
| Est. Completion | 2010-07 |
| Phase | Phase 2 |
What the finished NCT00797966 record still lists
NCT00797966 is an interventional study that assigns participants to a tested intervention. The registered 850 participants enrollment target is mid-sized for trials with a published cap, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (539% higher).
The record links to 0 conditions, and to 3 interventions - of which Placebo is the first listed.
NCT00797966 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00797966 about?
NCT00797966 is a clinical study titled "Study of the Safety and Efficacy of OPC-34712 as Adjunctive Therapy in the Treatment of Patients With Major Depressive Disorder". Primary: To compare the efficacy of OPC-34712 to placebo as adjunctive treatment to an assigned open-label marketed antidepressant treatment (ADT)in patients who demonstrate an incomplete response to a prospective eight week trial of the same assigned open-label marketed ADT.
What is the current status of trial NCT00797966?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 850 participants. The study started on 2009-05. Estimated completion is 2010-07.
What interventions are being tested in trial NCT00797966?
The interventions under investigation include: Placebo (DRUG), ADT (DRUG), OPC-34712 (DRUG).
Who is sponsoring clinical trial NCT00797966?
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 NCT00797966's enrollment target sits among peer trials
850 35th of 2000 higher than 1,965 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 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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