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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 is a Phase 3 study that has completed, run by Otsuka Pharmaceutical Development & Commercialization. The registered enrollment target is 826 participants.
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
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01360645
The ClinicalTrials.gov registry entry for NCT01360645 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 826 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Otsuka Pharmaceutical Development & Commercialization, which has 221 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Placebo + ADT is the first listed.
NCT01360645 reports 0 study locations.
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.
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