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NCT01072929 · ClinicalTrials.gov registry record · Phase 3
A Study to Evaluate the Efficacy and Safety of Armodafinil Treatment as Adjunctive Therapy in Adults With Major Depression Associated With Bipolar I Disorder
A Phase 3 study, sponsored by Cephalon.
- Completed
- Registry status
- Phase 3
- Development phase
- 433
- Enrollment target
NCT01072929 is a Phase 3 study that has completed, run by Cephalon. The registered enrollment target is 433 participants.
The verdict
NCT01072929, a Phase 3 study, has completed, sponsored by Cephalon.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 433 participants
- Enrollment target
Study Summary
The primary objective of the study is to determine whether armodafinil treatment, at a dosage of 150 mg/day, is more effective than placebo treatment as adjunctive therapy to mood stabilizers for treatment of adults with major depression associated with bipolar I disorder.
Interventions
- DRUG Placebo
- DRUG Armodafinil
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 433 participants |
| Start Date | 2010-01 |
| Est. Completion | 2012-03 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01072929
The ClinicalTrials.gov registry entry for NCT01072929 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 433 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Cephalon, which has 64 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT01072929 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01072929 about?
NCT01072929 is a clinical study titled "A Study to Evaluate the Efficacy and Safety of Armodafinil Treatment as Adjunctive Therapy in Adults With Major Depression Associated With Bipolar I Disorder". The primary objective of the study is to determine whether armodafinil treatment, at a dosage of 150 mg/day, is more effective than placebo treatment as adjunctive therapy to mood stabilizers for treatment of adults with major depression associated with bipolar I disorder.
What is the current status of trial NCT01072929?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 433 participants. The study started on 2010-01. Estimated completion is 2012-03.
What interventions are being tested in trial NCT01072929?
The interventions under investigation include: Placebo (DRUG), Armodafinil (DRUG).
Who is sponsoring clinical trial NCT01072929?
This trial is sponsored by Cephalon, which has 64 total clinical trials registered on ClinicalTrials.gov.
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