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NCT01305408 · ClinicalTrials.gov registry record · Phase 3
Study to Evaluate the Efficacy and Safety of Armodafinil Treatment (150 mg/Day) 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
- 399
- Enrollment target
NCT01305408: Completed Phase 3 study, sponsored by Cephalon.
NCT01305408 is a Phase 3 study that has completed, run by Cephalon. The registered enrollment target is 399 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (48% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01305408, a Phase 3 study, has completed, sponsored by Cephalon.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 399 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.
Primary Outcome
The IDS-C30 is a standardized 30-item, clinician-rated scale to assess the severity of a participant's depressive symptoms. Every effort was made to have the same rater evaluate a participant across all visits. Total scores range from 0-84, with a score of 0 indicating no depression and a score of 84 indicating the most severe depression. Negative change from baseline values indicate improvement in the severity of depression.
Interventions
- DRUG Placebo
- DRUG Armodafinil
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 399 participants |
| Start Date | 2011-03 |
| Est. Completion | 2013-07 |
| Phase | Phase 3 |
What the finished NCT01305408 record still lists
NCT01305408 is an interventional study that assigns participants to a tested intervention. The registered 399 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (48% lower).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT01305408 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01305408 about?
NCT01305408 is a clinical study titled "Study to Evaluate the Efficacy and Safety of Armodafinil Treatment (150 mg/Day) 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 NCT01305408?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 399 participants. The study started on 2011-03. Estimated completion is 2013-07.
What interventions are being tested in trial NCT01305408?
The interventions under investigation include: Placebo (DRUG), Armodafinil (DRUG).
Who is sponsoring clinical trial NCT01305408?
This trial is sponsored by Cephalon, which has 64 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01305408's enrollment target sits among peer trials
399 962nd of 2000 higher than 1,038 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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