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NCT01072630 · ClinicalTrials.gov registry record · Phase 3
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 of Depression, sponsored by Cephalon.
- Completed
- Registry status
- Phase 3
- Development phase
- 492
- Enrollment target
- 20
- Study locations
NCT01072630: Completed Phase 3 study of Depression, sponsored by Cephalon.
NCT01072630 is a Phase 3 study of Depression that has completed, run by Cephalon. The registered enrollment target is 492 participants, below the 786-participant average among 679 other Depression trials with a reported enrollment target (37% lower). The trial reports 20 study locations across 5 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01072630, a Phase 3 study of Depression, has completed, sponsored by Cephalon.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 492 participants
- Enrollment target
- 20
- Study locations
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.
Conditions Studied
Interventions
- DRUG Placebo
- DRUG Armodafinil
Study Locations (20)
California
- South Coast Medical Associates/SC Clinical Trials, Inc. - Anaheim
- Comprehensive NeuroScience - Cerritos
- Sun Valley Behavioral Medical - Imperial
- North County Clinical Research - Oceanside
- CNRI Los Angeles LLC - Pico Rivera
- CNRI-San Diego LLC - San Diego
- Clinical Innovations Inc. - Santa Ana
- Schuster Medical Research Institute - Sherman Oaks
- Stanford University Medical Center - Stanford
- Viking Clinical Research Center - Temecula
Florida
- Scientific Clinical Research, Inc. - Aventura
- Florida Clinical Research Center - Bradenton
- Clinical Neuroscience Solutions Inc - Jacksonville
- Fidelity Clinical Research - Lauderhill
- Compass Research, LLC - Orlando
- Stedman Clinical Trials, LLC - Tampa
Georgia
- Atlanta Center for Medical Research - Atlanta
- Carman Research - Smyrna
Alabama
- Birmingham Psychiatry Pharmaceutical Studies, Inc - Birmingham
District of Columbia
- Comprehensive NeuroScience - Washington D.C.
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 492 participants |
| Start Date | 2010-03 |
| Est. Completion | 2012-11 |
| Phase | Phase 3 |
What the finished NCT01072630 record still lists
NCT01072630 is an interventional study that assigns participants to a tested intervention. The registered 492 participants enrollment target is mid-sized for trials with a published cap, below the 786-participant average among 679 other Depression trials with a reported enrollment target (37% lower).
The record links to 1 condition, with Depression appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.
NCT01072630 names 20 study sites across 5 states, led by California, Florida, Georgia.
Frequently Asked Questions
What is clinical trial NCT01072630 about?
NCT01072630 is a clinical study titled "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 NCT01072630?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 492 participants. The study started on 2010-03. Estimated completion is 2012-11.
What conditions does trial NCT01072630 study?
This clinical trial studies the following conditions: Depression.
What interventions are being tested in trial NCT01072630?
The interventions under investigation include: Placebo (DRUG), Armodafinil (DRUG).
Who is sponsoring clinical trial NCT01072630?
This trial is sponsored by Cephalon, which has 64 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01072630 being conducted?
This trial has 20 study locations across Alabama, California, District of Columbia, Florida, Georgia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Depression
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT01072630's enrollment target sits among peer trials
492 89th of 679 higher than 591 of 679 other Depression trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Depression 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.
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