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NCT00481195 · ClinicalTrials.gov registry record · Phase 2
Armodafinil Treatment as Adjunctive Therapy in Adults With Major Depression Associated With Bipolar I Disorder
A Phase 2 study of Bipolar I Depression, sponsored by Cephalon.
- Completed
- Registry status
- Phase 2
- Development phase
- 257
- Enrollment target
- 20
- Study locations
NCT00481195: Completed Phase 2 study of Bipolar I Depression, sponsored by Cephalon.
NCT00481195 is a Phase 2 study of Bipolar I Depression that has completed, run by Cephalon. The registered enrollment target is 257 participants, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (93% higher). The trial reports 20 study locations across 7 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00481195, a Phase 2 study of Bipolar I Depression, has completed, sponsored by Cephalon.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 257 participants
- Enrollment target
- 20
- Study locations
Study Summary
The primary objective of the study is to determine if armodafinil treatment, at a dosage of 150 mg/day, is more effective than placebo treatment as adjunctive therapy for adults who are experiencing a major depressive episode associated with Bipolar I Disorder and who are inadequately responsive to their current treatment for a current major depressive episode.
Primary Outcome
The IDS C30 is a standardized 30 item, clinician rated scale to assess the severity of a patient's depressive symptoms. The scale uses the 9 symptom domains of the DSM-IV criteria to measure symptom severity. The scores range from a minimum of 0 to a maximum score of 84. The higher the score the more severe the symptoms of depression. The data presented here summarizes the change from baseline to Endpoint (either week 8 or the last observation after baseline) in the total score of the IDS-C30.
Conditions Studied
Interventions
- DRUG Placebo
- DRUG Armodafinil
Study Locations (20)
California
- Synergy Clinical Research Center - Escondido
- Bay Area Research Institute - Lafayette
- Synergy Clinical Research Center - National City
- Excell Research - Oceanside
- Pacific Clinical Research Medical Group - Orange
- CNRI Los Angeles LLC - Pico Rivera
- Pacific Clinical Research Medical Group - Riverside
- California Neuropsychopharmacology Clinical Research Inst - San Diego
- Stanford University - Stanford
Florida
- Clinical Neuroscience Solutions Inc - Jacksonville
- Fidelity Clinical Research - Lauderhill
- Stedman Clinical Trials, LLC - Tampa
- Janus Center for Psychiatric Research - West Palm Beach
Alabama
- Birmingham Research Group - Birmingham
- Birmingham Psychiatry Pharmaceutical Studies, Inc - Birmingham
Georgia
- Atlanta Center for Clinical Research - Atlanta
- Carman Research - Smyrna
Illinois
- Psychiatric Medicine Associates - Skokie
Maryland
- Capital Clinical Research Associates - Rockville
New Jersey
- CNS Research Institute - Clementon
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 257 participants |
| Start Date | 2007-06 |
| Est. Completion | 2008-12 |
| Phase | Phase 2 |
What the finished NCT00481195 record still lists
NCT00481195 is an interventional study that assigns participants to a tested intervention. The registered 257 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 (93% higher).
The record links to 1 condition, with Bipolar I Depression appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.
NCT00481195 names 20 study sites across 7 states, led by California, Florida, Alabama.
Frequently Asked Questions
What is clinical trial NCT00481195 about?
NCT00481195 is a clinical study titled "Armodafinil Treatment as Adjunctive Therapy in Adults With Major Depression Associated With Bipolar I Disorder". The primary objective of the study is to determine if armodafinil treatment, at a dosage of 150 mg/day, is more effective than placebo treatment as adjunctive therapy for adults who are experiencing a major depressive episode associated with Bipolar I Disorder and who are inadequately responsive to ...
What is the current status of trial NCT00481195?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 257 participants. The study started on 2007-06. Estimated completion is 2008-12.
What conditions does trial NCT00481195 study?
This clinical trial studies the following conditions: Bipolar I Depression.
What interventions are being tested in trial NCT00481195?
The interventions under investigation include: Placebo (DRUG), Armodafinil (DRUG).
Who is sponsoring clinical trial NCT00481195?
This trial is sponsored by Cephalon, which has 64 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00481195 being conducted?
This trial has 20 study locations across Alabama, California, Florida, Georgia, Illinois. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Bipolar I 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 NCT00481195's enrollment target sits among peer trials
257 214th of 2000 higher than 1,786 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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