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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 is a Phase 2 study of Bipolar I Depression that has completed, run by Cephalon. The registered enrollment target is 257 participants. The trial reports 20 study locations across 7 states.
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.
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 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00481195
The ClinicalTrials.gov registry entry for NCT00481195 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 257 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 1 condition, with Bipolar I Depression appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.
NCT00481195 reports 20 study locations spanning 7 distinct geographic areas - top geographies include 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.
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