Armodafinil Treatment as Adjunctive Therapy in Adults With Major Depression Associated With Bipolar I Disorder
Public ClinicalTrials.gov record NCT00481195. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
An 8 Week Double Blind, Placebo-Controlled, Parallel Group, Fixed Dosage Study to Evaluate the Efficacy and Safety of Armodafinil Treatment (150mg/Day) as Adjunctive Therapy in Adults With Major Depression Associated With Bipolar I Disorder
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT00481195
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 2
- Enrollment
- 257 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 18 Years to 65 Years
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Jun 2007 (Type not available)
- Primary completion
- Dec 2008 (Actual)
- Completion
- Dec 2008 (Actual)
- Last update posted
- Jul 19, 2013
2007 – 2008
United States locations
- U.S. sites
- 42
- U.S. states
- 16
- U.S. cities
- 38
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Birmingham Research Group | Birmingham | Alabama | 35216 | — |
| Birmingham Psychiatry Pharmaceutical Studies, Inc | Birmingham | Alabama | 35226 | — |
| Synergy Clinical Research Center | Escondido | California | 92025 | — |
| Bay Area Research Institute | Lafayette | California | 94549 | — |
| Synergy Clinical Research Center | National City | California | 91950 | — |
| Excell Research | Oceanside | California | 92056 | — |
| Pacific Clinical Research Medical Group | Orange | California | 92868 | — |
| CNRI Los Angeles LLC | Pico Rivera | California | 90660 | — |
| Pacific Clinical Research Medical Group | Riverside | California | 92506 | — |
| California Neuropsychopharmacology Clinical Research Inst | San Diego | California | 92126 | — |
| Stanford University | Stanford | California | 94305 | — |
| Clinical Neuroscience Solutions Inc | Jacksonville | Florida | 32216 | — |
| Fidelity Clinical Research | Lauderhill | Florida | 33319 | — |
| Stedman Clinical Trials, LLC | Tampa | Florida | 33613 | — |
| Janus Center for Psychiatric Research | West Palm Beach | Florida | 33407 | — |
| Atlanta Center for Clinical Research | Atlanta | Georgia | 30308 | — |
| Carman Research | Smyrna | Georgia | 30080 | — |
| Psychiatric Medicine Associates | Skokie | Illinois | 60076 | — |
| Capital Clinical Research Associates | Rockville | Maryland | 20852 | — |
| CNS Research Institute | Clementon | New Jersey | 08021 | — |
| Behavioral Medical Research of Brooklyn | Brooklyn | New York | 11201 | — |
| Social Psychiatry Research Institute | Brooklyn | New York | 11235 | — |
| Social Psychiatry Research Institute | New York | New York | 10021 | — |
| Medical & Behavioral Health Research | New York | New York | 10023 | — |
| Behavioral Medical Research of Staten Island | Staten Island | New York | 10305 | — |
| Richard Weisler, MD and Associates | Raleigh | North Carolina | 27609 | — |
| Piedmont Clinical Trials, Inc. | Winston-Salem | North Carolina | 27104 | — |
| Mood Disorders Program | Cleveland | Ohio | 44106 | — |
| Midwest Clinical Research Center | Dayton | Ohio | 45408 | — |
| Sooner Clinical Research | Oklahoma City | Oklahoma | 73112 | — |
| Oregon Center for Clinical Investigations, Inc. | Salem | Oregon | 97301 | — |
| Dubois Regional Medical Center - Behavioral Health Services | DuBois | Pennsylvania | 15801 | — |
| Keystone Clinical Studies LLC | Norristown | Pennsylvania | 19401 | — |
| University of Pennsylvania | Philadelphia | Pennsylvania | 19104 | — |
| CRI Worldwide | Philadelphia | Pennsylvania | 19139 | — |
| Clinical Neuroscience Solutions, Inc. | Memphis | Tennessee | 38119 | — |
| Community Clinical Research | Austin | Texas | 78754 | — |
| Claghorn-Lesem Research Clinic, LTD | Bellaire | Texas | 77401 | — |
| University Hills Clinical Research | Irving | Texas | 75062 | — |
| Grayline Clinical Drug Trials | Wichita Falls | Texas | 76309 | — |
| Northwest Clinical Research Center | Bellevue | Washington | 98004 | — |
| Eastside Therapeutic Resource | Kirkland | Washington | 98033 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 13 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT00481195, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Jul 19, 2013 · Synced Oct 22, 2026
Related: full search, browse by condition, browse by drug or therapy, browse by sponsor, browse by U.S. city.
Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT00481195 live on ClinicalTrials.gov.