A Study to Evaluate the Efficacy and Safety of Armodafinil Treatment as Adjunctive Therapy in Adults With Major Depression Associated With Bipolar I Disorder
Public ClinicalTrials.gov record NCT01072929. 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
A Double-Blind, Placebo-Controlled, Parallel-Group, Fixed-Dosage Study to Evaluate the Efficacy and Safety of Armodafinil Treatment (150 and 200 mg/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 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.
Study identification
- NCT ID
- NCT01072929
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 433 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
- Jan 2010 (Type not available)
- Primary completion
- Mar 2012 (Actual)
- Completion
- Mar 2012 (Actual)
- Last update posted
- Apr 27, 2016
2010 – 2012
United States locations
- U.S. sites
- 40
- U.S. states
- 18
- U.S. cities
- 39
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Birmingham Research Group | Birmingham | Alabama | — | — |
| Southwestern Research | Beverly Hills | California | — | — |
| Collaborative NeuroScience Network | Garden Grove | California | — | — |
| Sun Valley Behavioral Medical | Imperial | California | — | — |
| University of California Irvine | Irvine | California | — | — |
| Excell Research | Oceanside | California | — | — |
| Artemis Institute for Clinical Research | San Diego | California | — | — |
| Clinical Innovations Inc. | Santa Ana | California | — | — |
| Viking Clinical Research Center | Temecula | California | — | — |
| CNS Clinical Research Group - Florida Clinical Research Cent | Coral Springs | Florida | — | — |
| Gulfcoast Clinical Research Center | Fort Myers | Florida | — | — |
| Sarkis Clinical Trials | Gainesville | Florida | — | — |
| Dr. Vijapura and Assoc. | Jacksonville | Florida | — | — |
| Fidelity Clinical Research | Lauderhill | Florida | — | — |
| Clinical Neuroscience Solutions, Inc. | Orlando | Florida | — | — |
| University of South Florida | Tampa | Florida | — | — |
| Comprehensive Neuroscience, Inc | Atlanta | Georgia | — | — |
| Northwest Behavioral Research Center | Roswell | Georgia | — | — |
| AMR Baber Research Inc. | Naperville | Illinois | — | — |
| American Medical Research | Oak Brook | Illinois | — | — |
| CNS - Comprehensive Neuro Science | Park Ridge | Illinois | — | — |
| Pharmasite Research, Inc | Baltimore | Maryland | — | — |
| AccelRx Research | Fall River | Massachusetts | — | — |
| Mid-America Clinical Research, LLC | St Louis | Missouri | — | — |
| CRI Worldwide, LLC | Mount Laurel | New Jersey | — | — |
| Albequerque Neuroscience | Albuquerque | New Mexico | — | — |
| Social Psychiatry Research Institute | Brooklyn | New York | — | — |
| Eastside Comprehensive Medical Center | New York | New York | — | — |
| Finger Lakes Clinical Research | Rochester | New York | — | — |
| Richmond Behavioral Associates | Staten Island | New York | — | — |
| Richard Weisler, MD and Associates | Raleigh | North Carolina | — | — |
| Charak Clinical Research Center | Beachwood | Ohio | — | — |
| Midwest Clinical Research Center | Dayton | Ohio | — | — |
| Oregon Center for Clinical Investigations, Inc | Salem | Oregon | — | — |
| Suburban Research Associates | Media | Pennsylvania | — | — |
| Scranton Counseling Center | Scranton | Pennsylvania | — | — |
| Carolina Clinical Trials, Inc. | Charleston | South Carolina | — | — |
| Community Clinical Research | Austin | Texas | — | — |
| FutureSearch Trials of Neurology | Austin | Texas | — | — |
| Northwest Clinical Research Center | Bellevue | Washington | — | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT01072929, 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 Apr 27, 2016 · Synced Oct 23, 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 NCT01072929 live on ClinicalTrials.gov.