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 NCT01072630. 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
- NCT01072630
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 492 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
- Mar 2010 (Type not available)
- Primary completion
- Nov 2012 (Actual)
- Completion
- Nov 2012 (Actual)
- Last update posted
- Apr 27, 2016
2010 – 2012
United States locations
- U.S. sites
- 46
- U.S. states
- 20
- U.S. cities
- 44
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Birmingham Psychiatry Pharmaceutical Studies, Inc | Birmingham | Alabama | — | — |
| South Coast Medical Associates/SC Clinical Trials, Inc. | Anaheim | California | — | — |
| Comprehensive NeuroScience | Cerritos | California | — | — |
| Sun Valley Behavioral Medical | Imperial | California | — | — |
| North County Clinical Research | Oceanside | California | — | — |
| CNRI Los Angeles LLC | Pico Rivera | California | — | — |
| CNRI-San Diego LLC | San Diego | California | — | — |
| Clinical Innovations Inc. | Santa Ana | California | — | — |
| Schuster Medical Research Institute | Sherman Oaks | California | — | — |
| Stanford University Medical Center | Stanford | California | — | — |
| Viking Clinical Research Center | Temecula | California | — | — |
| Comprehensive NeuroScience | Washington D.C. | District of Columbia | — | — |
| Scientific Clinical Research, Inc. | Aventura | Florida | — | — |
| Florida Clinical Research Center | Bradenton | Florida | — | — |
| Clinical Neuroscience Solutions Inc | Jacksonville | Florida | — | — |
| Fidelity Clinical Research | Lauderhill | Florida | — | — |
| Compass Research, LLC | Orlando | Florida | — | — |
| Stedman Clinical Trials, LLC | Tampa | Florida | — | — |
| Atlanta Center for Medical Research | Atlanta | Georgia | — | — |
| Carman Research | Smyrna | Georgia | — | — |
| Hawaii Clinical Research Center | Honolulu | Hawaii | — | — |
| Midwest Center for Neurobehavioral Medicine | Oakbrook Terrace | Illinois | — | — |
| CNS - Comprehensive Neuro Science | Park Ridge | Illinois | — | — |
| Community Research | Crestview Hills | Kentucky | — | — |
| AccelRx Research | Fall River | Massachusetts | — | — |
| Mayo College of Medicine | Rochester | Minnesota | — | — |
| Precise Research Centers | Flowood | Mississippi | — | — |
| CRI Worldwide, LLC | Mount Laurel | New Jersey | — | — |
| Behavioral Medical Research of Brooklyn | Brooklyn | New York | — | — |
| Fieve Clinical Services, Inc. | New York | New York | — | — |
| Medical and Behavioral Health Research | New York | New York | — | — |
| Behavioral Medical Research of Staten Island | Staten Island | New York | — | — |
| Richmond Behavioral Associates | Staten Island | New York | — | — |
| North Coast Clinical Trials, Inc. | Beachwood | Ohio | — | — |
| Neuro-Behavioral Clinical Research, Inc | Canton | Ohio | — | — |
| IPS Research Company | Oklahoma City | Oklahoma | — | — |
| Oregon Center for Clinical Investigators, Inc. (OCCI, Inc.) | Portland | Oregon | — | — |
| Lehigh Center for Clinical Research | Allentown | Pennsylvania | — | — |
| Belmont Center for Comprehensive Treatment | Philadelphia | Pennsylvania | — | — |
| FutureSearch Trials of Neurology | Austin | Texas | — | — |
| Insite Clinical Research | DeSoto | Texas | — | — |
| Red Oak Psychiatry Associates, P.A. | Houston | Texas | — | — |
| University Hills Clinical Research | Irving | Texas | — | — |
| Aspen Clinical Research, LLC | Orem | Utah | — | — |
| Clinical Methods | Salt Lake City | Utah | — | — |
| Alliance Research Group | Richmond | Virginia | — | — |
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 46 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT01072630, 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 18, 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 NCT01072630 live on ClinicalTrials.gov.