Study to Evaluate the Efficacy and Safety of Armodafinil Treatment (150 mg/Day) as Adjunctive Therapy in Adults With Major Depression Associated With Bipolar I Disorder
Public ClinicalTrials.gov record NCT01305408. 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.
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Official title
A Double-Blind, Placebo-Controlled, Parallel-Group, Fixed-Dosage Study to Evaluate the Efficacy and Safety of Armodafinil Treatment (150 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
- NCT01305408
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 399 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 2011 (Type not available)
- Primary completion
- Jul 2013 (Actual)
- Completion
- Jul 2013 (Actual)
- Last update posted
- May 26, 2016
2011 – 2013
United States locations
- U.S. sites
- 28
- U.S. states
- 15
- U.S. cities
- 24
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Teva Investigational Site 225 | Birmingham | Alabama | — | — |
| Teva Investigational Site 295 | Sherman Oaks | California | — | — |
| Teva Investigational Site 122 | Temecula | California | — | — |
| Teva Investigational Site 606 | Jacksonville Beach | Florida | — | — |
| Teva Investigational Site 127 | Lauderhill | Florida | — | — |
| Teva Investigational Site 608 | Tampa | Florida | — | — |
| Teva Investigational Site 116 | Atlanta | Georgia | — | — |
| Teva Investigational Site 205 | Atlanta | Georgia | — | — |
| Teva Investigational Site 195 | Park Ridge | Illinois | — | — |
| Teva Investigational Site 611 | Indianapolis | Indiana | — | — |
| Teva Investigational Site 600 | Lafayette | Indiana | — | — |
| Teva Investigational Site 603 | Watertown | Massachusetts | — | — |
| Teva Investigational Site 207 | Brooklyn | New York | — | — |
| Teva Investigational Site 202 | New York | New York | — | — |
| Teva Investigational Site 110 | Staten Island | New York | — | — |
| Teva Investigational Site 411 | Staten Island | New York | — | — |
| Teva Investigational Site 614 | Wilmington | North Carolina | — | — |
| Teva Investigational Site 610 | Cincinnati | Ohio | — | — |
| Teva Investigational Site 615 | Toledo | Ohio | — | — |
| Teva Investigational Site 401 | Oklahoma City | Oklahoma | — | — |
| Teva Investigational Site 609 | Oklahoma City | Oklahoma | — | — |
| Teva Investigational Site 616 | Oklahoma City | Oklahoma | — | — |
| Teva Investigational Site 406 | Allentown | Pennsylvania | — | — |
| Teva Investigational Site 403 | DeSoto | Texas | — | — |
| Teva Investigational Site 612 | Friendswood | Texas | — | — |
| Teva Investigational Site 408 | Salt Lake City | Utah | — | — |
| Teva Investigational Site 613 | Kirkland | Washington | — | — |
| Teva Investigational Site 605 | Spokane | Washington | — | — |
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 102 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT01305408, 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 May 26, 2016 · Synced Nov 4, 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 NCT01305408 live on ClinicalTrials.gov.