Extension Study of the Safety and Efficacy of Armodafinil Treatment as Adjunctive Therapy in Adults With Major Depression Associated With Bipolar I Disorder
Public ClinicalTrials.gov record NCT01121536. 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 6-Month, Open-Label, Flexible-Dosage (150 to 200 mg/Day) Extension Study of the Safety and Efficacy of Armodafinil Treatment 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 this study is to evaluate the safety and tolerability of long term (6 months) armodafinil treatment as adjunctive therapy to mood-stabilizing medications in adults with bipolar I disorder.
Study identification
- NCT ID
- NCT01121536
- Recruitment status
- Terminated
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 867 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
- Apr 29, 2010
- Primary completion
- Oct 30, 2013
- Completion
- Oct 30, 2013
- Last update posted
- Sep 20, 2018
2010 – 2013
United States locations
- U.S. sites
- 66
- U.S. states
- 22
- U.S. cities
- 53
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Teva Investigational Site 113 | Birmingham | Alabama | 35216 | — |
| Teva Investigational Site 225 | Birmingham | Alabama | 35226 | — |
| Teva Investigational Site 229 | Anaheim | California | 92804 | — |
| Teva Investigational Site 217 | Cerritos | California | 90703 | — |
| Teva Investigational Site 223 | Cerritos | California | 90703 | — |
| Teva Investigational Site 115 | Garden Grove | California | 92845 | — |
| Teva Investigational Site 121 | Imperial | California | 92251 | — |
| Teva Investigational Site 303 | Oceanside | California | 92056 | — |
| Teva Investigational Site 400 | Oceanside | California | 92056 | — |
| Teva Investigational Site 200 | Pico Rivera | California | 90660 | — |
| Teva Investigational Site 128 | San Diego | California | 92123 | — |
| Teva Investigational Site 201 | San Diego | California | 92126 | — |
| Teva Investigational Site 192 | Santa Ana | California | 92705 | — |
| Teva Investigational Site 292 | Santa Ana | California | 92705 | — |
| Teva Investigational Site 295 | Sherman Oaks | California | 91403 | — |
| Teva Investigational Site 122 | Temecula | California | 92591 | — |
| Teva Investigational Site 131 | Gainesville | Florida | 32607 | — |
| Teva Investigational Site 132 | Jacksonville | Florida | 32256 | — |
| Teva Investigational Site 606 | Jacksonville Beach | Florida | 32250 | — |
| Teva Investigational Site 127 | Lauderhill | Florida | 33319 | — |
| Teva Investigational Site 119 | North Miami | Florida | 33161 | — |
| Teva Investigational Site 118 | Tampa | Florida | 33613 | — |
| Teva Investigational Site 608 | Tampa | Florida | 33613 | — |
| Teva Investigational Site 205 | Atlanta | Georgia | 30308 | — |
| Teva Investigational Site 116 | Atlanta | Georgia | 30328 | — |
| Teva Investigational Site 204 | Smyrna | Georgia | 30080 | — |
| Teva Investigational Site 107 | Naperville | Illinois | 60563 | — |
| Teva Investigational Site 301 | Naperville | Illinois | 60563 | — |
| Teva Investigational Site 219 | Oakbrook Terrace | Illinois | 60181 | — |
| Teva Investigational Site 195 | Park Ridge | Illinois | 60068 | — |
| Teva Investigational Site 600 | Lafayette | Indiana | 47905 | — |
| Teva Investigational Site 300 | Pikesville | Maryland | 21208 | — |
| Teva Investigational Site 603 | Watertown | Massachusetts | 02472 | — |
| Teva Investigational Site 290 | Flowood | Mississippi | 39232 | — |
| Teva Investigational Site 133 | St Louis | Missouri | 63139 | — |
| Teva Investigational Site 103 | Mount Laurel | New Jersey | 08054 | — |
| Teva Investigational Site 212 | Mount Laurel | New Jersey | 08054 | — |
| Teva Investigational Site 193 | Albuquerque | New Mexico | 87109 | — |
| Teva Investigational Site 207 | Brooklyn | New York | 11201 | — |
| Teva Investigational Site 104 | Brooklyn | New York | 11235 | — |
| Teva Investigational Site 202 | New York | New York | 10023 | — |
| Teva Investigational Site 129 | Rochester | New York | 14618 | — |
| Teva Investigational Site 411 | Staten Island | New York | 10305 | — |
| Teva Investigational Site 110 | Staten Island | New York | 10312 | — |
| Teva Investigational Site 105 | Raleigh | North Carolina | 27609 | — |
| Teva Investigational Site 190 | Beachwood | Ohio | 44125 | — |
| Teva Investigational Site 213 | Canton | Ohio | 44718 | — |
| Teva Investigational Site 610 | Cincinnati | Ohio | 45267 | — |
| Teva Investigational Site 102 | Dayton | Ohio | 45408 | — |
| Teva Investigational Site 401 | Oklahoma City | Oklahoma | 73103 | — |
| Teva Investigational Site 609 | Oklahoma City | Oklahoma | 73112 | — |
| Teva Investigational Site 616 | Oklahoma City | Oklahoma | 73112 | — |
| Teva Investigational Site 406 | Allentown | Pennsylvania | 18104 | — |
| Teva Investigational Site 117 | Media | Pennsylvania | 19063 | — |
| Teva Investigational Site 106 | Memphis | Tennessee | 38119 | — |
| Teva Investigational Site 111 | Austin | Texas | 78756 | — |
| Teva Investigational Site 403 | DeSoto | Texas | 75115 | — |
| Teva Investigational Site 612 | Friendswood | Texas | 77546 | — |
| Teva Investigational Site 228 | Houston | Texas | 77090 | — |
| Teva Investigational Site 224 | Irving | Texas | 75062 | — |
| Teva Investigational Site 409 | Orem | Utah | 84058 | — |
| Teva Investigational Site 408 | Salt Lake City | Utah | 84107 | — |
| Teva Investigational Site 404 | Richmond | Virginia | 23230 | — |
| Teva Investigational Site 100 | Bellevue | Washington | 98007 | — |
| Teva Investigational Site 613 | Kirkland | Washington | 98033 | — |
| Teva Investigational Site 605 | Spokane | Washington | 99204 | — |
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 92 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT01121536, 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 Sep 20, 2018 · Synced Sep 1, 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 protocol, eligibility criteria, and contact information for NCT01121536 live on ClinicalTrials.gov.