Extension Study of the Safety and Efficacy of Armodafinil Treatment as Adjunctive Therapy in Adults With Major Depression Associated With Bipolar I Disorder

Stopped early · Phase 3

Conditions studied: Depression

In brief

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.

Key facts

Study ID

NCT01121536

Run by

Cephalon

People needed

867

Starts

2010-04-30

Expected to finish

2013-10-31

Last updated by the study team

2018-09-21

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

Where it is running

• Teva Investigational Site 225 — Birmingham, Alabama, United States
• Teva Investigational Site 229 — Anaheim, California, United States
• Teva Investigational Site 217 — Cerritos, California, United States
• Teva Investigational Site 223 — Cerritos, California, United States
• Teva Investigational Site 115 — Garden Grove, California, United States
• Teva Investigational Site 121 — Imperial, California, United States
• Teva Investigational Site 303 — Oceanside, California, United States
• Teva Investigational Site 400 — Oceanside, California, United States
• Teva Investigational Site 200 — Pico Rivera, California, United States
• Teva Investigational Site 128 — San Diego, California, United States
• Teva Investigational Site 201 — San Diego, California, United States
• Teva Investigational Site 192 — Santa Ana, California, United States
• Teva Investigational Site 292 — Santa Ana, California, United States
• Teva Investigational Site 295 — Sherman Oaks, California, United States
• Teva Investigational Site 122 — Temecula, California, United States
• Teva Investigational Site 131 — Gainesville, Florida, United States
• Teva Investigational Site 132 — Jacksonville, Florida, United States
• Teva Investigational Site 606 — Jacksonville Beach, Florida, United States
• Teva Investigational Site 127 — Lauderhill, Florida, United States
• Teva Investigational Site 119 — North Miami, Florida, United States
• Teva Investigational Site 118 — Tampa, Florida, United States
• Teva Investigational Site 608 — Tampa, Florida, United States
• Teva Investigational Site 205 — Atlanta, Georgia, United States
• Teva Investigational Site 116 — Atlanta, Georgia, United States
• Teva Investigational Site 113 — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

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