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

PHASE3CompletedINTERVENTIONAL
Enrollment

433

Participants

Timeline

Start Date

January 31, 2010

Primary Completion Date

March 31, 2012

Study Completion Date

March 31, 2012

Conditions
Depression
Interventions
DRUG

Armodafinil

Doses of either 150mg/day or 200 mg/day in tablet form taken orally, once daily in the morning.

DRUG

Placebo

Matching Placebo, also in tablet form taken orally, once daily in the morning.

Trial Locations (40)

Unknown

Birmingham Research Group, Birmingham

Southwestern Research, Beverly Hills

Collaborative NeuroScience Network, Garden Grove

Sun Valley Behavioral Medical, Imperial

University of California Irvine, Irvine

Excell Research, Oceanside

Artemis Institute for Clinical Research, San Diego

Clinical Innovations Inc., Santa Ana

Viking Clinical Research Center, Temecula

CNS Clinical Research Group - Florida Clinical Research Cent, Coral Springs

Gulfcoast Clinical Research Center, Fort Myers

Sarkis Clinical Trials, Gainesville

Dr. Vijapura and Assoc., Jacksonville

Fidelity Clinical Research, Lauderhill

Clinical Neuroscience Solutions, Inc., Orlando

University of South Florida, Tampa

Comprehensive Neuroscience, Inc, Atlanta

Northwest Behavioral Research Center, Roswell

AMR Baber Research Inc., Naperville

American Medical Research, Oak Brook

CNS - Comprehensive Neuro Science, Park Ridge

Pharmasite Research, Inc, Baltimore

AccelRx Research, Fall River

Mid-America Clinical Research, LLC, St Louis

CRI Worldwide, LLC, Mount Laurel

Albequerque Neuroscience, Albuquerque

Social Psychiatry Research Institute, Brooklyn

Eastside Comprehensive Medical Center, New York

Finger Lakes Clinical Research, Rochester

Richmond Behavioral Associates, Staten Island

Richard Weisler, MD and Associates, Raleigh

Charak Clinical Research Center, Beachwood

Midwest Clinical Research Center, Dayton

Oregon Center for Clinical Investigations, Inc, Salem

Suburban Research Associates, Media

Scranton Counseling Center, Scranton

Carolina Clinical Trials, Inc., Charleston

Community Clinical Research, Austin

FutureSearch Trials of Neurology, Austin

Northwest Clinical Research Center, Bellevue

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Cephalon

INDUSTRY