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

492

Participants

Timeline

Start Date

March 31, 2010

Primary Completion Date

November 30, 2012

Study Completion Date

November 30, 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 (92)

Unknown

Birmingham Psychiatry Pharmaceutical Studies, Inc, Birmingham

South Coast Medical Associates/SC Clinical Trials, Inc., Anaheim

Comprehensive NeuroScience, Cerritos

Sun Valley Behavioral Medical, Imperial

North County Clinical Research, Oceanside

CNRI Los Angeles LLC, Pico Rivera

CNRI-San Diego LLC, San Diego

Clinical Innovations Inc., Santa Ana

Schuster Medical Research Institute, Sherman Oaks

Stanford University Medical Center, Stanford

Viking Clinical Research Center, Temecula

Comprehensive NeuroScience, Washington D.C.

Scientific Clinical Research, Inc., Aventura

Florida Clinical Research Center, Bradenton

Clinical Neuroscience Solutions Inc, Jacksonville

Fidelity Clinical Research, Lauderhill

Compass Research, LLC, Orlando

Stedman Clinical Trials, LLC, Tampa

Atlanta Center for Medical Research, Atlanta

Carman Research, Smyrna

Hawaii Clinical Research Center, Honolulu

Midwest Center for Neurobehavioral Medicine, Oakbrook Terrace

CNS - Comprehensive Neuro Science, Park Ridge

Community Research, Crestview Hills

AccelRx Research, Fall River

Mayo College of Medicine, Rochester

Precise Research Centers, Flowood

CRI Worldwide, LLC, Mount Laurel

Behavioral Medical Research of Brooklyn, Brooklyn

Fieve Clinical Services, Inc., New York

Medical and Behavioral Health Research, New York

Behavioral Medical Research of Staten Island, Staten Island

Richmond Behavioral Associates, Staten Island

North Coast Clinical Trials, Inc., Beachwood

Neuro-Behavioral Clinical Research, Inc, Canton

IPS Research Company, Oklahoma City

Oregon Center for Clinical Investigators, Inc. (OCCI, Inc.), Portland

Lehigh Center for Clinical Research, Allentown

Belmont Center for Comprehensive Treatment, Philadelphia

FutureSearch Trials of Neurology, Austin

Insite Clinical Research, DeSoto

Red Oak Psychiatry Associates, P.A., Houston

University Hills Clinical Research, Irving

Aspen Clinical Research, LLC, Orem

Clinical Methods, Salt Lake City

Alliance Research Group, Richmond

Dr. Gregorio Hugo Sorin, Buenos Aires

INECO, Buenos Aires

Instituto FLENI, Buenos Aires

Sanatorio Prof. León S. Morra SA, Córdoba

Centro de Investigación y asistencia en Psiquiatria (CIAP), Rosario

B.A. Psychiatric Research Cent, Buenos Aires

Neurotherapy Victoria Clinical Trials, Malvern

Northern Area Mental Health Services Northern Psychiatric R, Melbourne

MHAT Doverie, Sofia

"Psychiatric clinic, University Hospital Alexandrovska", Sofia

MHAT - Sveta Marina, Varna

District Department of Psychiatric Disorders With Stationary, Burgas

State Psychiatric Hospital - Pazardjik, Pazardzhik

"Psychiatric clinic for women UMHAT Dr. Georgi Stranski", Pleven

ODPZS- EOOD, Plovdiv, Bulgaria, Plovdiv

"Diagnostic Consultative Center Tchaika", Varna

Grey Nuns Hospital, Edmonton

Dr. Alexander McIntyre, Inc., Penticton

Providence Care Mental Health Services, Kingston

Medical Research Associates, Mississauga

Hôpital Louis Hlafontaine, Montreal

CMP/CHS du Jura, Dole

Centre Hospitalier de Jonzac, Jonzac

Hopital Universitaire Caremeau-Batiment Polyvalent, Service, Nîmes

Szpital Uniwersytecki im.dr.A.Jurasza w Bydgoszczy, Bydgoszcz

Klinika Chorob Psychicznych i Zaburzen Nerwicowych GUM, Gdansk

Wojewodzki Szpital Psychiatryczny im. prof. Tadeusza Bilikie, Gdansk

Malopolskie Centrum Medyczne, Krakow

Cape Trial Centre, Cape Town

Flexivest Fourteen Research Centre, Cape Town

Knighton Surgery, Cape Town

Vista Clinic, Centurion

Dr Magnus & Dr Brink, Johannesburg

Paarl Medical Centre, Paarl

Dey Clinic, Pretoria

Hospital del Henares, Coslada (Madrid)

Clínica Universitaria de Navarra, Pamplona

Hospital Psiquiátrico de Álava, Vitoria-Gasteiz

Hospital Santiago Apostol, Vitoria-Gasteiz

Danylo Galitsky Lviv State Medical University, Lviv

Odessa Regional Mental Hospital #2, S. Oleksandrivka

Vinnytsa National Medical University named by M.I. Pirogov, Vinnitsa

Donetsk National Medical University n.a. M. Horkyy, Donetsk

"Public Institution Institute of Neurology, Psychiatry and N", Kharkiv

Kiev City Psychoneurological Hospital N 1, CNTRP, Kiev

Odessa Regional Psychoneurology Dispensary, Odesa

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Cephalon

INDUSTRY

NCT01072630 - Study to Evaluate the Efficacy and Safety of Armodafinil Treatment as Adjunctive Therapy in Adults With Major Depression Associated With Bipolar I Disorder | Biotech Hunter | Biotech Hunter