257
Participants
Start Date
June 30, 2007
Primary Completion Date
December 31, 2008
Study Completion Date
December 31, 2008
Armodafinil
Patients were randomly assigned to begin oral treatment with armodafinil, which was titrated to 150 mg/day (3 tablets). Armodafinil was titrated up to the target dosage of 150 mg/day (daily dose was administered each morning). Patients began taking blinded armodafinil at a dose of 50 mg/day (1 tablet) on the day following the baseline visit. Doses were increased by 50 mg/day (1 tablet) to a dose of 100 mg/day on Day 2 and 3, and then again by 50 mg /day on day 4 for a target dose of 150 mg/day. Following titration, patients continued taking 150 mg/day of armodafinil for the duration of the study. If a patient was unable to tolerate (recurrent or persistent adverse events) the study drug, 1 reduction in dosage (ie, minimum dosage 100 mg/day \[2 tablets\]) was allowed. The dosage could not be increased after it was decreased.
Placebo
Patients were randomly assigned to begin oral treatment with placebo, which was titrated to 3 tablets. Placebo tablets matching the 50 mg armodafinil tablet were used in a manner identical to that of the armodafinil tablets. Study drug was titrated up to the target dosage of 3 tablets / day (daily dose was administered each morning). Patients began taking blinded study drug at a dose of 1 tablet daily on the day following the baseline visit. Doses were increased by 1 tablet to a dose of 2 tablets/day on Day 2 and 3, and then again by 1 tablet /day on day 4 for a target dose of 3 tablets/day. Following titration, patients continued taking 3 tablets/day of study drug for the duration of the study. If a patient was unable to tolerate (recurrent or persistent adverse events) the study drug, 1 reduction in dosage (ie, minimum dosage 2 tablets/day) was allowed. The dosage could not be increased after it was decreased.
Call For Information - Center Site #2, Sofia
Call For Information, Sofia
Call For Information - Center Site #2, Plovdiv
Call For Information, Plovdiv
Call For Information, Burgas
Social Psychiatry Research Institute, New York
Medical & Behavioral Health Research, New York
Behavioral Medical Research of Staten Island, Staten Island
Behavioral Medical Research of Brooklyn, Brooklyn
Social Psychiatry Research Institute, Brooklyn
Dubois Regional Medical Center - Behavioral Health Services, DuBois
University of Pennsylvania, Philadelphia
CRI Worldwide, Philadelphia
Keystone Clinical Studies LLC, Norristown
Capital Clinical Research Associates, Rockville
Piedmont Clinical Trials, Inc., Winston-Salem
Richard Weisler, MD and Associates, Raleigh
Carman Research, Smyrna
Atlanta Center for Clinical Research, Atlanta
Clinical Neuroscience Solutions Inc, Jacksonville
Fidelity Clinical Research, Lauderhill
Janus Center for Psychiatric Research, West Palm Beach
Stedman Clinical Trials, LLC, Tampa
Birmingham Research Group, Birmingham
Birmingham Psychiatry Pharmaceutical Studies, Inc, Birmingham
Clinical Neuroscience Solutions, Inc., Memphis
Mood Disorders Program, Cleveland
Midwest Clinical Research Center, Dayton
Psychiatric Medicine Associates, Skokie
Sooner Clinical Research, Oklahoma City
University Hills Clinical Research, Irving
Grayline Clinical Drug Trials, Wichita Falls
Claghorn-Lesem Research Clinic, LTD, Bellaire
Community Clinical Research, Austin
CNRI Los Angeles LLC, Pico Rivera
Synergy Clinical Research Center, National City
Synergy Clinical Research Center, Escondido
Excell Research, Oceanside
California Neuropsychopharmacology Clinical Research Inst, San Diego
Pacific Clinical Research Medical Group, Riverside
Pacific Clinical Research Medical Group, Orange
Stanford University, Stanford
Bay Area Research Institute, Lafayette
Oregon Center for Clinical Investigations, Inc., Salem
Northwest Clinical Research Center, Bellevue
Eastside Therapeutic Resource, Kirkland
Call For Information, Piteşti
Call For Information, Târgovişte
CNS Research Institute, Clementon
Call For Information, Budapest
Call For Information, Nagykálló
Call For Information, Bucharest
Call For Information, Bucharest
Call For Information - Center Site #2, Bucharest
Call For Information, Bucharest
Lead Sponsor
Cephalon
INDUSTRY