A Study to Assess the Safety, Tolerability and Efficacy of RG2417 in Bipolar I Depression
- Registration Number
- NCT00812058
- Lead Sponsor
- Repligen Corporation
- Brief Summary
The purpose of this study is to test a new drug, RG2417, to see how the drug affects symptoms of bipolar I depression and to make sure it is safe in humans.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 180
- Bipolar I Disorder, most recent episode depressed
- History of 2 or more manic or mixed episodes, at least one of which required pharmacologic treatment for manic symptoms
- Current manic, hypomanic or mixed episode
- Rapid cycling bipolar disorder (4 or more mood episodes in the last year)
- Dementia or any other Axis I diagnosis (besides bipolar I) that requires treatment
- Alcohol or drug dependence within 6 months; alcohol or drug abuse within 3 months
- Positive urine drug test for amphetamines, cocaine metabolites, opiates and/or phencyclidine(PCP)
- Axis II diagnosis likely to interfere with study compliance
- Serious suicidal or homicidal risk
- Sensitivity to any of the drug ingredients, including lactose
- Women who are pregnant, breast feeding or refuse to use adequate birth control
- Current seizure disorder
- Current episode of depression is longer than 1 year
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Placebo Placebo Oral placebo taken twice daily for 8 weeks RG2417 RG2417 Oral RG2417 taken twice daily for 8 weeks
- Primary Outcome Measures
Name Time Method MADRS Score Baseline and weekly for 8 weeks
- Secondary Outcome Measures
Name Time Method Safety Findings (includes AE frequency, YMRS Score and CSSR-S Score) Baseline, 8 weeks of study drug dosing and one follow up visit at 4 weeks CGI-BP-S Baseline and weekly for 8 weeks
Trial Locations
- Locations (36)
Duke University Medical Center
🇺🇸Durham, North Carolina, United States
University of Cincinnati
🇺🇸Cincinnati, Ohio, United States
Western Psychiatric Institute Clinic
🇺🇸Pittsburg, Pennsylvania, United States
Vanderbilt University School of Medicine
🇺🇸Nashville, Tennessee, United States
University of Texas, Houston Medical Center
🇺🇸Houston, Texas, United States
University of Utah
🇺🇸Salt Lake City, Utah, United States
Birmingham Psychiatry Pharmaceutical Studies, Inc.
🇺🇸Birmingham, Alabama, United States
Carman Research
🇺🇸Smyrna, Georgia, United States
Valle Vista Health System
🇺🇸Greenwood, Indiana, United States
K&S Professional Research Services
🇺🇸Little Rock, Arkansas, United States
Atlanta Center for Medical Research
🇺🇸Atlanta, Georgia, United States
Massachusetts General Hospital
🇺🇸Boston, Massachusetts, United States
Cleveland Clinic
🇺🇸Cleveland, Ohio, United States
Oregon Center for Clinical Investigations, Inc.
🇺🇸Portland, Oregon, United States
Louisiana State University Health Sciences Center
🇺🇸Shreveport, Louisiana, United States
Behavioral Clinical Research
🇺🇸North Miami, Florida, United States
Affiliated Research Institute
🇺🇸San Diego, California, United States
Johns Hopkins School of Medicine
🇺🇸Baltimore, Maryland, United States
Midwest Clinical Research Center
🇺🇸Dayton, Ohio, United States
Behavioral Medical Research of States Island
🇺🇸Staten Island, New York, United States
IPS Research Company
🇺🇸Oklahoma City, Oklahoma, United States
CNS Healthcare
🇺🇸Memphis, Tennessee, United States
Lincoln Research
🇺🇸Lincoln, Rhode Island, United States
FutureSearch Trials of Dallas
🇺🇸Dallas, Texas, United States
Northwest Clinical Research Center
🇺🇸Bellevue, Washington, United States
University of Texas Health Science Center at San Antonio
🇺🇸San Antonio, Texas, United States
University of Virginia
🇺🇸Charlottesville, Virginia, United States
Richard H. Weisler, MD, PA and Associates
🇺🇸Raleigh, North Carolina, United States
Yale University
🇺🇸New Haven, Connecticut, United States
Clinical Neuroscience Solution, Inc.
🇺🇸Orlando, Florida, United States
Unvieristy of North Carolina - Chapel Hill
🇺🇸Chapel Hill, North Carolina, United States
FutureSearch Trials of Austin
🇺🇸Austin, Texas, United States
University of South Florida College of Medicine
🇺🇸Tampa, Florida, United States
Mayo Clinic Department of Pscyhiatry & Psychology
🇺🇸Rochester, Minnesota, United States
Ralph H. Johnson VA Medical Center
🇺🇸Charleston, South Carolina, United States
Dean Foundation
🇺🇸Middleton, Wisconsin, United States