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)
Birmingham Psychiatry Pharmaceutical Studies, Inc.
🇺🇸Birmingham, Alabama, United States
K&S Professional Research Services
🇺🇸Little Rock, Arkansas, United States
Affiliated Research Institute
🇺🇸San Diego, California, United States
Yale University
🇺🇸New Haven, Connecticut, United States
Behavioral Clinical Research
🇺🇸North Miami, Florida, United States
Clinical Neuroscience Solution, Inc.
🇺🇸Orlando, Florida, United States
University of South Florida College of Medicine
🇺🇸Tampa, Florida, United States
Atlanta Center for Medical Research
🇺🇸Atlanta, Georgia, United States
Carman Research
🇺🇸Smyrna, Georgia, United States
Valle Vista Health System
🇺🇸Greenwood, Indiana, United States
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