Status:
COMPLETED
A Study to Assess the Safety, Tolerability and Efficacy of RG2417 in Bipolar I Depression
Lead Sponsor:
Repligen Corporation
Conditions:
Bipolar I Depression
Eligibility:
All Genders
18-65 years
Phase:
PHASE2
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.
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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
Key Trial Info
Start Date :
November 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2010
Estimated Enrollment :
180 Patients enrolled
Trial Details
Trial ID
NCT00812058
Start Date
November 1 2008
End Date
December 1 2010
Last Update
January 17 2011
Active Locations (36)
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1
Birmingham Psychiatry Pharmaceutical Studies, Inc.
Birmingham, Alabama, United States, 35226
2
K&S Professional Research Services
Little Rock, Arkansas, United States, 72201
3
Affiliated Research Institute
San Diego, California, United States, 92108
4
Yale University
New Haven, Connecticut, United States, 06519