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A Study to Assess the Safety, Tolerability and Efficacy of RG2417 in Bipolar I Depression - NCT00812058-37212(Clinical Trial 261459)



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City:  Nashville
State:  
TN
Zip Code: 37212
Conditions: Bipolar I Depression
Purpose: 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.
Study summary:
Criteria: Inclusion Criteria: - 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 Criteria: - 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
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Data Source: ClinicalTrials.gov
Date Processed: October 7, 2010
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