A Study to Assess the Safety, Tolerability and Efficacy of RG2417 in Bipolar I Depression

• Status: Completed
• Trial end date: 2010-12-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Repligen Corporation

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