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

Repligen

Status and phase: Completed; Phase 2

Conditions: Bipolar I Depression

Treatments: Drug: RG2417; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT00812058

RG2417-03

Details and patient eligibility

About

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.

Enrollment: 180 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

---

180 participants in 2 patient groups, including a placebo group

RG2417

Experimental group

Description:

Oral RG2417 taken twice daily for 8 weeks

Treatment:

Drug: RG2417

Placebo

Placebo Comparator group

Description:

Oral placebo taken twice daily for 8 weeks

Treatment:

Drug: Placebo