Study of Icariin for Bipolar Disorder and Co-Occurring Substance Use Disorders

• Status: Completed
• Trial end date: 2015-06-01
• Target enrollment: 0
• Participant gender: All

Summary

This study is being done to see if icariin will help with depression in patients with bipolar disorder and alcohol or cocaine use disorders. The pills used in this study contain 20% icariin.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Texas Southwestern Medical Center
• Treatments: Cocaine

Criteria

Inclusion Criteria:

• Current BPD I, II or NOS and cocaine or alcohol use disorder with HAMD score of ≥ 15

• Cocaine or alcohol use with 5 days of initiating study drug

• Men and women

• Age 18-70 years

Exclusion Criteria:

• Psychotic features

• Non-English speakers

• Treatment resistant depression defined as failure of a trial of antidepressants (≥ 4 weeks at a therapeutic dose) in current episode

• Major medical condition including heart, lung, liver or renal disease, cancer, neurological or immunological conditions

• Vulnerable populations including prisoners, cognitively impaired individuals, and pregnant or nursing women

• Prior side effects or allergic reactions to icariin-containing preparations

• Change in psychotropic medications within 14 days of study entry

• Current suicidal ideation (plan and intent), a suicide attempt within the past 12 months or history of > 1 lifetime suicide attempt