Study of Icariin for Bipolar Disorder and Co-Occurring Substance Use Disorders
Completed · Phase 3
Conditions studied: Bipolar Disorder, Substance Use Disorder
In brief
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.
Key facts
- Study ID
- NCT01979133
- Run by
- University of Texas Southwestern Medical Center
- People needed
- 10
- Starts
- 2013-10-01
- Expected to finish
- 2015-06-01
- Last updated by the study team
- 2017-04-19
Who can join
Age: 18 and older, up to 70. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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
Where it is running
- The University of Texas Southwestern Medical Center — Dallas, Texas, United States
Full record on ClinicalTrials.gov
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