CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 10 enrolled
Drug / intervention
Icariindrug
Likely dose
Icariin 100 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01979133
NCT01979133Phase 3Completed
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A Proof of Concept Study of Icariin for Bipolar Disorder and Co-Occurring Substance Use Disorders

University of Texas Southwestern Medical Center·interventional·Posted Nov 8, 2013·Updated Apr 19, 2017

In Brief

A Phase 3 clinical trial evaluating Icariin for Bipolar Disorder and Substance Use Disorder. Completed, enrolled 10 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsBipolar Disorder, Substance Use Disorder
CountriesUnited States
Collaborators--

Timeline

Phase 3CompletedFinished
2014201520162017201820192020202120222023202420252026
First PostedNov 8, 2013
Enrollment StartOct 1, 2013
Primary CompletionJun 1, 2015
TodayJul 2, 2026
Enrollment to primary: 1.7 yearsPosted 12.7 years ago

Interventions

Icariindrug

Participants will receive 20% icariin (100 mg/day) in a commercially available over-the-counter Horny Goat Weed supplement. A dose titration from 100 mg/day to 200 mg/day will be allowed at week 3 participants with less than a 30% reduction in HAMD and/or still using cocaine or alcohol or have a positive urine drug screen. An additional dose titration to 300 mg/day will be allowed at week 6 for participants with less than a 50% reduction in HAMD scores and/or still using cocaine or alcohol or have a positive urine drug screen.