drugset / Trial / NCT01979133

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

NCT01979133 ↗

Phase 3 Completed 10 enrolled University of Texas Southwestern Medical Center
NaSingle-groupOpen-labelTreatment

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.

Timeline

Start
2013-10
Primary completion
2015-06
Completion
2015-06

Outcome

Mixed primary results

registry MEAN Baseline: 17.5 (Standard Deviation 5.2) HAMD scale units NCT01979133 ↗

registry MEAN Week 8: 9 (Standard Deviation 7.4) HAMD scale units NCT01979133 ↗

registry 2. 0 - no depression; 52 - very severe depression (lower score corresponds to a better outcome). NCT01979133 ↗

registry analysis (superiority or other test); Baseline vs Week 8; p = .012; Wilcoxon (Mann-Whitney) NCT01979133 ↗

registry MEAN Baseline: 4.1 (Standard Deviation 2.4) Days Per Week NCT01979133 ↗

registry MEAN Week 8: 3.3 (Standard Deviation 1.0) Days Per Week NCT01979133 ↗

registry analysis (superiority or other test); Baseline vs Week 8; p = .231; Wilcoxon (Mann-Whitney) NCT01979133 ↗

Drugs

EvaluationDrugModalityDoseRoute
Subject Icariin Traditional medicine (herbal / TCM) 100 mg —
Subject Icariin Traditional medicine (herbal / TCM) 200 mg —
Subject Icariin Traditional medicine (herbal / TCM) 300 mg —