Phase 3
N=10
Study of Icariin for Bipolar Disorder and Co-Occurring Substance Use Disorders
Bipolar Disorder · Substance Use Disorder
Bottom Line
View on ClinicalTrials.gov: NCT01979133 ↗Enrolled (actual)
10
Serious AEs
0.0%
Results posted
Apr 2017
Primary outcome: Primary: Change in Hamilton Rating Scale of Depression (HAMD) From Baseline to Week 8 (Exit) — 17.5; 9 HAMD scale units — p=.012
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Icariin (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- University of Texas Southwestern Medical Center
- Primary completion
- Jun 2015
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Hamilton Rating Scale of Depression (HAMD) From Baseline to Week 8 (Exit) |
17.5; 9 | .012 sig |
| PRIMARY Change in Hamilton Rating Scale of Anxiety From Baseline to Week 8 (Exit) |
15.2; 4.6 | .005 sig |
| PRIMARY Change in Quick Inventory of Depressive Symptomatology (QIDS) Score From Baseline to Week 8 |
11.8; 5.7 | .017 sig |
| PRIMARY Change in Number of Standard Drinks of Alcohol Per Week Baseline vs. Week 8 (Exit) |
38.8; 10.3 | .038 sig |
| PRIMARY Change in Number of Heavy Drinking Days From Baseline to Week 8 (Exit) |
3.2; 1.2 | .034 sig |
| PRIMARY Change in Days of Alcohol Use From Baseline to Week 8 (Exit) |
4.1; 3.3 | .231 |
| PRIMARY Change in Young Mania Rating Scale (YMRS) From Baseline to Week 8 (Exit) |
8.8; 3.3 | .066 |
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.
Eligibility 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
Data sourced from ClinicalTrials.gov (NCT01979133). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.