- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01979133
Study of Icariin for Bipolar Disorder and Co-Occurring Substance Use Disorders
A Proof of Concept Study of Icariin for Bipolar Disorder and Co-Occurring Substance Use Disorders
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Ten adults with current bipolar disorder (BPD) and current cocaine or alcohol use disorders, based on a structured clinical interview (SCID), and a baseline Hamilton Rating Scale for Depression (HAMD) score of ≥ 15, will be recruited through a patient database of a recently completed study of bipolar disorder patients with cocaine dependence. Informed consent will be obtained. The clinician version of the structured Clinical Interview for DSM-IV (SCID) is a brief structured interview for major Axis I disorders in DSM-IV including major depressive disorder, dysthymic disorder, bipolar disorders, psychotic disorders, anxiety disorders, eating disorders, and alcohol and substance abuse/dependence. This will be given at baseline to confirm bipolar disorder diagnosis. Blood draws and a physical examination by a physician will be performed at baseline to general physical health. Participants will return to receive icariin (100 mg/day)once their general health and diagnosis are confirmed.
Participants will be assessed at baseline and weekly with the HAMD and a urine drug screen, for 8 consecutive weeks after initiating intervention (icariin). A dose titration from 100 mg/day to 200 mg/day will be allowed at week 3 for 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.
Pill counts will be conducted, and a list of current medications and doses will be obtained at each visit. Participants will be compensated and receive bus passes at each appointment. Participants will be evaluated by both the research assistant (RA) and principal investigator (PI) at each follow-up appointment.
The HAM-D will be the primary outcome measure. Other cognitive assessments will be performed at these same visits as well.
Study Type
Enrollment (Actual)
Phase
- Phase 3
Contacts and Locations
Study Locations
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Texas
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Dallas, Texas, United States, 75390-8849
- The University of Texas Southwestern Medical Center
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: icariin
Icariin will be given 100 mg/day.
A dose titration from 100 mg/day to 200 mg/day will be allowed at week 3 for 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.
|
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.
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in Hamilton Rating Scale of Depression (HAMD) From Baseline to Week 8 (Exit)
Time Frame: Baseline vs. Week 8 (Exit)
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HAMD is an observer-rated measure of depressive symptomatology:
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Baseline vs. Week 8 (Exit)
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Change in Hamilton Rating Scale of Anxiety From Baseline to Week 8 (Exit)
Time Frame: Baseline vs. Week 8 (Exit)
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HAMA is a 14-item observer rated measure of anxiety symptomatology:
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Baseline vs. Week 8 (Exit)
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Change in Quick Inventory of Depressive Symptomatology (QIDS) Score From Baseline to Week 8
Time Frame: Baseline vs. Week 8 (Exit)
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The QIDS is a 16-item self-report measure of depressive symptomatology:
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Baseline vs. Week 8 (Exit)
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Change in Number of Standard Drinks of Alcohol Per Week Baseline vs. Week 8 (Exit)
Time Frame: Baseline vs. Week 8 (Exit)
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Baseline vs. Week 8 (Exit)
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Change in Number of Heavy Drinking Days From Baseline to Week 8 (Exit)
Time Frame: Baseline vs. Week 8 (Exit)
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Baseline vs. Week 8 (Exit)
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Change in Days of Alcohol Use From Baseline to Week 8 (Exit)
Time Frame: Baseline vs. Week 8 (Exit)
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Baseline vs. Week 8 (Exit)
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Change in Young Mania Rating Scale (YMRS) From Baseline to Week 8 (Exit)
Time Frame: Baseline vs. Week 8 (Exit)
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The YMRS is an 11-item observer-rated measure of mania symptomatology:
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Baseline vs. Week 8 (Exit)
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Collaborators and Investigators
Investigators
- Principal Investigator: Edson S Brown, M.D., Ph.D., UT Southwestern Medical Center
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 082013-042
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