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

NCT01979133 | Completed Phase 3 Results

• 1 other identifier: 082013-042
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Bipolar Disorder; Substance Use Disorder

Outcome Measures

Primary Outcomes (7)

• Change in Hamilton Rating Scale of Depression (HAMD) From Baseline to Week 8 (Exit)

  HAMD is an observer-rated measure of depressive symptomatology: 1. 17 questions (answers for individual questions range between 0-3 and 0-4). Total score range: 0-52. No subscales for this measure. 2. 0 - no depression; 52 - very severe depression (lower score corresponds to a better outcome). 3. Total score is obtained by summing questions 1-17.

  Baseline vs. Week 8 (Exit)

• Change in Hamilton Rating Scale of Anxiety From Baseline to Week 8 (Exit)

  HAMA is a 14-item observer rated measure of anxiety symptomatology: 1. 14 items in a scale, no subscales. Individual items are score 0 (no anxiety) to 4 (very severe anxiety). 2. Total scores range from 0-56. 3. Total scores represent more severe anxiety. Lower scores represent a better outcome.

  Baseline vs. Week 8 (Exit)

• Change in Quick Inventory of Depressive Symptomatology (QIDS) Score From Baseline to Week 8

  The QIDS is a 16-item self-report measure of depressive symptomatology: 1. 16 items rated on a scale from 0-3. No subscales for this instrument. 2. Total score range is 0-27, where higher score represents higher levels of depression. Lower scores associated with better outcomes. 3. Total score is obtained using the following formula: highest score on items 1-4 + item 5 + highest score on items 6-9 + item 10+item 11+item12+item13+item14+highest score on items 15-16

  Baseline vs. Week 8 (Exit)

• Change in Number of Standard Drinks of Alcohol Per Week Baseline vs. Week 8 (Exit)

  1. Participants are asked to identify the number of alcoholic drinks they consumed on each day within the last 7 days from the day of visit (not including the day of visit). Participants are asked to provide alcohol name and the amount of alcohol they consumed. These values are then converted to standard drinks using a standard drinks calculator. 2. The minimum number of drinks per week is 0. There is no maximum number of drinks per week, as the maximum number is unique to each participant. 3. The general convention for standard drinks used in this study is as follows (oz per one standard drink): * beer: 12 fl oz (5% ABV) * wine: 5 fl oz (10-12% ABV or 18-20% ABV for fortified wine) * hard liquor: 1.5 fl oz (40% ABV)

  Baseline vs. Week 8 (Exit)

• Change in Number of Heavy Drinking Days From Baseline to Week 8 (Exit)

  1. Heavy drinking day is defined as 5 standard drinks per day for men, and 4 standard drinks per day for women. 2. Minimum score is 0 (no drinks); maximum score is unique to each individual participant. Lower score represents a better outcome. 3. Average number of heavy drinking days per week is calculated by asking participants to identify the number of drinks they had on each day during the past 7 days (not including the day of visit). 4. See outcome measure description for "standard drinks per week" for standard drinks convention.

  Baseline vs. Week 8 (Exit)

• Change in Days of Alcohol Use From Baseline to Week 8 (Exit)

  1. Total score range is 0-7 (no days of alcohol use - 7 days of alcohol use). The lower score represents better outcome. 2. Participants are asked to identify days on which they used alcohol in the past week (not including the day of visit).

  Baseline vs. Week 8 (Exit)

• Change in Young Mania Rating Scale (YMRS) From Baseline to Week 8 (Exit)

  The YMRS is an 11-item observer-rated measure of mania symptomatology: 1. 7 individual items are scored between 0-4. 2. 4 individual items are scored between 0-8. 3. Total score range is 0-60, with no subscales. Higher score is indicative of more manic symptoms. Lower score represents better outcomes. 4. Total score is obtained by adding items on the scale together.

  Baseline vs. Week 8 (Exit)

Study Arms (1)

icariin

EXPERIMENTAL

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.

Drug: Icariin

Interventions

Icariin DRUG

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.

Also known as: Epimedium, Horny Goat Weed, Yin Yang Huo

icariin

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Sponsors & Collaborators

• University of Texas Southwestern Medical Center: lead

Study Sites (1)

The University of Texas Southwestern Medical Center

Dallas, Texas, 75390-8849, United States

Location

MeSH Terms

Conditions

Bipolar Disorder; Substance-Related Disorders

Interventions

icariin

Condition Hierarchy (Ancestors)

Bipolar and Related Disorders; Mood Disorders; Mental Disorders; Chemically-Induced Disorders

Results Point of Contact

• Title: E. Sherwood Brown, MD, PhD
• Organization: University of Texas Southwestern Medical Center

sherwood.brown@utsouthwestern.edu

2146466948

Study Officials

• Edson S Brown, M.D., Ph.D.

  University of Texas Southwestern Medical Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: E. Sherwood Brown, M.D., Ph.D., Professor

Study Record Dates

• First Submitted: October 25, 2013
• First Posted: November 8, 2013
• Study Start: October 1, 2013
• Primary Completion: June 1, 2015
• Study Completion: June 1, 2015
• Last Updated: April 19, 2017
• Results First Posted: April 19, 2017

Record last verified: 2017-03

Locations

US (1)