Trial Outcomes & Findings for Study of Icariin for Bipolar Disorder and Co-Occurring Substance Use Disorders (NCT NCT01979133)
NCT ID: NCT01979133
Last Updated: 2017-04-19
Results Overview
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.
COMPLETED
PHASE3
10 participants
Baseline vs. Week 8 (Exit)
2017-04-19
Participant Flow
Participant milestones
| Measure |
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.
Icariin: 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.
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|---|---|
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Overall Study
STARTED
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10
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Overall Study
COMPLETED
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7
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Overall Study
NOT COMPLETED
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3
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Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Study of Icariin for Bipolar Disorder and Co-Occurring Substance Use Disorders
Baseline characteristics by cohort
| Measure |
Icariin
n=10 Participants
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.
Icariin: 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.
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|---|---|
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Age, Continuous
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51.4 years
STANDARD_DEVIATION 7.3 • n=99 Participants
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Sex: Female, Male
Female
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4 Participants
n=99 Participants
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Sex: Female, Male
Male
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6 Participants
n=99 Participants
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Race (NIH/OMB)
American Indian or Alaska Native
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0 Participants
n=99 Participants
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Race (NIH/OMB)
Asian
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1 Participants
n=99 Participants
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Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
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0 Participants
n=99 Participants
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Race (NIH/OMB)
Black or African American
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5 Participants
n=99 Participants
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Race (NIH/OMB)
White
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4 Participants
n=99 Participants
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Race (NIH/OMB)
More than one race
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0 Participants
n=99 Participants
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Race (NIH/OMB)
Unknown or Not Reported
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0 Participants
n=99 Participants
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Region of Enrollment
United States
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10 participants
n=99 Participants
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PRIMARY outcome
Timeframe: Baseline vs. Week 8 (Exit)Population: The total enrollment goal was 10. One participant dropped out during the baseline II visit, thus week 8 score was not obtained for that participant and the change from baseline to week 8 could not be collected. Thus, the analysis includes 9 participants instead of proposed 10.
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.
Outcome measures
| Measure |
Baseline
n=9 Participants
Baseline HAMD Score
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Week 8
n=9 Participants
Week 8 HAMD Score
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|---|---|---|
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Change in Hamilton Rating Scale of Depression (HAMD) From Baseline to Week 8 (Exit)
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17.5 HAMD scale units
Standard Deviation 5.2
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9 HAMD scale units
Standard Deviation 7.4
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PRIMARY outcome
Timeframe: Baseline vs. Week 8 (Exit)Population: The planned enrollment was 10 participants. One participant dropped out during Baseline II visit, thus researchers were unable to assess change from baseline to week 8 in this participant. As a results, the overall number of participants analyzed was 9.
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.
Outcome measures
| Measure |
Baseline
n=9 Participants
Baseline HAMD Score
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Week 8
n=9 Participants
Week 8 HAMD Score
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|---|---|---|
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Change in Hamilton Rating Scale of Anxiety From Baseline to Week 8 (Exit)
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15.2 HAMA units on a scale
Standard Deviation 6.4
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4.6 HAMA units on a scale
Standard Deviation 6.3
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PRIMARY outcome
Timeframe: Baseline vs. Week 8 (Exit)Population: The planned enrollment was 10 participants. One participant dropped out during Baseline II visit, thus researchers were unable to assess change from baseline to week 8 in this participant. As a result, the overall number of participants included in the analysis was 9.
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
Outcome measures
| Measure |
Baseline
n=9 Participants
Baseline HAMD Score
|
Week 8
n=9 Participants
Week 8 HAMD Score
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|---|---|---|
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Change in Quick Inventory of Depressive Symptomatology (QIDS) Score From Baseline to Week 8
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11.8 QIDS units on a scale
Standard Deviation 5.9
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5.7 QIDS units on a scale
Standard Deviation 4.5
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PRIMARY outcome
Timeframe: Baseline vs. Week 8 (Exit)Population: The planned enrollment was 10 participants. One participant dropped out during Baseline II visit, thus researchers were unable to assess change from baseline to week 8 in this participant. As a result, the overall number of participants included in the analysis was 9.
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)
Outcome measures
| Measure |
Baseline
n=9 Participants
Baseline HAMD Score
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Week 8
n=9 Participants
Week 8 HAMD Score
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|---|---|---|
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Change in Number of Standard Drinks of Alcohol Per Week Baseline vs. Week 8 (Exit)
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38.8 Drinks per week
Standard Deviation 45.9
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10.3 Drinks per week
Standard Deviation 8.2
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PRIMARY outcome
Timeframe: Baseline vs. Week 8 (Exit)Population: The planned enrollment was 10 participants. One participant dropped out during Baseline II visit, thus researchers were unable to assess change from baseline to week 8 in this participant. As a result, the overall number of participants included in the analysis was 9.
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.
Outcome measures
| Measure |
Baseline
n=9 Participants
Baseline HAMD Score
|
Week 8
n=9 Participants
Week 8 HAMD Score
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|---|---|---|
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Change in Number of Heavy Drinking Days From Baseline to Week 8 (Exit)
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3.2 Days Per Week
Standard Deviation 2.0
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1.2 Days Per Week
Standard Deviation 1.2
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PRIMARY outcome
Timeframe: Baseline vs. Week 8 (Exit)Population: The planned enrollment was 10 participants. One participant dropped out during Baseline II visit, thus researchers were unable to assess change from baseline to week 8 in this participant. As a result, the overall number of participants included in the analysis was 9.
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).
Outcome measures
| Measure |
Baseline
n=9 Participants
Baseline HAMD Score
|
Week 8
n=9 Participants
Week 8 HAMD Score
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|---|---|---|
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Change in Days of Alcohol Use From Baseline to Week 8 (Exit)
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4.1 Days Per Week
Standard Deviation 2.4
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3.3 Days Per Week
Standard Deviation 1.0
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PRIMARY outcome
Timeframe: Baseline vs. Week 8 (Exit)Population: The planned enrollment was 10 participants. One participant dropped out during Baseline II visit, thus researchers were unable to assess change from baseline to week 8 in this participant. As a result, the overall number of participants included in the analysis was 9.
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.
Outcome measures
| Measure |
Baseline
n=9 Participants
Baseline HAMD Score
|
Week 8
n=9 Participants
Week 8 HAMD Score
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|---|---|---|
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Change in Young Mania Rating Scale (YMRS) From Baseline to Week 8 (Exit)
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8.8 YMRS units on a scale
Standard Deviation 7.0
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3.3 YMRS units on a scale
Standard Deviation 3.5
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Adverse Events
Icariin
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
E. Sherwood Brown, MD, PhD
University of Texas Southwestern Medical Center
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place