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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Hamilton Rating Scale of Depression (HAMD) From Baseline to Week 8 (Exit) | HAMD is an observer-rated measure of depressive symptomatology:
| 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:
| 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:
| Baseline vs. Week 8 (Exit) |
| Change in Number of Standard Drinks of Alcohol Per Week Baseline vs. Week 8 (Exit) |
|
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Edson S Brown, M.D., Ph.D. | University of Texas Southwestern Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The University of Texas Southwestern Medical Center | Dallas | Texas | 75390-8849 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Change in Hamilton Rating Scale of Depression (HAMD) From Baseline to Week 8 (Exit) | HAMD is an observer-rated measure of depressive symptomatology:
| 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. | Posted | Mean | Standard Deviation | HAMD scale units | Baseline vs. Week 8 (Exit) |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| E. Sherwood Brown, MD, PhD | University of Texas Southwestern Medical Center | 2146466948 | sherwood.brown@utsouthwestern.edu |
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| ID | Term |
|---|---|
| D001714 | Bipolar Disorder |
| D019966 | Substance-Related Disorders |
| ID | Term |
|---|---|
| D000068105 | Bipolar and Related Disorders |
| D019964 | Mood Disorders |
| D001523 | Mental Disorders |
| D064419 | Chemically-Induced Disorders |
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| ID | Term |
|---|---|
| C056599 | icariin |
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| Baseline vs. Week 8 (Exit) |
| Change in Number of Heavy Drinking Days From Baseline to Week 8 (Exit) |
| Baseline vs. Week 8 (Exit) |
| Change in Days of Alcohol Use From Baseline to Week 8 (Exit) |
| 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:
| Baseline vs. Week 8 (Exit) |
| years |
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| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| OG001 | Week 8 | Week 8 HAMD Score |
|
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| Primary | Change in Hamilton Rating Scale of Anxiety From Baseline to Week 8 (Exit) | HAMA is a 14-item observer rated measure of anxiety symptomatology:
| 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. | Posted | Mean | Standard Deviation | HAMA units on a scale | Baseline vs. Week 8 (Exit) |
|
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|
| Primary | 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:
| 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. | Posted | Mean | Standard Deviation | QIDS units on a scale | Baseline vs. Week 8 (Exit) |
|
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|
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| Primary | Change in Number of Standard Drinks of Alcohol Per Week Baseline vs. Week 8 (Exit) |
| 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. | Posted | Mean | Standard Deviation | Drinks per week | Baseline vs. Week 8 (Exit) |
|
|
|
|
| Primary | Change in Number of Heavy Drinking Days From Baseline to Week 8 (Exit) |
| 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. | Posted | Mean | Standard Deviation | Days Per Week | Baseline vs. Week 8 (Exit) |
|
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|
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| Primary | Change in Days of Alcohol Use From Baseline to Week 8 (Exit) |
| 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. | Posted | Mean | Standard Deviation | Days Per Week | Baseline vs. Week 8 (Exit) |
|
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|
|
| Primary | 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:
| 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. | Posted | Mean | Standard Deviation | YMRS units on a scale | Baseline vs. Week 8 (Exit) |
|
|
|
|
| 0 |
| 10 |
| 0 |
| 10 |
| 0 |
| 10 |
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