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

NCT ID: NCT01979133

Last Updated: 2017-04-19

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 10 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-10-31
• Study Completion Date: 2015-06-30

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.

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.

Conditions

Bipolar Disorder; Substance Use Disorder

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Icariin

Intervention Type: 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.

Interventions

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.

Intervention Type: DRUG

Other Intervention Names

Epimedium, Horny Goat Weed, Yin Yang Huo

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Texas Southwestern Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Sherwood Brown

E. Sherwood Brown, M.D., Ph.D., Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Edson S Brown, M.D., Ph.D.

Role: PRINCIPAL_INVESTIGATOR

UT Southwestern Medical Center

Locations

The University of Texas Southwestern Medical Center

Dallas, Texas, United States

Countries

United States

Other Identifiers

082013-042

Identifier Type: -

Identifier Source: org_study_id