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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT01979133
Other study ID # 082013-042
Secondary ID
Status Recruiting
Phase Phase 3
First received October 25, 2013
Last updated January 8, 2015
Start date October 2013
Est. completion date August 2015

Study information

Verified date January 2015
Source University of Texas Southwestern Medical Center
Contact Nicholas Wignall, M.A.
Phone 214-645-6960
Email nicholas.wignall@utsouthwestern.edu
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 10
Est. completion date August 2015
Est. primary completion date July 2015
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 70 Years
Eligibility 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 Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment


Intervention

Drug:
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.

Locations

Country Name City State
United States The University of Texas Southwestern Medical Center Dallas Texas

Sponsors (1)

Lead Sponsor Collaborator
University of Texas Southwestern Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Change in Hamilton Rating Scale of Depression The HAMD, is an observer-rated measure of depressive symptomatology. weekly assessments up to 8 weeks after baseline No
Secondary Change Young Mania Rating Scale The Young Mania rating scale is an observer-rated measure of the severity of manic symptoms on a 5-9 point scale. weekly assessments up to 8 weeks after baseline No
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