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

Bipolar Disorder Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01979133
• Other study ID #: 082013-042
• 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

Related Conditions & MeSH terms

• Bipolar Disorder
• Disease
• Substance Use Disorder
• Substance-Related Disorders

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