Study of Icariin for Bipolar Disorder and Co-Occurring Substance Use Disorders
Condition: Bipolar Disorder; Substance Use Disorder
MeSH terms: Substance-Related Disorders; Bipolar Disorder
Study type: Interventional
Phase: Phase 3

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.
    

Intervention name(s): Icariin
Intervention type(s): Drug
Intervention description(s): 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.
Other intervention name(s): Epimedium, Horny Goat Weed, Yin Yang Huo
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment