Clinical trial NCT01979133: Study of Icariin for Bipolar Disorder and Co-Occurring Substance Use Disorders
Official title: A Proof of Concept Study of Icariin for Bipolar Disorder and Co-Occurring Substance Use Disorders
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Bipolar Disorder
Substance Use Disorder
Lead sponsor: University of Texas Southwestern Medical Center
Sponsor class: OTHER
First posted: 2013-11-08
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Change in Hamilton Rating Scale of Depression (HAMD) From Baseline to Week 8 (Exit)
timeFrame: Baseline vs. Week 8 (Exit)
measure: Change in Hamilton Rating Scale of Anxiety From Baseline to Week 8 (Exit)
timeFrame: Baseline vs. Week 8 (Exit)
measure: Change in Quick Inventory of Depressive Symptomatology (QIDS) Score From Baseline to Week 8
timeFrame: Baseline vs. Week 8 (Exit)
measure: Change in Number of Standard Drinks of Alcohol Per Week Baseline vs. Week 8 (Exit)
timeFrame: Baseline vs. Week 8 (Exit)
measure: Change in Number of Heavy Drinking Days From Baseline to Week 8 (Exit)
timeFrame: Baseline vs. Week 8 (Exit)
measure: Change in Days of Alcohol Use From Baseline to Week 8 (Exit)
timeFrame: Baseline vs. Week 8 (Exit)
measure: Change in Young Mania Rating Scale (YMRS) From Baseline to Week 8 (Exit)
timeFrame: Baseline vs. Week 8 (Exit)
Secondary outcomes:
Other outcomes:
Locations:
city: Dallas
country: United States
facility: The University of Texas Southwestern Medical Center
state: Texas
Study officials:
affiliation: UT Southwestern Medical Center
name: Edson S Brown, M.D., Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: