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

Study ID
STU 082013-042

Cancer Related
No

Healthy Volunteers
No

Study Sites

Contact
Kendra Malone
469/569-0168
kendra.malone@utsouthwestern.edu

Principal Investigator
Edson Brown

Summary

We propose an 8 week open label, proof of concept study in ten adult outpatients with current bipolar disorder and cocaine and/or alcohol use disorders. as the proposed study is open-label, no blinding will be needed. Participants will have depressive sysmptoms assessed by the Hamilton Rating Scale for Depression (HaMD) and Quick inventory of Depressive Symptomatology - Self Report (QiDS-SR). Mania will be assessed by the Young Mania Rating Scale (YMRS). anxiety symptoms will be assessed using the Hamilton Rating Scale for anxiety (HaMa). Substance use will be assessed using the Timeline Follow Back (TLFB) method and urine drug screens. Safety and tolerability will be assessed by PRD-iii Side effect scale and physician follow-ups. Cognition will be assessed by a neurocognitive battery including the RaVLT, RMCPT, and TMT.

Participant Eligibility


* Current BPD I, II or NOS and cocaine or alcohol use disorder with HAMD score of >= 12

* Cocaine or alcohol use with 5 days of initiating study drug

* Men and women

* Age 18-70 years