Milk Thistle in Body Dysmorphic Disorder

• Status: Recruiting
• Trial end date: 2021-10-01
• Target enrollment: 0
• Participant gender: All

Summary

The proposed study will consist of a 9 week double-blind cross-over study trial of milk thistle in 15 people (ages 18-65). The study will be divided into an initial 4 week phase, a one week wash out phase, and a second 4 week phase, with one of the 4 week phases consisting of active treatment with milk thistle, and the other 4 week phase consisting of inactive placebo treatment. Participants will be randomized to receive either milk thistle or placebo during the first 4 week phase on a 1:1 basis. This blinding will be maintained by the IDS pharmacy at the University of Chicago.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Chicago
• Treatments: Silymarin

Criteria

Inclusion Criteria:

• Males and females age 18-65

• Diagnosis of current body dysmorphic disorder (BDD) based on DSM-5 criteria and confirmed using the clinician-administered Structural Clinical Interview for DSM-5 (SCID)

• Able and willing to provide written consent for participation

Exclusion Criteria:

• Unstable medical illness as determined by the investigator

• History of seizures

• Clinically significant suicidality (defined by the Columbia Suicide Severity Rating Scale)

• Baseline score greater than or equal to 17 on the Hamilton Depression Rating Scale (17-item HDRS)

• Lifetime history of bipolar disorder type I or II, schizophrenia, autism, any psychotic disorder, or any substance use disorder

• Initiation of psychotherapy of behavior therapy within 3 months prior to study baseline

• Previous treatment with milk thistle

• Any history of psychiatric hospitalization in the past year

• Currently pregnant (confirmed by urine pregnancy test)