Milk Thistle in Body Dysmorphic Disorder

Phase 2

Withdrawn

• Conditions: Body Dysmorphic Disorder
• Interventions: Drug: Placebo; Drug: Milk Thistle

• Registration Number: NCT02843451
• Lead Sponsor: University of Chicago

Brief 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.

Detailed Description

The goal of the proposed study is to evaluate the efficacy and safety of silymarin (milk thistle) in adults with body dysmorphic disorder. The hypothesis to be tested is that silymarin will be more effective and well tolerated in adults with body dysmorphic disorder compared to placebo. The proposed study will provide needed data on the treatment of a disabling disorder that currently lacks a clearly effective treatment.

The primary aim of this application is to conduct a randomized placebo-controlled pharmacotherapy trial using silymarin (milk thistle) in 15 participants with body dysmorphic disorder. The study will consist of three phases: a 4 week active treatment phase with milk thistle, a 4 week placebo phase, and a one week wash out phase between the active and placebo phases. The subjects will be randomized to either receive active or placebo treatment in the first 4 weeks, and the other during the remaining 4 week phase.

This will be one of few studies assessing the use of pharmacotherapy for the treatment of body dysmorphic disorder in adults. Assessing the efficacy and safety of silymarin (milk thistle), will help inform clinicians about additional treatment options for adults suffering from this disorder.

Study Timeline

• Study First Submitted: 2016-07-21
• Study First Submitted QC: 2016-07-21
• Study First Posted: 2016-07-25
• Study Start: 2016-10
• Status Verified: 2022-12
• Last Update Submitted: 2022-12-23
• Last Update Posted: 2022-12-28
• Primary Completion: 2023-10
• Study Completion: 2023-10

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	4 week placebo phase before or after milk thistle phase depending on randomization.
Silymarin (Milk Thistle)	Milk Thistle	Each subject will have a 4 week treatment phase with milk thistle.

Primary Outcome Measures

Name	Time	Method
Yale Brown Obsessive Compulsive Scale Modified for Body Dysmorphic Disorder (BDD-YBOCS)	Baseline and 9 weeks	The entire study for the subject will last 9 weeks. Every four weeks and after the one week washout period the subject will take the BDD-YBOCS. The change in scores from baseline to after 9 weeks will be assessed. The scale itself assesses severity of body dysmorphic disorder symptoms.

Secondary Outcome Measures

Name	Time	Method
Clinical Global Impression- Severity and Improvement (CGI)	Baseline and 9 weeks	The entire study for the subject will last 9 weeks. Every four weeks and after the one week washout period the subject will complete the CGI. The change in scores from baseline to after 9 weeks will be assessed. The scale itself assesses overall disorder severity.
Hamilton Anxiety Rating Scale (HAM-A)	Baseline and 9 weeks	The entire study for the subject will last 9 weeks. Every four weeks and after the one week washout period the subject will complete the HAM-A. The change in scores from baseline to after 9 weeks will be assessed. The scale itself assesses level of anxiety.
Hamilton Depression Rating Scale (HAM-D)	Baseline and 9 weeks	The entire study for the subject will last 9 weeks. Every four weeks and after the one week washout period the subject will complete the HAM-D. The change in scores from baseline to after 9 weeks will be assessed. The scale itself assesses level of depression.
Sheehan Disability Scale (SDS)	Baseline and 9 weeks	The entire study for the subject will last 9 weeks. Every four weeks and after the one week washout period the subject will complete the SDS. The change in scores from baseline to after 9 weeks will be assessed. The scale itself assesses the level of disability from body dysmorphic disorder (or target disorder)

Trial Locations

Locations (1)

University of Chicago; 🇺🇸 Chicago, Illinois, United States