Milk Thistle in Body Dysmorphic Disorder

Study Overview
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Brief Summary
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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
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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.

Official Title
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Silymarin Treatment of Body Dysmorphic Disorder: A Double-Blind, Placebo-Controlled, Cross-Over Study

Conditions
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Body Dysmorphic Disorder

Intervention / Treatment
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* Drug: Milk Thistle
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Silymarin (Milk Thistle)<br>Each subject will have a 4 week treatment phase with milk thistle. | Drug: Milk Thistle<br> <br> * Other names: Silymarin;|
| Placebo Comparator: Placebo<br>4 week placebo phase before or after milk thistle phase depending on randomization. | Drug: Placebo<br> <br> * Other names: Sugar Pill;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Yale Brown Obsessive Compulsive Scale Modified for Body Dysmorphic Disorder (BDD-YBOCS) | 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. | Baseline and 9 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical Global Impression- Severity and Improvement (CGI) | 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. | Baseline and 9 weeks | 
| Sheehan Disability Scale (SDS) | 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) | Baseline and 9 weeks | 
| Hamilton Anxiety Rating Scale (HAM-A) | 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. | Baseline and 9 weeks | 
| Hamilton Depression Rating Scale (HAM-D) | 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. | Baseline and 9 weeks |