Clinical trial NCT02843451: Milk Thistle in Body Dysmorphic Disorder
Official title: Silymarin Treatment of Body Dysmorphic Disorder: A Double-Blind, Placebo-Controlled, Cross-Over Study
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE2
Conditions: Body Dysmorphic Disorder
Lead sponsor: University of Chicago
Sponsor class: OTHER
First posted: 2016-07-25
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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.

Eligibility 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)

Primary outcomes:
measure: Yale Brown Obsessive Compulsive Scale Modified for Body Dysmorphic Disorder (BDD-YBOCS)
timeFrame: Baseline and 9 weeks
Secondary outcomes:
measure: Clinical Global Impression- Severity and Improvement (CGI)
timeFrame: Baseline and 9 weeks
measure: Sheehan Disability Scale (SDS)
timeFrame: Baseline and 9 weeks
measure: Hamilton Anxiety Rating Scale (HAM-A)
timeFrame: Baseline and 9 weeks
measure: Hamilton Depression Rating Scale (HAM-D)
timeFrame: Baseline and 9 weeks
Other outcomes:
Locations:
city: Chicago
country: United States
facility: University of Chicago
state: Illinois
Study officials:
affiliation: University of Chicago
name: Jon E Grant, JD, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References:
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