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Milk Thistle in Body Dysmorphic Disorder

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02843451
Recruitment Status : Recruiting
First Posted : July 25, 2016
Last Update Posted : February 5, 2020
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Body Dysmorphic Disorder Drug: Milk Thistle Drug: Placebo Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 15 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Silymarin Treatment of Body Dysmorphic Disorder: A Double-Blind, Placebo-Controlled, Cross-Over Study
Actual Study Start Date : October 2016
Estimated Primary Completion Date : October 2020
Estimated Study Completion Date : October 2020


Arm Intervention/treatment
Experimental: Silymarin (Milk Thistle)
Each subject will have a 4 week treatment phase with milk thistle.
Drug: Milk Thistle
Other Name: Silymarin

Placebo Comparator: Placebo
4 week placebo phase before or after milk thistle phase depending on randomization.
Drug: Placebo
Other Name: Sugar Pill




Primary Outcome Measures :
  1. Yale Brown Obsessive Compulsive Scale Modified for Body Dysmorphic Disorder (BDD-YBOCS) [ Time Frame: 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 :
  1. Clinical Global Impression- Severity and Improvement (CGI) [ Time Frame: 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.

  2. Sheehan Disability Scale (SDS) [ Time Frame: 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)

  3. Hamilton Anxiety Rating Scale (HAM-A) [ Time Frame: 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.

  4. Hamilton Depression Rating Scale (HAM-D) [ Time Frame: 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02843451


Contacts
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Contact: Sarah Redden, BA 7737029066 sredden@uchicago.edu

Locations
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United States, Illinois
University of Chicago Recruiting
Chicago, Illinois, United States, 60637
Contact: Stephanie Valle, BA    773-834-1325    svalle@yoda.bsd.uchicago.edu   
Contact: Jon E Grant, JD, MD, MPH    7738341325    jongrant@uchicago.edu   
Sponsors and Collaborators
University of Chicago
Investigators
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Principal Investigator: Jon E Grant, JD, MD, MPH University of Chicago
Publications:

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Responsible Party: University of Chicago
ClinicalTrials.gov Identifier: NCT02843451    
Other Study ID Numbers: 16-0642
First Posted: July 25, 2016    Key Record Dates
Last Update Posted: February 5, 2020
Last Verified: January 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Additional relevant MeSH terms:
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Body Dysmorphic Disorders
Somatoform Disorders
Mental Disorders
Silymarin
Antioxidants
Molecular Mechanisms of Pharmacological Action
Protective Agents
Physiological Effects of Drugs