Milk Thistle in Trichotillomania in Children and Adults

Completed · Phase 2 · Has a placebo group

Conditions studied: Trichotillomania, Hair Pulling Disorder

In brief

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

Key facts

Study ID

NCT02473913

Run by

University of Chicago

People needed

22

Starts

2015-03-01

Expected to finish

2020-09-01

Last updated by the study team

2020-11-20

Who can join

Age: 10 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Males and females ages 10-65.
• Diagnosis of current trichotillomania (TTM) based on DSM-5 criteria and confirmed using the clinician-administered Structured Clinical Interview for DSM-5 (SCID);
• Hair-pulling behavior within 2 weeks prior to enrollment;
• Child able and willing to provide active assent for participation;
• Legal guardian available to provide consent for participation.

You may not qualify if…

• Infrequent hair-pulling (i.e. less than one time per week) that does not meet DSM-5 criteria for trichotillomania;
• Unstable medical illness as determined by the investigator;
• History of seizures;
• Current use of stimulants coinciding with onset or exacerbation of trichotillomania symptoms or other current medications coinciding with exacerbation or onset or trichotillomania symptoms;
• Clinically significant suicidality (defined by the Columbia Suicide Severity Rating Scale);
• Baseline score of ≥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 or behavior therapy within 3 months prior to study baseline;
• Previous treatment with milk thistle;
• Any history of psychiatric hospitalization in the past year.

Where it is running

• University of Chicago — Chicago, Illinois, United States

Full record on ClinicalTrials.gov

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