Milk Thistle in Trichotillomania in Children and Adults

• Status: Completed
• Trial end date: 2020-09-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Chicago
• Treatments: Silymarin

Criteria

Inclusion Criteria:

1. Males and females ages 10-65.

2. Diagnosis of current trichotillomania (TTM) based on DSM-5 criteria and confirmed using the clinician-administered Structured Clinical Interview for DSM-5 (SCID);

3. Hair-pulling behavior within 2 weeks prior to enrollment;

4. Child able and willing to provide active assent for participation;

5. Legal guardian available to provide consent for participation.

Exclusion Criteria:

1. Infrequent hair-pulling (i.e. less than one time per week) that does not meet DSM-5 criteria for trichotillomania;

2. Unstable medical illness as determined by the investigator;

3. History of seizures;

4. Current use of stimulants coinciding with onset or exacerbation of trichotillomania symptoms or other current medications coinciding with exacerbation or onset or trichotillomania symptoms;

5. Clinically significant suicidality (defined by the Columbia Suicide Severity Rating Scale);

6. Baseline score of ≥17 on the Hamilton Depression Rating Scale (17-item HDRS);

7. Lifetime history of bipolar disorder type I or II, schizophrenia, autism, any psychotic disorder, or any substance use disorder;

8. Initiation of psychotherapy or behavior therapy within 3 months prior to study baseline;

9. Previous treatment with milk thistle;

10. Any history of psychiatric hospitalization in the past year.