Phase 2
N=22
Milk Thistle in Trichotillomania in Children and Adults
Trichotillomania · Hair Pulling Disorder
Bottom Line
View on ClinicalTrials.gov: NCT02473913 ↗Enrolled (actual)
22
Serious AEs
0.0%
Results posted
Nov 2020
Primary outcome: Primary: Change in NIMH Trichotillomania Severity Scale (NIMH-TSS) Scores — 9.4; 9.4; 6.3; 7.4 score on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Milk Thistle (Drug); Placebo (Drug)
- Age
- Pediatric, Adult, Older Adult · 10+ yrs
- Sex
- All
- Sponsor
- University of Chicago
- Primary completion
- Jun 2018
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in NIMH Trichotillomania Severity Scale (NIMH-TSS) Scores |
9.4; 9.4; 6.3; 7.4 | — |
| SECONDARY Massachusetts General Hospital Hair Pulling Scale (MGH-HPS) |
13.5; 14.7; 10.4; 12.3 | — |
| SECONDARY Clinical Global Impression- Severity and Improvement (CGI) |
4.1; 3.9; 3.0; 3.6 | — |
| SECONDARY Sheehan Disability Scale (SDS) |
8.8; 8.8; 5.2; 5.9 | — |
| SECONDARY Hamilton Anxiety Rating Scale (HAM-A) |
4.9; 5.1; 2.8; 3.4 | — |
| SECONDARY Hamilton Depression Rating Scale (HAM-D) |
5.7; 5.5; 2.7; 2.9 | — |
| SECONDARY Trichotillomania Scale for Children/Parent (TSC-C & TSC-P) |
2.9; 2.0; 1.7; 1.7; 2.5; 1.9 | — |
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.
Eligibility Criteria
Inclusion Criteria
- 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.
Exclusion Criteria
- 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.
Data sourced from ClinicalTrials.gov (NCT02473913). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.