Milk Thistle in Trichotillomania in Children and Adults

NCT02473913 | Completed Phase 2 Results DMC

• 1 other identifier: 15-0178
• Study Type: interventional
• Target: 22
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Trichotillomania; Hair Pulling Disorder

Outcome Measures

Primary Outcomes (1)

• Change in NIMH Trichotillomania Severity Scale (NIMH-TSS) Scores

  The entire study for the subject will last 13 weeks. Every two weeks and after the one week washout period the subject will take the NIMH-Trichotillomania Symptom Severity Scale (NIMH-TSS). The change in scores from baseline to after 13 weeks will be assessed. The NIMH-TSS consists of 5 questions related to the following aspects of TTM: average time spent pulling, time spent pulling on the previous day, resistance to urges, resulting distress and daily interference. NIMH-TSS scores range from 0 to 25, with higher scores indicating higher severity.

  Baseline and 13 weeks

Secondary Outcomes (6)

• Massachusetts General Hospital Hair Pulling Scale (MGH-HPS)

  Up to 13 weeks

• Clinical Global Impression- Severity and Improvement (CGI)

  Up to 13 weeks

• Sheehan Disability Scale (SDS)

  Up to 13 weeks

• Hamilton Anxiety Rating Scale (HAM-A)

  Up to 13 weeks

• Hamilton Depression Rating Scale (HAM-D)

  Up to 13 weeks

Study Arms (2)

Milk Thistle

EXPERIMENTAL

Each subject will have a 6 week treatment phase with milk thistle.

Drug: Milk Thistle

Placebo

PLACEBO COMPARATOR

6 week placebo phase before or after milk thistle phase depending on randomization.

Drug: Placebo

Interventions

Milk Thistle DRUG

Also known as: Silymarin

Milk Thistle

Placebo DRUG

Also known as: Sugar Pill

Placebo

Eligibility Criteria

• Age: 10 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

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.

Sponsors & Collaborators

• University of Chicago: lead

Study Sites (1)

University of Chicago

Chicago, Illinois, 60637, United States

Location

MeSH Terms

Conditions

Trichotillomania

Interventions

milk-thistle extract; Silymarin; Sugars

Condition Hierarchy (Ancestors)

Obsessive-Compulsive Disorder; Anxiety Disorders; Mental Disorders; Disruptive, Impulse Control, and Conduct Disorders

Intervention Hierarchy (Ancestors)

Flavonolignans; Flavonoids; Chromones; Benzopyrans; Pyrans; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Carbohydrates

Results Point of Contact

• Title: Stephanie Valle
• Organization: University of Chicago

svalle@yoda.bsd.uchicago.edu

773-834-3778

Study Officials

• Jon E Grant, JD, MD, MPH

  University of Chicago

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 2, 2015
• First Posted: June 17, 2015
• Study Start: March 1, 2015
• Primary Completion: June 1, 2018
• Study Completion: September 1, 2020
• Last Updated: November 20, 2020
• Results First Posted: November 4, 2020

Record last verified: 2020-11

Locations

US (1)