Milk Thistle in Trichotillomania in Children and Adults

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Brief Title

Milk Thistle in Trichotillomania in Children and Adults

Official Title

Silymarin Treatment of Trichotillomania in Children and Adults: A Double-Blind, Placebo-Controlled, Cross-Over Study

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.
    

Detailed Description

      Pathological hair-pulling, trichotillomania, has been defined as repetitive, intentionally
      performed pulling that causes noticeable hair loss and results in clinically significant
      distress or functional impairment. Trichotillomania appears relatively common with an
      estimated prevalence between 1-3%. Data on the pharmacological treatment of trichotillomania
      is limited to case reports and conflicting double-blind studies of serotonin reuptake
      inhibitors. One positive double-blind study of N-acetyl cysteine in adults was not successful
      when examined for children and adolescents. Available data on the treatment of
      trichotillomania in children are therefore limited.

      Silymarin, a flavonoid and a member of the Asteraceae family, is extracted from the seeds of
      milk thistle (Silybum marianum) and is known to have antioxidative and anti-apoptotic
      properties. Furthermore, it has been demonstrated that its anti-oxidative activity is related
      to the scavenging of free radicals and activation of anti-oxidative defenses: increases in
      cellular glutathione content and superoxide dismutase activity. Milk thistle has been used
      for a range of psychiatric disorders including methamphetamine abuse and obsessive compulsive
      disorder. The flavonoid complex silymarin in preclinical studies has been found to increase
      serotonin and dopamine levels in the cortex. In the frontal cortex one of the functions of
      dopamine is to increase the signal to noise ratio, increased dopamine correlating with
      increased frontal performance. Studies have shown that the higher cortical dopamine levels
      are associated with improved frontal cortical cognitive performance. Cortical inhibition is
      felt to be the basis for top-down control of motivated behaviors. A recent randomized
      controlled study with milk thistle was conducted in Iran Thirty five participants with
      moderate OCD were randomly assigned to 200 mg of milk thistle leaf extract or 10 mg of
      fluoxetine three times daily for eight weeks. Results revealed no significant difference in
      treatment effects between milk thistle and fluoxetine from baseline to endpoint as both
      interventions provided a highly significant reduction in symptoms. Silymarin or Milk Thistle
      may therefore offer promise for the treatment of individuals with trichotillomania.

      The current pilot study examines the tolerability and efficacy of milk thistle in the
      treatment of trichotillomania in children and adults. The investigators hypothesize that milk
      thistle will reduce the severity of symptoms related to trichotillomania and improve
      patients' overall functioning.
    

Study Phase

Phase 2

Study Type

Interventional


Primary Outcome

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

Secondary Outcome

 Massachusetts General Hospital Hair Pulling Scale (MGH-HPS)

Condition

Trichotillomania

Intervention

Milk Thistle

Study Arms / Comparison Groups

 Milk Thistle
Description:  Each subject will have a 6 week treatment phase with milk thistle.

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Drug

Estimated Enrollment

22

Start Date

March 2015

Completion Date

September 2020

Primary Completion Date

June 2018

Eligibility 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.
      

Gender

All

Ages

10 Years - 65 Years

Accepts Healthy Volunteers

No

Contacts

Jon E Grant, JD, MD, MPH, , 

Location Countries

United States

Location Countries

United States

Administrative Informations


NCT ID

NCT02473913

Organization ID

15-0178


Responsible Party

Sponsor

Study Sponsor

University of Chicago


Study Sponsor

Jon E Grant, JD, MD, MPH, Principal Investigator, University of Chicago


Verification Date

November 2020