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Milk Thistle in Trichotillomania in Children and Adults

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ClinicalTrials.gov Identifier: NCT02473913
Recruitment Status : Active, not recruiting
First Posted : June 17, 2015
Last Update Posted : January 21, 2019
Sponsor:
Information provided by (Responsible Party):
University of Chicago

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.

Condition or disease Intervention/treatment Phase
Trichotillomania Hair Pulling Disorder Drug: Milk Thistle Drug: Placebo Phase 2

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 14 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Silymarin Treatment of Trichotillomania in Children and Adults: A Double-Blind, Placebo-Controlled, Cross-Over Study
Study Start Date : March 2015
Actual Primary Completion Date : June 2018
Estimated Study Completion Date : June 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Milk Thistle
Each subject will have a 6 week treatment phase with milk thistle.
Drug: Milk Thistle
Other Name: Silymarin

Placebo Comparator: Placebo
6 week placebo phase before or after milk thistle phase depending on randomization.
Drug: Placebo
Other Name: Sugar Pill




Primary Outcome Measures :
  1. Change in NIMH Trichotillomania Severity Scale (NIMH-TSS) Scores [ Time Frame: Baseline and 13 weeks ]
    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-TSS. The change in scores from baseline to after 13 weeks will be assessed. The scale itself assesses severity of trichotillomania.


Secondary Outcome Measures :
  1. Massachusetts General Hospital Hair Pulling Scale (MGH-HPS) [ Time Frame: Up to 13 weeks ]
    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 MGH-HPS. At each of these visits the outcome will be assessed. The scale itself assesses severity of trichotillomania.

  2. Clinical Global Impression- Severity and Improvement (CGI) [ Time Frame: Up to 13 weeks ]
    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 CGI. At each of these visits the outcome will be assessed. The scale itself assesses overall disorder severity.

  3. Sheehan Disability Scale (SDS) [ Time Frame: Up to 13 weeks ]
    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 SDS. At each of these visits the outcome will be assessed. The scale itself assesses the level of disability from trichotillomania (or target disorder).

  4. Hamilton Anxiety Rating Scale (HAM-A) [ Time Frame: Up to 13 weeks ]
    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 HAM-A. At each of these visits the outcome will be assessed. The scale itself assesses level of anxiety.

  5. Hamilton Depression Rating Scale (HAM-D) [ Time Frame: Up to 13 weeks ]
    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 HAM-D. At each of these visits the outcome will be assessed. The scale itself assesses level of depression.

  6. Trichotillomania Scale for Children (TSC-C & TSC-P) [ Time Frame: Up to 13 weeks ]
    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 TSC-C. At each of these visits the outcome will be assessed. The scale itself assesses severity of trichotillomania.



Information from the National Library of Medicine

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Ages Eligible for Study:   10 Years to 65 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02473913


Locations
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United States, Illinois
University of Chicago
Chicago, Illinois, United States, 60637
Sponsors and Collaborators
University of Chicago
Investigators
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Principal Investigator: Jon E Grant, JD, MD, MPH University of Chicago

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Responsible Party: University of Chicago
ClinicalTrials.gov Identifier: NCT02473913     History of Changes
Other Study ID Numbers: 15-0178
First Posted: June 17, 2015    Key Record Dates
Last Update Posted: January 21, 2019
Last Verified: October 2018
Additional relevant MeSH terms:
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Trichotillomania
Disruptive, Impulse Control, and Conduct Disorders
Mental Disorders
Silymarin
Antioxidants
Molecular Mechanisms of Pharmacological Action
Protective Agents
Physiological Effects of Drugs