Inositol in Trichotillomania

Brief Title

Inositol in Trichotillomania

Official Title

A Double-Blind, Placebo-Controlled Study of Inositol in Trichotillomania

Brief Summary

      The purpose of this study is to evaluate the safety and effectiveness of inositol for the
      treatment of compulsive hair pulling, also known as trichotillomania. Inositol is used for
      diabetic nerve pain, panic disorder, high cholesterol, insomnia, cancer, depression,
      schizophrenia, Alzheimer's disease, attention deficit-hyperactivity disorder (ADHD), autism,
      promoting hair growth, a skin disorder called psoriasis, and treating side effects of medical
      treatment with some medications, including lithium. The hypothesis to be tested is that
      Inositol will be effective and well tolerated in patients with trichotillomania compared to
      placebo. The proposed study will provide needed data on the treatment of the 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 (1). Trichotillomania appears relatively common with an
      estimated prevalence between 1-3% (2). Data on the pharmacological treatment of
      trichotillomania is limited to case reports and conflicting double-blind studies of serotonin
      reuptake inhibitors (3).

      Inositol is used for diabetic nerve pain, panic disorder, high cholesterol, insomnia, cancer,
      depression, schizophrenia, Alzheimer's disease, attention deficit-hyperactivity disorder
      (ADHD), autism, promoting hair growth, a skin disorder called psoriasis, and treating side
      effects of medical treatment with some medications, including lithium. A small study (n=3)
      found that subject's showed improvement while taking Inositol in both trichotillomania and
      pathological skin picking (4). This suggests that Inositol might be effective in treating a
      large sample of subjects with trichotillomania and it also suggests that it may be effective
      for impulse control disorders in general. Inositol has also been shown to be effective in
      treating obsessive compulsive disorder and showed significantly lower scores on the
      Yale-Brown Obsessive Compulsive Scale (5). Both studies indicate the effectiveness of
      Inositol in treating impulsivity and compulsivity in subjects. There is no medication
      approved by the Food and Drug Administration for trichotillomania. Inositol represents a
      potentially safe and effective treatment.
    

Study Phase

Phase 2

Study Type

Interventional

Primary Outcome

The National Institute of Mental Health Trichotillomania Symptom Severity Scale (NIMH-TSS)

Secondary Outcome

 The Massachusetts General Hospital (MGH) Hairpulling Scale

Condition

Trichotillomania

Intervention

Inositol

Study Arms / Comparison Groups

 Placebo

Description:  Matched dosage of inositol daily.

Publications

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

Recruitment Status

Drug

Estimated Enrollment

38

Start Date

May 2013

Completion Date

May 2016

Primary Completion Date

May 2016

Eligibility Criteria

        Inclusion Criteria:

          1. Age 18-65 years

          2. Trichotillomania (TTM) as the primary psychiatric diagnosis

          3. Women's participation required negative results on a beta-human chorionic gonadotropin
             pregnancy test and stable use of a medically accepted form of contraception.

          4. Signed informed consent before entry into the study.

        Exclusion Criteria:

          1. Unstable medical illness or clinically significant abnormalities on laboratory tests
             or physical examination at screening visit

          2. Current pregnancy or lactation, or inadequate contraception in women of childbearing
             potential

          3. A need for medication other than ecopipam with possible psychotropic effects

          4. Lifetime history of bipolar disorder type I or II, dementia, or schizophrenia as
             determined by the Structured Clinical Interview for DSM-IV

          5. Current (past 12-months) DSM-IV substance abuse or dependence

          6. Positive urine drug screen at screening

          7. Initiation of cognitive behavior therapy within 3 months prior to study baseline

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

          9. Any suicidality based on clinical interview

         10. History of head injury or neurological disorder (such as seizures)

         11. Any history of psychiatric hospitalization in the past year

         12. Any history of a suicide attempt
      

Gender

All

Ages

18 Years - 65 Years

Accepts Healthy Volunteers

No

Contacts

Jon E Grant, MD,JD,MPH, , 

Location Countries

United States

Location Countries

United States

NCT ID

NCT01875445

Organization ID

2013InositolTTM

Responsible Party

Principal Investigator

Study Sponsor

University of Chicago

Study Sponsor

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

Verification Date

April 2017