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Trial record 1 of 25 for:    "Trichotillomania"
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Inositol in Trichotillomania

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2014 by University of Chicago
Sponsor:
Information provided by (Responsible Party):
University of Chicago
ClinicalTrials.gov Identifier:
NCT01875445
First received: June 7, 2013
Last updated: July 7, 2014
Last verified: July 2014
  Purpose

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.


Condition Intervention Phase
Trichotillomania
Hair Pulling
Drug: Inositol
Drug: Placebo
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Double-Blind, Placebo-Controlled Study of Inositol in Trichotillomania

Resource links provided by NLM:


Further study details as provided by University of Chicago:

Primary Outcome Measures:
  • The NIMH Trichotillomania Scales Trichotillomania Symptom Severity Scale (NIMH-TSS) [ Time Frame: Once every two weeks for the 10 weeks of the study ] [ Designated as safety issue: No ]
    The entire study for an individual subject will last 10 weeks. Every 2 weeks the subject will take the NIMH-TSS for the duration of the 10 weeks. At each of these visits the outcome will be assessed. The scale itself asses severity of hair pulling.


Secondary Outcome Measures:
  • The Massachusetts General Hospital (MGH) Hairpulling Scale [ Time Frame: Once every two weeks for the 10 weeks of the study ] [ Designated as safety issue: No ]
    The entire study for an individual subject will last 10 weeks. Every 2 weeks the subject will take the MGH Hairpulling Scale for the duration of the 10 weeks. At each of these visits the outcome will be assessed. The scale itself asses severity of hair pulling.


Estimated Enrollment: 50
Study Start Date: May 2013
Estimated Primary Completion Date: May 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Placebo
Matched dosage of inositol daily.
Drug: Placebo
Taken as 2g of powder TID for 2 weeks, then 4g of powder TID for 2 weeks and then 6g of powder TID for the remainder of the study.
Other Name: Sugar Pill
Active Comparator: Inositol
Powder form, 2g TID up to 6g TID
Drug: Inositol
Taken as 2g of powder TID for 2 weeks, then 4g of powder TID for 2 weeks and then 6g of powder TID for the remainder of the study.
Other Name: Inositol Powder

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.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01875445

Contacts
Contact: Eric Leppink 773-834-3778 eleppink@uchicago.edu

Locations
United States, Illinois
University of Chicago Recruiting
Chicago, Illinois, United States, 60637
Contact: Jon E Grant, M.D., J.D., M.P.H.    773-834-1325      
Principal Investigator: Jon E Grant, MD, JD, MPH         
Sponsors and Collaborators
University of Chicago
Investigators
Principal Investigator: Jon E Grant, MD,JD,MPH University of Chicago
  More Information

No publications provided

Responsible Party: University of Chicago
ClinicalTrials.gov Identifier: NCT01875445     History of Changes
Other Study ID Numbers: 2013InositolTTM
Study First Received: June 7, 2013
Last Updated: July 7, 2014
Health Authority: United States: Food and Drug Administration
United States: Institutional Review Board

Keywords provided by University of Chicago:
Inositol
Trichotillomania
Hair Pulling
Impulse Control Disorder

Additional relevant MeSH terms:
Trichotillomania
Impulse Control Disorders
Mental Disorders
Inositol
Growth Substances
Micronutrients
Pharmacologic Actions
Physiological Effects of Drugs
Vitamin B Complex
Vitamins

ClinicalTrials.gov processed this record on November 20, 2014