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 Information
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
Administrative Informations
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