Inositol in Trichotillomania



Status:Recruiting
Conditions:Psychiatric
Therapuetic Areas:Psychiatry / Psychology
Healthy:No
Age Range:18 - 65
Updated:4/21/2016
Start Date:May 2013
End Date:December 2016
Contact:Eric Leppink
Email:eleppink@uchicago.edu
Phone:773-834-3778

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

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.

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.

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
We found this trial at
1
site
5801 South Ellis Avenue
Chicago, Illinois 60637
 773.702.1234
Principal Investigator: Jon E Grant, MD, JD, MPH
Phone: 773-834-1325
University of Chicago One of the world's premier academic and research institutions, the University of...
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Chicago, IL
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