Psoriasis Clinical Trial

Inositol in Trichotillomania

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.

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Full 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.

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Eligibility Criteria

Inclusion Criteria:

Age 18-65 years
Trichotillomania (TTM) as the primary psychiatric diagnosis
Women's participation required negative results on a beta-human chorionic gonadotropin pregnancy test and stable use of a medically accepted form of contraception.
Signed informed consent before entry into the study.

Exclusion Criteria:

Unstable medical illness or clinically significant abnormalities on laboratory tests or physical examination at screening visit
Current pregnancy or lactation, or inadequate contraception in women of childbearing potential
A need for medication other than ecopipam with possible psychotropic effects
Lifetime history of bipolar disorder type I or II, dementia, or schizophrenia as determined by the Structured Clinical Interview for DSM-IV
Current (past 12-months) DSM-IV substance abuse or dependence
Positive urine drug screen at screening
Initiation of cognitive behavior therapy within 3 months prior to study baseline
Baseline score of ≥17 on the Hamilton Depression Rating Scale (17-item HDRS
Any suicidality based on clinical interview
History of head injury or neurological disorder (such as seizures)
Any history of psychiatric hospitalization in the past year
Any history of a suicide attempt

Study is for people with:

Psoriasis

Phase:

Phase 2

Estimated Enrollment:

38

Study ID:

NCT01875445

Recruitment Status:

Completed

Sponsor:

University of Chicago

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There is 1 Location for this study

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University of Chicago
Chicago Illinois, 60637, United States

How clear is this clinincal trial information?

Study is for people with:

Psoriasis

Phase:

Phase 2

Estimated Enrollment:

38

Study ID:

NCT01875445

Recruitment Status:

Completed

Sponsor:


University of Chicago

How clear is this clinincal trial information?

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