Inositol in Trichotillomania

• Status: Completed
• Trial end date: 2016-05-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Chicago
• Treatments: Inositol

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