Inositol in Trichotillomania

Phase 2

Completed

• Conditions: Trichotillomania; Hair Pulling
• Interventions: Drug: Placebo; Drug: Inositol

• Registration Number: NCT01875445
• Lead Sponsor: University of Chicago

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 Timeline

• Study Start: 2013-05
• Study First Submitted: 2013-06-07
• Study First Submitted QC: 2013-06-07
• Study First Posted: 2013-06-11
• Primary Completion: 2016-05
• Study Completion: 2016-05
• Results First Submitted: 2017-02-27
• Results First Submitted QC: 2017-04-10
• Results First Posted: 2017-05-19
• Status Verified: 2023-02
• Last Update Submitted: 2023-02-21
• Last Update Posted: 2023-02-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 38

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	Matched dosage of inositol daily.
Inositol	Inositol	Powder form, 2g TID up to 6g TID

Primary Outcome Measures

Name	Time	Method
The National Institute of Mental Health Trichotillomania Symptom Severity Scale (NIMH-TSS)	Once every two weeks for the 10 weeks of the study	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, but only baseline and final values will be used for general final outcome assessment. The scale itself asses severity of hair pulling.

Secondary Outcome Measures

Name	Time	Method
The Massachusetts General Hospital (MGH) Hairpulling Scale	Once every two weeks for the 10 weeks of the study	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, baseline and final visits will be use for general final outcome assessment. The scale itself asses severity of hair pulling.

Trial Locations

Locations (1)

University of Chicago; 🇺🇸 Chicago, Illinois, United States