Inositol in Trichotillomania

NCT ID: NCT01875445

Last Updated: 2023-02-23

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 38 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-05-31
• Study Completion Date: 2016-05-31

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.

Conditions

Trichotillomania; Hair Pulling

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Placebo

Matched dosage of inositol daily.

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Taken as 2g of powder TID for 2 weeks, then 4g of powder TID for 2 weeks and then 6g of powder TID for the remainder of the study.

Inositol

Powder form, 2g TID up to 6g TID

Group Type: ACTIVE_COMPARATOR

Inositol

Intervention Type: DRUG

Taken as 2g of powder TID for 2 weeks, then 4g of powder TID for 2 weeks and then 6g of powder TID for the remainder of the study.

Interventions

Inositol

Taken as 2g of powder TID for 2 weeks, then 4g of powder TID for 2 weeks and then 6g of powder TID for the remainder of the study.

Intervention Type: DRUG

Placebo

Taken as 2g of powder TID for 2 weeks, then 4g of powder TID for 2 weeks and then 6g of powder TID for the remainder of the study.

Intervention Type: DRUG

Other Intervention Names

Inositol Powder; Sugar Pill

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Chicago

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jon E Grant, MD,JD,MPH

Role: PRINCIPAL_INVESTIGATOR

University of Chicago

Locations

University of Chicago

Chicago, Illinois, United States

Countries

United States

References

Hoffman J, Williams T, Rothbart R, Ipser JC, Fineberg N, Chamberlain SR, Stein DJ. Pharmacotherapy for trichotillomania. Cochrane Database Syst Rev. 2021 Sep 28;9(9):CD007662. doi: 10.1002/14651858.CD007662.pub3.

Reference Type: DERIVED

PMID: 34582562 (View on PubMed)

Other Identifiers

2013InositolTTM

Identifier Type: -

Identifier Source: org_study_id