Clinical trial NCT01875445: Inositol in Trichotillomania
Official title: A Double-Blind, Placebo-Controlled Study of Inositol in Trichotillomania
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Trichotillomania
Hair Pulling
Keywords: Inositol
Trichotillomania
Hair Pulling
Impulse Control Disorder
Lead sponsor: University of Chicago
Sponsor class: OTHER
First posted: 2013-06-11
Enrollment: 38
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: The National Institute of Mental Health Trichotillomania Symptom Severity Scale (NIMH-TSS)
timeFrame: Once every two weeks for the 10 weeks of the study
Secondary outcomes:
measure: The Massachusetts General Hospital (MGH) Hairpulling Scale
timeFrame: Once every two weeks for the 10 weeks of the study
Other outcomes:
Locations:
city: Chicago
country: United States
facility: University of Chicago
state: Illinois
Study officials:
affiliation: University of Chicago
name: Jon E Grant, MD,JD,MPH
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.