A Double-Blind, Placebo-Controlled Study of Inositol in Trichotillomania
18 Years
65 Years
Both
Trichotillomania, Hair Pulling
Trial Information
A Double-Blind, Placebo-Controlled Study of Inositol in Trichotillomania
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.
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
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Outcome Measure:
The NIMH Trichotillomania Scales Trichotillomania Symptom Severity Scale (NIMH-TSS)
Outcome Description:
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. At each of these visits the outcome will be assessed. The scale itself asses severity of hair pulling.
Outcome Time Frame:
Once every two weeks for the 10 weeks of the study
Safety Issue:
No
Principal Investigator
Jon E Grant, MD,JD,MPH
Investigator Role:
Principal Investigator
Investigator Affiliation:
University of Chicago
Authority:
United States: Food and Drug Administration
Study ID:
2013InositolTTM
NCT ID:
NCT01875445
Start Date:
May 2013
Completion Date:
Related Keywords:
- Trichotillomania
- Hair Pulling
- Inositol
- Trichotillomania
- Hair Pulling
- Impulse Control Disorder
- Trichotillomania
Name | Location |
|---|---|
| University of Chicago | Chicago, Illinois 60637 |
