Inositol in Trichotillomania | RxWiki

Inositol in Trichotillomania

Overview[ - collapse ][ - ]

Purpose	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.
Condition	Trichotillomania Hair Pulling
Intervention	Drug: Inositol Drug: Placebo
Phase	Phase 2
Sponsor	University of Chicago
Responsible Party	University of Chicago
ClinicalTrials.gov Identifier	NCT01875445
First Received	June 7, 2013
Last Updated	September 4, 2013
Last verified	June 2013

Tracking Information[ + expand ][ + ]

First Received Date	June 7, 2013
Last Updated Date	September 4, 2013
Start Date	May 2013
Estimated Primary Completion Date	Not Provided
Current Primary Outcome Measures	The NIMH Trichotillomania Scales Trichotillomania Symptom Severity Scale (NIMH-TSS) [Time Frame: Once every two weeks for the 10 weeks of the study] [Designated as safety issue: No]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.
Current Secondary Outcome Measures	The Massachusetts General Hospital (MGH) Hairpulling Scale [Time Frame: Once every two weeks for the 10 weeks of the study] [Designated as safety issue: No]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. At each of these visits the outcome will be assessed. The scale itself asses severity of hair pulling.

Descriptive Information[ + expand ][ + ]

Brief Title	Inositol in Trichotillomania
Official Title	A Double-Blind, Placebo-Controlled Study of Inositol in Trichotillomania
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 Type	Interventional
Study Phase	Phase 2
Study Design	Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Condition	Trichotillomania Hair Pulling
Intervention	Drug: 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. Other Names: Inositol PowderDrug: 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. Other Names: Sugar Pill
Study Arm (s)	Placebo Comparator: Placebo Matched dosage of inositol daily. Active Comparator: Inositol Powder form, 2g TID up to 6g TID

Recruitment Information[ + expand ][ + ]

Recruitment Status	Recruiting
Estimated Enrollment	50
Estimated Completion Date	Not Provided
Estimated Primary Completion Date	May 2015
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
Gender	Both
Ages	18 Years
Accepts Healthy Volunteers	No
Contacts	Contact: Katherine Derbyshire 7737029066 kderbyshire@uchicago.edu
Location Countries	United States

Administrative Information[ + expand ][ + ]

NCT Number	NCT01875445
Other Study ID Numbers	2013InositolTTM
Has Data Monitoring Committee	Yes
Information Provided By	University of Chicago
Study Sponsor	University of Chicago
Collaborators	Not Provided
Investigators	Principal Investigator: Jon E Grant, MD,JD,MPH University of Chicago
Verification Date	June 2013

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