- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01875445
Inositol in Trichotillomania
A Double-Blind, Placebo-Controlled Study of Inositol in Trichotillomania
Study Overview
Status
Conditions
Intervention / 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
Enrollment (Actual)
Phase
- Phase 2
Contacts and Locations
Study Locations
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Illinois
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Chicago, Illinois, United States, 60637
- University of Chicago
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Age 18-65 years
- Trichotillomania (TTM) as the primary psychiatric diagnosis
- Women's participation required negative results on a beta-human chorionic gonadotropin pregnancy test and stable use of a medically accepted form of contraception.
- Signed informed consent before entry into the study.
Exclusion Criteria:
- Unstable medical illness or clinically significant abnormalities on laboratory tests or physical examination at screening visit
- Current pregnancy or lactation, or inadequate contraception in women of childbearing potential
- A need for medication other than ecopipam with possible psychotropic effects
- Lifetime history of bipolar disorder type I or II, dementia, or schizophrenia as determined by the Structured Clinical Interview for DSM-IV
- Current (past 12-months) DSM-IV substance abuse or dependence
- Positive urine drug screen at screening
- Initiation of cognitive behavior therapy within 3 months prior to study baseline
- Baseline score of ≥17 on the Hamilton Depression Rating Scale (17-item HDRS
- Any suicidality based on clinical interview
- History of head injury or neurological disorder (such as seizures)
- Any history of psychiatric hospitalization in the past year
- Any history of a suicide attempt
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Single Group Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Placebo Comparator: Placebo
Matched dosage of inositol daily.
|
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:
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Active Comparator: Inositol
Powder form, 2g TID up to 6g TID
|
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:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
The National Institute of Mental Health Trichotillomania Symptom Severity Scale (NIMH-TSS)
Time Frame: 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.
|
Once every two weeks for the 10 weeks of the study
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
The Massachusetts General Hospital (MGH) Hairpulling Scale
Time Frame: 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.
|
Once every two weeks for the 10 weeks of the study
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Jon E Grant, MD,JD,MPH, University of Chicago
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2013InositolTTM
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Trichotillomania
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Yale UniversityNeurocrine BiosciencesRecruitingTrichotillomania (Hair-Pulling Disorder)United States
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Johns Hopkins UniversityRecruitingTrichotillomania | Trichotillomania (Hair-Pulling Disorder) | Hair PullingUnited States
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University of ChicagoNot yet recruitingTrichotillomania (Hair-Pulling Disorder) | DermatillomaniaUnited States
-
University of ChicagoCompletedTrichotillomania (Hair-Pulling Disorder) | DermatillomaniaUnited States
-
University of ChicagoRecruitingTrichotillomania (Hair-Pulling Disorder) | Skin-PickingUnited States
-
American UniversityCompletedTrichotillomania (Hair-Pulling Disorder) | Skin-PickingUnited States
-
HabitAware Inc.National Institute of Mental Health (NIMH); Marquette UniversityCompletedTrichotillomaniaUnited States
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University of Wisconsin, MilwaukeeCompleted
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University of PennsylvaniaNational Institute of Mental Health (NIMH)CompletedTrichotillomaniaUnited States
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University of Sao PauloCompleted
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