Inositol in Trichotillomania
Primary Purpose
Trichotillomania, Hair Pulling
Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Inositol
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Trichotillomania focused on measuring Inositol, Trichotillomania, Hair Pulling, Impulse Control Disorder
Eligibility Criteria
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
Sites / Locations
- University of Chicago
Arms of the Study
Arm 1
Arm 2
Arm Type
Placebo Comparator
Active Comparator
Arm Label
Placebo
Inositol
Arm Description
Matched dosage of inositol daily.
Powder form, 2g TID up to 6g TID
Outcomes
Primary Outcome Measures
The National Institute of Mental Health Trichotillomania Symptom Severity Scale (NIMH-TSS)
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.
Secondary Outcome Measures
The Massachusetts General Hospital (MGH) Hairpulling Scale
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01875445
Brief Title
Inositol in Trichotillomania
Official Title
A Double-Blind, Placebo-Controlled Study of Inositol in Trichotillomania
Study Type
Interventional
2. Study Status
Record Verification Date
February 2023
Overall Recruitment Status
Completed
Study Start Date
May 2013 (undefined)
Primary Completion Date
May 2016 (Actual)
Study Completion Date
May 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Chicago
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Trichotillomania, Hair Pulling
Keywords
Inositol, Trichotillomania, Hair Pulling, Impulse Control Disorder
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
38 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Matched dosage of inositol daily.
Arm Title
Inositol
Arm Type
Active Comparator
Arm Description
Powder form, 2g TID up to 6g TID
Intervention Type
Drug
Intervention Name(s)
Inositol
Other Intervention Name(s)
Inositol Powder
Intervention Description
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
Intervention Name(s)
Placebo
Other Intervention Name(s)
Sugar Pill
Intervention Description
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.
Primary Outcome Measure Information:
Title
The National Institute of Mental Health Trichotillomania Symptom Severity Scale (NIMH-TSS)
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, but only baseline and final values will be used for general final outcome assessment. The scale itself asses severity of hair pulling.
Time Frame
Once every two weeks for the 10 weeks of the study
Secondary Outcome Measure Information:
Title
The Massachusetts General Hospital (MGH) Hairpulling Scale
Description
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.
Time Frame
Once every two weeks for the 10 weeks of the study
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jon E Grant, MD,JD,MPH
Organizational Affiliation
University of Chicago
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Chicago
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60637
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
34582562
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.
Results Reference
derived
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Inositol in Trichotillomania
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