Inositol in Trichotillomania
A Double-Blind, Placebo-Controlled Study of Inositol in Trichotillomania
1 other identifier
interventional
38
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_2
Started May 2013
Typical duration for phase_2
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2013
CompletedFirst Submitted
Initial submission to the registry
June 7, 2013
CompletedFirst Posted
Study publicly available on registry
June 11, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2016
CompletedResults Posted
Study results publicly available
May 19, 2017
CompletedFebruary 23, 2023
February 1, 2023
3 years
June 7, 2013
February 27, 2017
February 21, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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.
Once every two weeks for the 10 weeks of the study
Secondary Outcomes (1)
The Massachusetts General Hospital (MGH) Hairpulling Scale
Once every two weeks for the 10 weeks of the study
Study Arms (2)
Placebo
PLACEBO COMPARATORMatched dosage of inositol daily.
Inositol
ACTIVE COMPARATORPowder form, 2g TID up to 6g TID
Interventions
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.
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.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University of Chicago
Chicago, Illinois, 60637, United States
Related Publications (1)
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.
PMID: 34582562DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Dr. Jon Grant
- Organization
- University of Chicago
Study Officials
- PRINCIPAL INVESTIGATOR
Jon E Grant, MD,JD,MPH
University of Chicago
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 7, 2013
First Posted
June 11, 2013
Study Start
May 1, 2013
Primary Completion
May 1, 2016
Study Completion
May 1, 2016
Last Updated
February 23, 2023
Results First Posted
May 19, 2017
Record last verified: 2023-02