Inositol in Trichotillomania

• Sponsor: University of Chicago (Other)
• Overall Status: Completed
• CT.gov ID: NCT01875445
• Collaborator: (none)
• Enrollment: 38
• Location: 1
• Arms: 2
• Duration (Months): 36
• Patients Per Site Per Month: 1.1

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Trichotillomania; Hair Pulling	Drug: Inositol; Drug: Placebo	Phase 2

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 Design

• Study Type: Interventional
• Actual Enrollment: 38 participants
• Allocation: Randomized
• Intervention Model: Single Group Assignment
• Masking: Triple (Participant, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: A Double-Blind, Placebo-Controlled Study of Inositol in Trichotillomania
• Study Start Date: May 1, 2013
• Actual Primary Completion Date: May 1, 2016
• Actual Study Completion Date: May 1, 2016

Arms and Interventions

Arm	Intervention/Treatment
Placebo Comparator: Placebo Matched dosage of inositol daily.	Drug: 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
Active Comparator: Inositol Powder form, 2g TID up to 6g TID	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 Powder

Outcome Measures

Primary Outcome Measures

1. The National Institute of Mental Health Trichotillomania Symptom Severity Scale (NIMH-TSS) [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.

Secondary Outcome Measures

1. The Massachusetts General Hospital (MGH) Hairpulling Scale [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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 65 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Chicago	Chicago	Illinois	United States	60637

Sponsors and Collaborators

• University of Chicago

Investigators

• Principal Investigator: Jon E Grant, MD,JD,MPH, University of Chicago

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Jon Grant, Professor, University of Chicago
• ClinicalTrials.gov Identifier: NCT01875445
• Other Study ID Numbers: 2013InositolTTM
• First Posted: Jun 11, 2013
• Last Update Posted: May 19, 2017
• Last Verified: Apr 1, 2017

• Keywords provided by Jon Grant, Professor, University of Chicago: Inositol; Trichotillomania; Hair Pulling; Impulse Control Disorder
• Additional relevant MeSH terms: Trichotillomania; Inositol

Study Results

Participant Flow

Arm/Group Title	Placebo	Inositol
Arm/Group Description	Matched dosage of inositol daily. 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.	Powder form, 2g TID up to 6g TID 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.
Period Title: Overall Study
STARTED	19	19
COMPLETED	12	19
NOT COMPLETED	7	0

Baseline Characteristics

Arm/Group Title	Placebo	Inositol	Total
Arm/Group Description	Matched dosage of inositol daily. 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.	Powder form, 2g TID up to 6g TID 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.	Total of all reporting groups
Overall Participants	19	19	38
Age (Years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [Years]	29.8 (12.2)	28.0 (11.4)	28.9 (11.4)
Sex: Female, Male (Count of Participants)
Female	18 94.7%	17 89.5%	35 92.1%
Male	1 5.3%	2 10.5%	3 7.9%
Race/Ethnicity, Customized (Count of Participants)
White	17 89.5%	18 94.7%	35 92.1%
African American	2 10.5%	0 0%	2 5.3%
Latino/Hispanic	0 0%	1 5.3%	1 2.6%
Region of Enrollment (participants) [Number]
United States	19 100%	19 100%	38 100%
National Institute of Mental Health Trichotillomania Severity Scale (units on a scale) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [units on a scale]	11.6 (3.4)	12.9 (3.7)	12.3 (3.6)
Massachusetts General Hospital Hairpulling Scale (units on a scale) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [units on a scale]	17.9 (3.3)	18.8 (4.2)	18.4 (3.8)
The Clinical Global Impressions Scale-Severity (units on a scale) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [units on a scale]	4.2 (.5)	4.5 (.6)	4.4 (.6)

Outcome Measures

1. Primary Outcome

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

Outcome Measure Data

Analysis Population Description

Last observation carried forward for general means.

Arm/Group Title	Placebo	Inositol
Arm/Group Description	Matched dosage of inositol daily. 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.	Powder form, 2g TID up to 6g TID 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.
Measure Participants	19	19
Mean (Standard Deviation) [units on a scale]	8.4 (5.5)	8.4 (5.1)

2. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

Last observation carried forwards for general averages.

Arm/Group Title	Placebo	Inositol
Arm/Group Description	Matched dosage of inositol daily. 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.	Powder form, 2g TID up to 6g TID 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.
Measure Participants	19	19
Mean (Standard Deviation) [units on a scale]	14.5 (5.1)	13.2 (6.8)

Adverse Events

Arm/Group Title	Placebo		Inositol
Arm/Group Description	Matched dosage of inositol daily. 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.		Powder form, 2g TID up to 6g TID 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.
All Cause Mortality
	Placebo		Inositol
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/19 (0%)		0/19 (0%)
Serious Adverse Events
	Placebo		Inositol
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/19 (0%)		1/19 (5.3%)
Pregnancy, puerperium and perinatal conditions
Ectopic Pregnancy	0/19 (0%)	0	1/19 (5.3%)	1
Other (Not Including Serious) Adverse Events
	Placebo		Inositol
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	4/19 (21.1%)		9/19 (47.4%)
Gastrointestinal disorders
Nausea/Upset Stomach	2/19 (10.5%)	3	4/19 (21.1%)	6
Stomach Pain	0/19 (0%)	0	2/19 (10.5%)	2
Diarrhea	0/19 (0%)	0	2/19 (10.5%)	2
Gas	0/19 (0%)	0	1/19 (5.3%)	1
General disorders
Headache	2/19 (10.5%)	2	2/19 (10.5%)	2

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.