Trichotillomania, Hair Pulling
Conditions
Keywords
Inositol, Trichotillomania, Hair Pulling, Impulse Control Disorder
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.
Interventions
DRUGInositol
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.
DRUGPlacebo
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.
Sponsors
University of Chicago
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Placebo 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. | 19 |
| Inositol 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. | 19 |
| Total | 38 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost to Follow-up | 5 | 0 |
| Overall Study | Withdrawal by Subject | 2 | 0 |
Baseline characteristics
| Characteristic | Placebo | Inositol | Total |
|---|---|---|---|
| Age, Continuous | 29.8 Years STANDARD_DEVIATION 12.2 | 28.0 Years STANDARD_DEVIATION 11.4 | 28.9 Years STANDARD_DEVIATION 11.4 |
| Massachusetts General Hospital Hairpulling Scale | 17.9 units on a scale STANDARD_DEVIATION 3.3 | 18.8 units on a scale STANDARD_DEVIATION 4.2 | 18.4 units on a scale STANDARD_DEVIATION 3.8 |
| National Institute of Mental Health Trichotillomania Severity Scale | 11.6 units on a scale STANDARD_DEVIATION 3.4 | 12.9 units on a scale STANDARD_DEVIATION 3.7 | 12.3 units on a scale STANDARD_DEVIATION 3.6 |
| Race/Ethnicity, Customized Race/Ethnicity African American | 2 Participants | 0 Participants | 2 Participants |
| Race/Ethnicity, Customized Race/Ethnicity Latino/Hispanic | 0 Participants | 1 Participants | 1 Participants |
| Race/Ethnicity, Customized Race/Ethnicity White | 17 Participants | 18 Participants | 35 Participants |
| Region of Enrollment United States | 19 participants | 19 participants | 38 participants |
| Sex: Female, Male Female | 18 Participants | 17 Participants | 35 Participants |
| Sex: Female, Male Male | 1 Participants | 2 Participants | 3 Participants |
| The Clinical Global Impressions Scale-Severity | 4.2 units on a scale STANDARD_DEVIATION 0.5 | 4.5 units on a scale STANDARD_DEVIATION 0.6 | 4.4 units on a scale STANDARD_DEVIATION 0.6 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 19 | 0 / 19 |
| other Total, other adverse events | 4 / 19 | 9 / 19 |
| serious Total, serious adverse events | 0 / 19 | 1 / 19 |
Outcome results
Primary
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.
Time frame: Once every two weeks for the 10 weeks of the study
Population: Last observation carried forward for general means.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | The National Institute of Mental Health Trichotillomania Symptom Severity Scale (NIMH-TSS) | 8.4 units on a scale | Standard Deviation 5.5 |
| Inositol | The National Institute of Mental Health Trichotillomania Symptom Severity Scale (NIMH-TSS) | 8.4 units on a scale | Standard Deviation 5.1 |
Secondary
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.
Time frame: Once every two weeks for the 10 weeks of the study
Population: Last observation carried forwards for general averages.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | The Massachusetts General Hospital (MGH) Hairpulling Scale | 14.5 units on a scale | Standard Deviation 5.1 |
| Inositol | The Massachusetts General Hospital (MGH) Hairpulling Scale | 13.2 units on a scale | Standard Deviation 6.8 |