Trichotillomania
Conditions
Keywords
Trichotillomania, Hair-pulling
Brief summary
This is a 12-week, double-blind study of N-Acetyl Cysteine in the treatment of trichotillomania
Detailed description
The goal of the proposed study is to evaluate the efficacy and safety of N-Acetyl Cysteine (NAC) in trichotillomania. Forty subjects with DSM-IV trichotillomania will receive 12 weeks of double-blind NAC or placebo. The hypothesis to be tested is that NAC will be effective and well tolerated in patients with trichotillomania compared to placebo. The proposed study will provide needed data on the treatment of a disabling disorder that currently lacks a clearly effective treatment.
Interventions
DRUGPlacebo
daily
DRUGN-Acetyl Cysteine
600mg capsules in varying doses for 12 weeks.
Sponsors
University of Chicago
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* men and women age 18-65; * current DSM-IV trichotillomania
Exclusion criteria
* unstable medical illness; * history of seizures; * myocardial infarction within 6 months; * current pregnancy or lactation, or inadequate contraception in women of childbearing potential; * any thoughts of suicide; * lifetime history of DSM-IV bipolar disorder type I, dementia, or schizophrenia or any other DSM-IV psychotic disorder; * previous treatment with N-Acetyl Cysteine; * treatment with investigational medication or depot neuroleptics within 3 months, with fluoxetine within 6 weeks, or with other psychotropics within 2 weeks prior to study baseline; * 9\) diagnosis of asthma
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Massachusetts General Hospital Hairpulling Scale | Baseline and final visit after 12 weeks | There is no minimum or maximum score to quantify 'good' or 'poor' improvement based on this scale. The total score can range from 0-28 with zero being no problems to 28 being the most severe score one can receive.A total of 6 assessments were made, however only the final score (the score at the final visit after 12 weeks) was reported here to show the final outcome measure that was used in the final report of possible improvement and what was reported for final publication of data. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| N-Acetyl Cysteine N-Acetyl Cysteine (NAC) - 1200mg-2400mg by mouth per day | 25 |
| Placebo Placebo pills | 25 |
| Total | 50 |
Baseline characteristics
| Characteristic | Placebo | N-Acetyl Cysteine | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 25 Participants | 25 Participants | 50 Participants |
| Age, Continuous | 32.7 years STANDARD_DEVIATION 10.5 | 35.8 years STANDARD_DEVIATION 13.6 | 34.5 years STANDARD_DEVIATION 11.5 |
| Region of Enrollment United States | 25 participants | 25 participants | 50 participants |
| Sex: Female, Male Female | 21 Participants | 24 Participants | 45 Participants |
| Sex: Female, Male Male | 4 Participants | 1 Participants | 5 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 25 | 3 / 25 |
| serious Total, serious adverse events | 0 / 25 | 0 / 25 |
Outcome results
Primary
Massachusetts General Hospital Hairpulling Scale
There is no minimum or maximum score to quantify 'good' or 'poor' improvement based on this scale. The total score can range from 0-28 with zero being no problems to 28 being the most severe score one can receive.A total of 6 assessments were made, however only the final score (the score at the final visit after 12 weeks) was reported here to show the final outcome measure that was used in the final report of possible improvement and what was reported for final publication of data.
Time frame: Baseline and final visit after 12 weeks
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| N-Acetyl Cysteine | Massachusetts General Hospital Hairpulling Scale | MGH-HPS Baseline | 17.6 units on a scale | Standard Deviation 4.64 |
| N-Acetyl Cysteine | Massachusetts General Hospital Hairpulling Scale | MGH-HPS Final Visit After 12 Weeks | 10.4 units on a scale | Standard Deviation 5.55 |
| Placebo | Massachusetts General Hospital Hairpulling Scale | MGH-HPS Baseline | 16.7 units on a scale | Standard Deviation 5.28 |
| Placebo | Massachusetts General Hospital Hairpulling Scale | MGH-HPS Final Visit After 12 Weeks | 16.0 units on a scale | Standard Deviation 4.9 |