Dermatillomania, Neurotic Excoriation, Pathologic Skin Picking, Psychogenic Excoriation
Conditions
Keywords
Neurotic Excoriation, Pathologic Skin Picking, Psychogenic Excoriation
Brief summary
The goal of the proposed study is to evaluate the comparative efficacy of Lamictal (lamotrigine) to placebo in neurotic excoriation. Thirty subjects with neurotic excoriation will receive 12 weeks of double-blind treatment with Lamictal (lamotrigine) or matching placebo. The hypothesis to be tested is that Lamictal (lamotrigine) will be more effective than placebo in patients with neurotic excoriation. The proposed study will provide needed data on the treatment of a disabling disorder that currently lacks a clearly effective treatment.
Detailed description
The study will consist of 12 weeks of double-blind treatment with Lamictal (lamotrigine) compared to placebo (1:1) in 30 subjects with neurotic excoriation.
Interventions
once daily from beginning to end of study. Dosage varies.
DRUGPlacebo
daily
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
1. men and women age 18-65; 2. current diagnosis of neurotic excoriation.
Exclusion criteria
1. unstable medical illness or clinically significant abnormalities on prestudy laboratory tests or physical examination; 2. history of seizures; 3. myocardial infarction within 6 months; 4. current pregnancy or lactation, or inadequate contraception in women of childbearing potential; 5. a need for medication other than Lamictal with possible psychotropic effects or unfavorable interactions with Lamictal; 6. clinically significant suicidality; 7. lifetime history of DSM-IV bipolar disorder type I, dementia, or schizophrenia or any other DSM-IV psychotic disorder; 8. current or recent (past 3 months) DSM-IV substance abuse or dependence; 9. illegal substance use within 2 weeks of study initiation; 10. initiation of psychotherapy or behavior therapy from a mental health professional within 3 months prior to study baseline; 11. previous treatment with Lamictal (lamotrigine); 12. 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; 13. current treatment with an anti-epileptic medication.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The Yale-Brown Obsessive Compulsive Scale Modified for Neurotic Excoriation (NE-YBOCS) Will be the Primary Outcome Measure | beginning and at each visit until the end of their participation in the study (12-weeks); investigator rated. Note: Reported mean and standard deviation is the final reported data point. | The Yale-Brown Obsessive Compulsive Scale Modified for Neurotic Excoriation (NE-YBOCS) was the primary outcome measure - severity of illness. The NE-YBOCS is a reliable and valid, 10-item, clinician-administered scale that rates buying symptoms within the last seven days, on a severity scale from 0 to 4 for each item (total scores range from 0 to 40 with higher scores reflecting greater illness severity). |
Countries
United States
Participant flow
Recruitment details
August 2007 - July 2009
Participants by arm
| Arm | Count |
|---|---|
| Lamictal The subjects began lamotrigine at 25 mg/d every other day for 1 week. At week 1, the dose was raised to 25 mg/d. At week 2, the dose was raised to 50 mg/d for 2 weeks. Thereafter, all visits were scheduled every 2 weeks at which times the dose could be increased to 100 mg/d, then 200 mg/d, and finally 300 mg/d unless clinical improvement was attained at a lower dose (clinical improvement was assessed by the investigator with respect to skin picking behavior, thoughts, and urges). | 17 |
| Placebo Placebo pills (identical to lamictal pills) were taken by mouth once daily. | 18 |
| Total | 35 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Adverse Event | 1 | 0 |
| Overall Study | Withdrawal by Subject | 4 | 5 |
Baseline characteristics
| Characteristic | Placebo | Lamictal | 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 | 18 Participants | 17 Participants | 35 Participants |
| Age, Continuous | 31.6 years STANDARD_DEVIATION 13.3 | 33.2 years STANDARD_DEVIATION 14.1 | 32.8 years STANDARD_DEVIATION 13.3 |
| Region of Enrollment United States | 18 participants | 17 participants | 35 participants |
| Sex: Female, Male Female | 16 Participants | 16 Participants | 32 Participants |
| Sex: Female, Male Male | 2 Participants | 1 Participants | 3 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 1 / 17 | 0 / 18 |
| serious Total, serious adverse events | 0 / 17 | 0 / 18 |
Outcome results
Primary
The Yale-Brown Obsessive Compulsive Scale Modified for Neurotic Excoriation (NE-YBOCS) Will be the Primary Outcome Measure
The Yale-Brown Obsessive Compulsive Scale Modified for Neurotic Excoriation (NE-YBOCS) was the primary outcome measure - severity of illness. The NE-YBOCS is a reliable and valid, 10-item, clinician-administered scale that rates buying symptoms within the last seven days, on a severity scale from 0 to 4 for each item (total scores range from 0 to 40 with higher scores reflecting greater illness severity).
Time frame: beginning and at each visit until the end of their participation in the study (12-weeks); investigator rated. Note: Reported mean and standard deviation is the final reported data point.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Lamictal | The Yale-Brown Obsessive Compulsive Scale Modified for Neurotic Excoriation (NE-YBOCS) Will be the Primary Outcome Measure | 15.25 units on a scale | Standard Deviation 4.1 |
| Placebo | The Yale-Brown Obsessive Compulsive Scale Modified for Neurotic Excoriation (NE-YBOCS) Will be the Primary Outcome Measure | 16.13 units on a scale | Standard Deviation 3.6 |