Double-Blind Lamictal (Lamotrigine) in Neurotic Excoriation

Study Overview
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Brief Summary
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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
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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.

Official Title
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A Double-Blind Study of Lamictal in Neurotic Excoriation

Conditions
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Neurotic Excoriation, Pathologic Skin Picking, Psychogenic Excoriation, Dermatillomania

Intervention / Treatment
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* Drug: Lamictal (lamotrigine)
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: men and women age 18-65; current diagnosis of neurotic excoriation. Exclusion Criteria: unstable medical illness or clinically significant abnormalities on prestudy laboratory tests or physical examination; history of seizures; myocardial infarction within 6 months; current pregnancy or lactation, or inadequate contraception in women of childbearing potential; a need for medication other than Lamictal with possible psychotropic effects or unfavorable interactions with Lamictal; clinically significant suicidality; lifetime history of DSM-IV bipolar disorder type I, dementia, or schizophrenia or any other DSM-IV psychotic disorder; current or recent (past 3 months) DSM-IV substance abuse or dependence; illegal substance use within 2 weeks of study initiation; initiation of psychotherapy or behavior therapy from a mental health professional within 3 months prior to study baseline; previous treatment with Lamictal (lamotrigine); 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; current treatment with an anti-epileptic medication.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 1<br>Lamictal (lamotrigine) | Drug: Lamictal (lamotrigine)<br>* once daily from beginning to end of study. Dosage varies.<br>* Other names: lamotrigine;|
| Placebo Comparator: 2<br>Placebo | Drug: Placebo<br>* daily<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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). | 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. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Neurotic Excoriation, Pathologic Skin Picking, Psychogenic Excoriation