Double-Blind Lamictal (Lamotrigine) in Neurotic Excoriation
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Neurotic Excoriation Pathologic Skin Picking Psychogenic Excoriation Dermatillomania |
Drug: Lamictal (lamotrigine) Drug: Placebo |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Single Group Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Treatment |
| Official Title: | A Double-Blind Study of Lamictal in Neurotic Excoriation |
- The Yale-Brown Obsessive Compulsive Scale Modified for Neurotic Excoriation (NE-YBOCS) will be the primary outcome measure [ Time Frame: beginning and at each visit until the end of study ] [ Designated as safety issue: No ]
| Enrollment: | 35 |
| Study Start Date: | August 2007 |
| Study Completion Date: | September 2009 |
| Primary Completion Date: | August 2009 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Active Comparator: 1
Lamictal (lamotrigine)
|
Drug: Lamictal (lamotrigine)
once daily from beginning to end of study. Dosage varies.
Other Name: lamotrigine
|
|
Placebo Comparator: 2
Placebo
|
Drug: Placebo
daily
|
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.
Eligibility| Ages Eligible for Study: | 18 Years to 65 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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.
Contacts and Locations| United States, Minnesota | |
| Ambulatory Research Center | |
| Minneapolis, Minnesota, United States, 55454 | |
| Principal Investigator: | Jon E Grant, M.D. | University of Minnesota - Clinical and Translational Science Institute |
More Information
No publications provided
| Responsible Party: | Jon E. Grant, Professor of Psychiatry, University of Minnesota - Clinical and Translational Science Institute |
| ClinicalTrials.gov Identifier: | NCT00513019 History of Changes |
| Other Study ID Numbers: | 0703M03384 |
| Study First Received: | August 7, 2007 |
| Last Updated: | February 1, 2012 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by University of Minnesota - Clinical and Translational Science Institute:
|
Neurotic Excoriation Pathologic Skin Picking Psychogenic Excoriation |
Additional relevant MeSH terms:
|
Dermatitis Self-Injurious Behavior Skin Diseases Behavioral Symptoms Lamotrigine Calcium Channel Blockers Membrane Transport Modulators |
Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Cardiovascular Agents Therapeutic Uses Anticonvulsants Central Nervous System Agents |
ClinicalTrials.gov processed this record on May 19, 2013