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

The goal of the proposed study is to evaluate the comparative efficacy of Lamictal to placebo in neurotic excoriation. Thirty subjects with neurotic excoriation will receive 12 weeks of double-blind treatment with Lamictal or matching placebo. The hypothesis to be tested is that Lamictal 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.

Study Type: Interventional

Study Design: Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Single Group Assignment, Efficacy Study

Study Primary Completion Date: November 2008

The study will consist of 12 weeks of double-blind treatment with Lamictal compared to placebo (1:1) in 30 subjects with neurotic excoriation.

Intervention(s) in this Clinical Trial

• Drug: Lamictal (lamotrigine)
  • once daily from beginning to end of study. Dosage varies.

Primary Measures

• 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
    Safety Issue?: 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;
• 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.

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: 65 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: University of Minnesota

Overall Clinical Trial Officials and Contacts

Jon E Grant, M.D. Principal Investigator University of Minnesota  

Overall Contact: Brian L Odlaug 612-627-4363 odla0019@umn.edu

Information obtained from ClinicalTrials.gov on August 29, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00513019

Study ID Number: 0703M03384

ClinicalTrials.gov Identifier: NCT00513019

Health Authority: United States: Institutional Review Board