Double-Blind Lamictal (Lamotrigine) in Neurotic Excoriation

Condition(s) targeted: Neurotic Excoriation; Pathologic Skin Picking; Psychogenic Excoriation

Intervention: Lamictal (lamotrigine) (Drug); Placebo (Drug)

Phase: Phase 2

Status: Recruiting

Sponsored by: University of Minnesota

Official(s) and/or principal investigator(s):
Jon E Grant, M.D., Principal Investigator, Affiliation: University of Minnesota

Overall contact:
Brian L Odlaug, Phone: 612-627-4363, Email: odla0019@umn.edu

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.

Official title: A Double-Blind Study of Lamictal in Neurotic Excoriation

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

Primary outcome: The Yale-Brown Obsessive Compulsive Scale Modified for Neurotic Excoriation (NE-YBOCS) will be the primary outcome measure

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.

Minimum age: 18 Years. Maximum age: 65 Years. Gender(s): Both.

Criteria:

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.

Brian L Odlaug, Phone: 612-627-4363, Email: odla0019@umn.edu

Ambulatory Research Center, Minneapolis, Minnesota 55454, United States; Recruiting
Brian L Odlaug, B.A., Phone: 612-627-4363, Email: odla0019@umn.edu
Jon E Grant, M.D., Principal Investigator

Starting date: August 2007
Ending date: February 2009
Last updated: September 12, 2008