An Open-Label Study Of Lamictal In Neurotic Excoriation

Phase 2

Completed

• Conditions: Neurotic Disorders; Obsessive-Compulsive Disorder

• Registration Number: NCT00269594
• Lead Sponsor: University of Minnesota

Brief Summary

The goal of the proposed study is to evaluate the efficacy and safety of Lamictal in neurotic excoriation. Twenty subjects with neurotic excoriation will receive 12 weeks of open-label treatment with Lamictal. The hypothesis to be tested is that Lamictal will be effective and well tolerated 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

Not available

Study Timeline

• Study First Submitted: 2005-12-22
• Study First Submitted QC: 2005-12-22
• Study First Posted: 2005-12-23
• Study Start: 2006-01
• Study Completion: 2006-09
• Status Verified: 2007-04
• Last Update Submitted: 2007-04-27
• Last Update Posted: 2007-04-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 25

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
• 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 and
• patients who have previously been diagnosed with a medical condition that cause skin itchiness (e.g. liver, kidney, and blood diseases, etopic allergies)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Yale-Brown Obsessive Compulsive Scale Modified for Neurotic Excoriation

Secondary Outcome Measures

Name	Time	Method
Skin Picking Symptom Assessment Scale (SP-SAS) and the Clinical Global Impression scale

Trial Locations

Locations (1)

University of Minnesota; 🇺🇸 Minneapolis, Minnesota, United States