An Open-Label Study Of Lamictal In Neurotic Excoriation

Obsessive-Compulsive Disorder Clinical Trial

Official title:

An Open-Label Study of Lamictal In Neurotic Excoriation

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00269594
• Other study ID #: 0510M77009
• Status: Completed
• Phase: Phase 2
• First received: December 22, 2005
• Last updated: April 27, 2007
• Start date: January 2006
• Est. completion date: September 2006

Study information

• Verified date: April 2007
• Source: University of Minnesota - Clinical and Translational Science Institute
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 25
• Est. completion date: September 2006
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Compulsive Behavior
• Dermatitis
• Disease
• Neurotic Disorders
• Obsessive-Compulsive Disorder
• Self-Injurious Behavior

Intervention

Drug:
• Lamictal (lamotrigine)

Locations

Country	Name	City	State
United States	University of Minnesota	Minneapolis	Minnesota

Sponsors (1)

Lead Sponsor	Collaborator
University of Minnesota - Clinical and Translational Science Institute

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Yale-Brown Obsessive Compulsive Scale Modified for Neurotic Excoriation
Secondary	Skin Picking Symptom Assessment Scale (SP-SAS) and the Clinical Global Impression scale