An Open-Label Study Of Lamictal In Neurotic Excoriation

This study has been completed.

First Received on December 22, 2005. Last Updated on April 27, 2007 History of Changes

Sponsor:	University of Minnesota - Clinical and Translational Science Institute
Information provided by:	University of Minnesota - Clinical and Translational Science Institute
ClinicalTrials.gov Identifier:	NCT00269594

Purpose

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.

Condition	Intervention	Phase
Neurotic Disorders Obsessive-Compulsive Disorder	Drug: Lamictal (lamotrigine)	Phase II

Study Type:	Interventional
Study Design:	Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	An Open-Label Study of Lamictal In Neurotic Excoriation

Resource links provided by NLM:

MedlinePlus related topics: Obsessive-Compulsive Disorder

Drug Information available for: Lamotrigine

U.S. FDA Resources

Further study details as provided by University of Minnesota - Clinical and Translational Science Institute:

Primary Outcome Measures:

Yale-Brown Obsessive Compulsive Scale Modified for Neurotic Excoriation

Secondary Outcome Measures:

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

Enrollment:	25
Study Start Date:	January 2006
Study Completion Date:	September 2006

Eligibility

Ages Eligible for Study:	18 Years to 65 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

Criteria

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)

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00269594

Locations

United States, Minnesota
University of Minnesota
Minneapolis, Minnesota, United States, 55454

Sponsors and Collaborators

University of Minnesota - Clinical and Translational Science Institute

Investigators

Principal Investigator:

Jon E Grant, JD, MD

University of Minnesota - Clinical and Translational Science Institute

More Information

No publications provided by University of Minnesota - Clinical and Translational Science Institute

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Grant JE, Odlaug BL, Kim SW. Lamotrigine treatment of pathologic skin picking: an open-label study. J Clin Psychiatry. 2007 Sep;68(9):1384-91.

ClinicalTrials.gov Identifier:	NCT00269594 History of Changes
Other Study ID Numbers:	0510M77009
Study First Received:	December 22, 2005
Last Updated:	April 27, 2007
Health Authority:	United States: Institutional Review Board

Keywords provided by University of Minnesota - Clinical and Translational Science Institute:

Skin
Picking
Pick
Neurotic Excoriation

Additional relevant MeSH terms:

Neurotic Disorders
Obsessive-Compulsive Disorder
Dermatitis
Self-Injurious Behavior
Mental Disorders
Anxiety Disorders
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 February 12, 2012