An Open-Label Study Of Lamictal In Neurotic Excoriation

This study has been completed.
Sponsor:
Information provided by:
University of Minnesota - Clinical and Translational Science Institute
ClinicalTrials.gov Identifier:
NCT00269594
First received: December 22, 2005
Last updated: April 27, 2007
Last verified: April 2007

December 22, 2005
April 27, 2007
January 2006
Not Provided
Yale-Brown Obsessive Compulsive Scale Modified for Neurotic Excoriation
Same as current
Complete list of historical versions of study NCT00269594 on ClinicalTrials.gov Archive Site
Skin Picking Symptom Assessment Scale (SP-SAS) and the Clinical Global Impression scale
Same as current
Not Provided
Not Provided
 
An Open-Label Study Of Lamictal In Neurotic Excoriation
An Open-Label Study of Lamictal In Neurotic Excoriation

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.

Not Provided
Interventional
Phase 2
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Neurotic Disorders
  • Obsessive-Compulsive Disorder
Drug: Lamictal (lamotrigine)
Not Provided
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
25
September 2006
Not Provided

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)
Both
18 Years to 65 Years
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00269594
0510M77009
Not Provided
Not Provided
University of Minnesota - Clinical and Translational Science Institute
Not Provided
Principal Investigator: Jon E Grant, JD, MD University of Minnesota - Clinical and Translational Science Institute
University of Minnesota - Clinical and Translational Science Institute
April 2007

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP