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An Open-Label Study Of Lamictal In Neurotic Excoriation

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00269594
Recruitment Status : Completed
First Posted : December 23, 2005
Last Update Posted : April 30, 2007
Sponsor:
Information provided by:
University of Minnesota

Tracking Information
First Submitted Date  ICMJE December 22, 2005
First Posted Date  ICMJE December 23, 2005
Last Update Posted Date April 30, 2007
Study Start Date  ICMJE January 2006
Primary Completion Date Not Provided
Current Primary Outcome Measures  ICMJE
 (submitted: December 22, 2005)
Yale-Brown Obsessive Compulsive Scale Modified for Neurotic Excoriation
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: December 22, 2005)
Skin Picking Symptom Assessment Scale (SP-SAS) and the Clinical Global Impression scale
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE An Open-Label Study Of Lamictal In Neurotic Excoriation
Official Title  ICMJE An Open-Label Study of Lamictal In Neurotic Excoriation
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 Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Neurotic Disorders
  • Obsessive-Compulsive Disorder
Intervention  ICMJE Drug: Lamictal (lamotrigine)
Study Arms  ICMJE Not Provided
Publications * 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.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: April 27, 2007)
25
Original Enrollment  ICMJE
 (submitted: December 22, 2005)
20
Actual Study Completion Date  ICMJE September 2006
Primary Completion Date Not Provided
Eligibility Criteria  ICMJE

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)
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00269594
Other Study ID Numbers  ICMJE 0510M77009
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Not Provided
Study Sponsor  ICMJE University of Minnesota
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Jon E Grant, JD, MD University of Minnesota
PRS Account University of Minnesota
Verification Date April 2007

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