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Double-Blind Lamictal (Lamotrigine) in Neurotic Excoriation
This study is ongoing, but not recruiting participants.
Study NCT00513019   Information provided by University of Minnesota
First Received: August 7, 2007   Last Updated: August 12, 2009   History of Changes

August 7, 2007
August 12, 2009
August 2007
September 2009   (final data collection date for primary outcome measure)
The Yale-Brown Obsessive Compulsive Scale Modified for Neurotic Excoriation (NE-YBOCS) will be the primary outcome measure [ Time Frame: beginning and at each visit until the end of study ] [ Designated as safety issue: No ]
The Yale-Brown Obsessive Compulsive Scale Modified for Neurotic Excoriation (NE-YBOCS) will be the primary outcome measure
Complete list of historical versions of study NCT00513019 on ClinicalTrials.gov Archive Site
 
 
 
Double-Blind Lamictal (Lamotrigine) in Neurotic Excoriation
A Double-Blind Study of Lamictal in Neurotic Excoriation

The goal of the proposed study is to evaluate the comparative efficacy of Lamictal (lamotrigine) to placebo in neurotic excoriation. Thirty subjects with neurotic excoriation will receive 12 weeks of double-blind treatment with Lamictal (lamotrigine) or matching placebo. The hypothesis to be tested is that Lamictal (lamotrigine) will be more effective than placebo 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.

The study will consist of 12 weeks of double-blind treatment with Lamictal (lamotrigine) compared to placebo (1:1) in 30 subjects with neurotic excoriation.

Phase II
Interventional
Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Single Group Assignment, Efficacy Study
  • Neurotic Excoriation
  • Pathologic Skin Picking
  • Psychogenic Excoriation
  • Drug: Lamictal (lamotrigine)
  • Drug: Placebo
  • Active Comparator: Lamictal (lamotrigine)
  • Placebo Comparator: Placebo
 

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Active, not recruiting
30
September 2009
September 2009   (final data collection date for primary outcome measure)

Inclusion Criteria:

  1. men and women age 18-65;
  2. current diagnosis of neurotic excoriation.

Exclusion Criteria:

  1. unstable medical illness or clinically significant abnormalities on prestudy laboratory tests or physical examination;
  2. history of seizures;
  3. myocardial infarction within 6 months;
  4. current pregnancy or lactation, or inadequate contraception in women of childbearing potential;
  5. a need for medication other than Lamictal with possible psychotropic effects or unfavorable interactions with Lamictal;
  6. clinically significant suicidality;
  7. lifetime history of DSM-IV bipolar disorder type I, dementia, or schizophrenia or any other DSM-IV psychotic disorder;
  8. current or recent (past 3 months) DSM-IV substance abuse or dependence;
  9. illegal substance use within 2 weeks of study initiation;
  10. initiation of psychotherapy or behavior therapy from a mental health professional within 3 months prior to study baseline;
  11. previous treatment with Lamictal (lamotrigine);
  12. 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;
  13. current treatment with an anti-epileptic medication.
Both
18 Years to 65 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00513019
Jon E. Grant, University of Minnesota
0703M03384
University of Minnesota
 
Principal Investigator: Jon E Grant, M.D. University of Minnesota
University of Minnesota
August 2009

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