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. Identifier: NCT00269594
Recruitment Status : Completed
First Posted : December 23, 2005
Last Update Posted : April 30, 2007
Information provided by:
University of Minnesota - Clinical and Translational Science Institute

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.

Condition or disease Intervention/treatment Phase
Neurotic Disorders Obsessive-Compulsive Disorder Drug: Lamictal (lamotrigine) Phase 2

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 25 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: An Open-Label Study of Lamictal In Neurotic Excoriation
Study Start Date : January 2006
Actual Study Completion Date : September 2006

Resource links provided by the National Library of Medicine

Drug Information available for: Lamotrigine

Primary Outcome Measures :
  1. Yale-Brown Obsessive Compulsive Scale Modified for Neurotic Excoriation

Secondary Outcome Measures :
  1. Skin Picking Symptom Assessment Scale (SP-SAS) and the Clinical Global Impression scale

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00269594

United States, Minnesota
University of Minnesota
Minneapolis, Minnesota, United States, 55454
Sponsors and Collaborators
University of Minnesota - Clinical and Translational Science Institute
Principal Investigator: Jon E Grant, JD, MD University of Minnesota - Clinical and Translational Science Institute

Publications automatically indexed to this study by Identifier (NCT Number): Identifier: NCT00269594     History of Changes
Other Study ID Numbers: 0510M77009
First Posted: December 23, 2005    Key Record Dates
Last Update Posted: April 30, 2007
Last Verified: April 2007

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

Additional relevant MeSH terms:
Compulsive Personality Disorder
Obsessive-Compulsive Disorder
Self-Injurious Behavior
Neurotic Disorders
Pathologic Processes
Personality Disorders
Mental Disorders
Anxiety Disorders
Skin Diseases
Behavioral Symptoms
Calcium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Excitatory Amino Acid Antagonists
Excitatory Amino Acid Agents
Neurotransmitter Agents
Physiological Effects of Drugs
Voltage-Gated Sodium Channel Blockers
Sodium Channel Blockers