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

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.


Condition Intervention Phase
Neurotic Excoriation
Pathologic Skin Picking
Psychogenic Excoriation
Drug: Lamictal (lamotrigine)
Drug: Placebo
Phase II

Study Type: Interventional
Study Design: Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Single Group Assignment, Efficacy Study
Official Title: A Double-Blind Study of Lamictal in Neurotic Excoriation

Resource links provided by NLM:


Further study details as provided by University of Minnesota:

Primary Outcome Measures:
  • 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 ]

Estimated Enrollment: 30
Study Start Date: August 2007
Estimated Study Completion Date: September 2009
Estimated Primary Completion Date: September 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
1: Active Comparator
Lamictal (lamotrigine)
Drug: Lamictal (lamotrigine)
once daily from beginning to end of study. Dosage varies.
2: Placebo Comparator
Placebo
Drug: Placebo
daily

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00513019

Locations
United States, Minnesota
Ambulatory Research Center
Minneapolis, Minnesota, United States, 55454
Sponsors and Collaborators
University of Minnesota
Investigators
Principal Investigator: Jon E Grant, M.D. University of Minnesota
  More Information

No publications provided

Responsible Party: University of Minnesota ( Jon E. Grant )
Study ID Numbers: 0703M03384
Study First Received: August 7, 2007
Last Updated: August 12, 2009
ClinicalTrials.gov Identifier: NCT00513019     History of Changes
Health Authority: United States: Institutional Review Board

Keywords provided by University of Minnesota:
Neurotic Excoriation
Pathologic Skin Picking
Psychogenic Excoriation

Additional relevant MeSH terms:
Skin Diseases
Molecular Mechanisms of Pharmacological Action
Calcium Channel Blockers
Cardiovascular Agents
Pharmacologic Actions
Behavioral Symptoms
Membrane Transport Modulators
Therapeutic Uses
Lamotrigine
Central Nervous System Agents
Anticonvulsants
Dermatitis
Self-Injurious Behavior

ClinicalTrials.gov processed this record on November 30, 2009