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Completed

NCT Number: NCT00269594

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.

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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

University of Minnesota

Minneapolis, Minnesota, 55454, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Lamictal (lamotrigine)

Drug

Primary outcomes

  1. Yale-Brown Obsessive Compulsive Scale Modified for Neurotic Excoriation

Secondary outcomes

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

Sponsors and collaborators

Lead sponsor

University of Minnesota

Other

Registry information

Important dates

Study start
2006
Study completion
2006
First posted
Dec 23, 2005
Registry last updated
Apr 30, 2007

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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