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NCT Number: NCT00513019

Double-Blind Lamictal (Lamotrigine) 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.

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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Ambulatory Research Center

Minneapolis, Minnesota, 55454, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

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 (lamotrigine);
  • 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.

Treatment and study plan

Lamictal (lamotrigine)

Drug

once daily from beginning to end of study. Dosage varies.

Other names: lamotrigine

Placebo

Drug

daily

Primary outcomes

  1. 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 their participation in the study (12-weeks); investigator rated. Note: Reported mean and standard deviation is the final reported data point.

    The Yale-Brown Obsessive Compulsive Scale Modified for Neurotic Excoriation (NE-YBOCS) was the primary outcome measure - severity of illness. The NE-YBOCS is a reliable and valid, 10-item, clinician-administered scale that rates buying symptoms within the last seven days, on a severity scale from 0 to 4 for each item (total scores range from 0 to 40 with higher scores reflecting greater illness severity).

Sponsors and collaborators

Lead sponsor

University of Chicago

Other

Registry information

Official study title

A Double-Blind Study of Lamictal in Neurotic Excoriation

Important dates

Study start
2007
Primary completion
2009
Study completion
2009
First posted
Aug 8, 2007
Registry last updated
Feb 23, 2023

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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