An Open-Label Study Of Lamictal In Neurotic Excoriation

University of Minnesota (UMN)

Status and phase

Completed

Phase 2

Conditions

Obsessive-Compulsive Disorder

Neurotic Disorders

Treatments

Drug: Lamictal (lamotrigine)

Study type

Interventional

Funder types

Other

Identifiers

NCT00269594

0510M77009

Details and patient eligibility

About

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.

Enrollment

25 patients

Sex

All

Ages

18 to 65 years old

Volunteers

Accepts Healthy Volunteers

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)