An Open-Label Study Of Lamictal In Neurotic Excoriation
Information source: University of Minnesota
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Neurotic Disorders; Obsessive-Compulsive Disorder
Intervention: Lamictal (lamotrigine) (Drug)
Phase: Phase 2
Status: Completed
Sponsored by: University of Minnesota Official(s) and/or principal investigator(s):
Jon E Grant, JD, MD, Principal Investigator, Affiliation: University of Minnesota
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.
Clinical Details
Official title: An Open-Label Study of Lamictal In Neurotic Excoriation
Study design: Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
Primary outcome: Yale-Brown Obsessive Compulsive Scale Modified for Neurotic Excoriation
Secondary outcome: Skin Picking Symptom Assessment Scale (SP-SAS) and the Clinical Global Impression scale
Eligibility
Minimum age: 18 Years.
Maximum age: 65 Years.
Gender(s): Both.
Criteria:
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)
Locations and Contacts
University of Minnesota, Minneapolis, Minnesota 55454, United States
Additional Information
Starting date: January 2006
Ending date: September 2006
Last updated: April 27, 2007
|
