An Open-Label Study Of Lamictal In Neurotic Excoriation

NCT00269594 | Completed Phase 2

• 1 other identifier: 0510M77009
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Neurotic Disorders; Obsessive-Compulsive Disorder

Keywords

Skin; Picking; Pick; Neurotic Excoriation

Outcome Measures

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

Interventions

Lamictal (lamotrigine) DRUG

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• men and women age 18-65
• current diagnosis of neurotic excoriation

You may not qualify if:

• 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)

Sponsors & Collaborators

• University of Minnesota: lead

Study Sites (1)

University of Minnesota

Minneapolis, Minnesota, 55454, United States

Location

Related Publications (1)

• Grant JE, Odlaug BL, Kim SW. Lamotrigine treatment of pathologic skin picking: an open-label study. J Clin Psychiatry. 2007 Sep;68(9):1384-91. doi: 10.4088/jcp.v68n0909.

  PMID: 17915977 DERIVED

MeSH Terms

Conditions

Neurotic Disorders; Obsessive-Compulsive Disorder

Interventions

Lamotrigine

Condition Hierarchy (Ancestors)

Anxiety Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Triazines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Jon E Grant, JD, MD

  University of Minnesota

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: December 22, 2005
• First Posted: December 23, 2005
• Study Start: January 1, 2006
• Study Completion: September 1, 2006
• Last Updated: April 30, 2007

Record last verified: 2007-04

Locations

US (1)