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An Open-Label Study Of Lamictal In Neurotic Excoriation

Primary Purpose

Neurotic Disorders, Obsessive-Compulsive Disorder

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Lamictal (lamotrigine)
Sponsored by
University of Minnesota
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Neurotic Disorders focused on measuring Skin, Picking, Pick, Neurotic Excoriation

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesAccepts 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)

Sites / Locations

  • University of Minnesota

Outcomes

Primary Outcome Measures

Yale-Brown Obsessive Compulsive Scale Modified for Neurotic Excoriation

Secondary Outcome Measures

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

Full Information

First Posted
December 22, 2005
Last Updated
April 27, 2007
Sponsor
University of Minnesota
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1. Study Identification

Unique Protocol Identification Number
NCT00269594
Brief Title
An Open-Label Study Of Lamictal In Neurotic Excoriation
Official Title
An Open-Label Study of Lamictal In Neurotic Excoriation
Study Type
Interventional

2. Study Status

Record Verification Date
April 2007
Overall Recruitment Status
Completed
Study Start Date
January 2006 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
September 2006 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
University of Minnesota

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Neurotic Disorders, Obsessive-Compulsive Disorder
Keywords
Skin, Picking, Pick, Neurotic Excoriation

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
25 (Actual)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Lamictal (lamotrigine)
Primary Outcome Measure Information:
Title
Yale-Brown Obsessive Compulsive Scale Modified for Neurotic Excoriation
Secondary Outcome Measure Information:
Title
Skin Picking Symptom Assessment Scale (SP-SAS) and the Clinical Global Impression scale

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jon E Grant, JD, MD
Organizational Affiliation
University of Minnesota
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Minnesota
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55454
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
17915977
Citation
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.
Results Reference
derived

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An Open-Label Study Of Lamictal In Neurotic Excoriation

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