Back to resultsDouble-Blind Lamictal (Lamotrigine) in Neurotic Excoriation
Primary Purpose
Neurotic Excoriation, Pathologic Skin Picking, Psychogenic Excoriation
Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Lamictal (lamotrigine)
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Neurotic Excoriation focused on measuring Neurotic Excoriation, Pathologic Skin Picking, Psychogenic Excoriation
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 (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.
Sites / Locations
- Ambulatory Research Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
1
2
Arm Description
Lamictal (lamotrigine)
Placebo
Outcomes
Primary Outcome Measures
The Yale-Brown Obsessive Compulsive Scale Modified for Neurotic Excoriation (NE-YBOCS) Will be the Primary Outcome Measure
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).
Secondary Outcome Measures
Full Information
NCT ID
NCT00513019
First Posted
August 7, 2007
Last Updated
February 21, 2023
Sponsor
University of Chicago
1. Study Identification
Unique Protocol Identification Number
NCT00513019
Brief Title
Double-Blind Lamictal (Lamotrigine) in Neurotic Excoriation
Official Title
A Double-Blind Study of Lamictal in Neurotic Excoriation
Study Type
Interventional
2. Study Status
Record Verification Date
February 2023
Overall Recruitment Status
Completed
Study Start Date
August 2007 (undefined)
Primary Completion Date
August 2009 (Actual)
Study Completion Date
September 2009 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Chicago
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
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.
Detailed Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Neurotic Excoriation, Pathologic Skin Picking, Psychogenic Excoriation, Dermatillomania
Keywords
Neurotic Excoriation, Pathologic Skin Picking, Psychogenic Excoriation
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
35 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Active Comparator
Arm Description
Lamictal (lamotrigine)
Arm Title
2
Arm Type
Placebo Comparator
Arm Description
Placebo
Intervention Type
Drug
Intervention Name(s)
Lamictal (lamotrigine)
Other Intervention Name(s)
lamotrigine
Intervention Description
once daily from beginning to end of study. Dosage varies.
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
daily
Primary Outcome Measure Information:
Title
The Yale-Brown Obsessive Compulsive Scale Modified for Neurotic Excoriation (NE-YBOCS) Will be the Primary Outcome Measure
Description
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).
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.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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 (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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jon E Grant, M.D.
Organizational Affiliation
University of Minnesota
Official's Role
Principal Investigator
Facility Information:
Facility Name
Ambulatory Research Center
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55454
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Double-Blind Lamictal (Lamotrigine) in Neurotic Excoriation
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