Double-Blind Lamictal (Lamotrigine) in Neurotic Excoriation

Phase 2

Completed

• Conditions: Neurotic Excoriation; Pathologic Skin Picking; Dermatillomania; Psychogenic Excoriation
• Interventions: Drug: Lamictal (lamotrigine); Drug: Placebo

• Registration Number: NCT00513019
• Lead Sponsor: University of Chicago

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.

Study Timeline

• Study Start: 2007-08
• Study First Submitted: 2007-08-07
• Study First Submitted QC: 2007-08-07
• Study First Posted: 2007-08-08
• Primary Completion: 2009-08
• Study Completion: 2009-09
• Results First Submitted: 2012-03-01
• Results First Submitted QC: 2013-08-06
• Results First Posted: 2013-09-27
• Status Verified: 2023-02
• Last Update Submitted: 2023-02-21
• Last Update Posted: 2023-02-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 35

Inclusion Criteria

1. men and women age 18-65;
2. current diagnosis of neurotic excoriation.

Exclusion Criteria

1. unstable medical illness or clinically significant abnormalities on prestudy laboratory tests or physical examination;
2. history of seizures;
3. myocardial infarction within 6 months;
4. current pregnancy or lactation, or inadequate contraception in women of childbearing potential;
5. a need for medication other than Lamictal with possible psychotropic effects or unfavorable interactions with Lamictal;
6. clinically significant suicidality;
7. lifetime history of DSM-IV bipolar disorder type I, dementia, or schizophrenia or any other DSM-IV psychotic disorder;
8. current or recent (past 3 months) DSM-IV substance abuse or dependence;
9. illegal substance use within 2 weeks of study initiation;
10. initiation of psychotherapy or behavior therapy from a mental health professional within 3 months prior to study baseline;
11. previous treatment with Lamictal (lamotrigine);
12. 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;
13. current treatment with an anti-epileptic medication.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	Lamictal (lamotrigine)	Lamictal (lamotrigine)
2	Placebo	Placebo

Primary Outcome Measures

Name	Time	Method
The Yale-Brown Obsessive Compulsive Scale Modified for Neurotic Excoriation (NE-YBOCS) Will be the Primary Outcome Measure	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.	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).

Trial Locations

Locations (1)

Ambulatory Research Center; 🇺🇸 Minneapolis, Minnesota, United States