Double-Blind Lamictal (Lamotrigine) in Neurotic Excoriation

Dermatillomania Clinical Trial

Official title:

A Double-Blind Study of Lamictal in Neurotic Excoriation

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00513019
• Other study ID #: 0703M03384
• Status: Completed
• Phase: Phase 2
• Start date: August 2007
• Est. completion date: September 2009

Study information

• Verified date: February 2023
• Source: University of Chicago
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 35
• Est. completion date: September 2009
• Est. primary completion date: August 2009
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Dermatillomania
• Dermatitis
• Neurotic Excoriation
• Pathologic Skin Picking
• Psychogenic Excoriation
• Self-Injurious Behavior

Intervention

Drug:
• Lamictal (lamotrigine)
once daily from beginning to end of study. Dosage varies.
• Placebo
daily

Locations

Country	Name	City	State
United States	Ambulatory Research Center	Minneapolis	Minnesota

Sponsors (1)

Lead Sponsor	Collaborator
University of Chicago

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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).	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.