Double-Blind Lamictal (Lamotrigine) in Neurotic Excoriation

NCT00513019 | Completed Phase 2 Results DMC

• 1 other identifier: 0703M03384
• Study Type: interventional
• Target: 35
• Locations: 1 country
• Sites: 1

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.

Conditions

Neurotic Excoriation; Pathologic Skin Picking; Psychogenic Excoriation; Dermatillomania

Keywords

Neurotic Excoriation; Pathologic Skin Picking; Psychogenic Excoriation

Outcome Measures

Primary Outcomes (1)

• 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.

Study Arms (2)

1

ACTIVE COMPARATOR

Lamictal (lamotrigine)

Drug: Lamictal (lamotrigine)

2

PLACEBO COMPARATOR

Placebo

Drug: Placebo

Interventions

Lamictal (lamotrigine) DRUG

once daily from beginning to end of study. Dosage varies.

Also known as: lamotrigine

1

Placebo DRUG

daily

2

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• 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 (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.

Sponsors & Collaborators

• University of Chicago: lead

Study Sites (1)

Ambulatory Research Center

Minneapolis, Minnesota, 55454, United States

Location

MeSH Terms

Conditions

Excoriation Disorder

Interventions

Lamotrigine

Condition Hierarchy (Ancestors)

Self-Injurious Behavior; Behavioral Symptoms; Behavior; Obsessive-Compulsive Disorder; Anxiety Disorders; Mental Disorders; Disruptive, Impulse Control, and Conduct Disorders

Intervention Hierarchy (Ancestors)

Triazines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Results Point of Contact

• Title: Jon E. Grant
• Organization: University of Minnesota

grant045@umn.edu

612-273-9800

Study Officials

• Jon E Grant, M.D.

  University of Minnesota

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 7, 2007
• First Posted: August 8, 2007
• Study Start: August 1, 2007
• Primary Completion: August 1, 2009
• Study Completion: September 1, 2009
• Last Updated: February 23, 2023
• Results First Posted: September 27, 2013

Record last verified: 2023-02

Locations

US (1)