Double-Blind Lamictal (Lamotrigine) in Neurotic Excoriation

NCT ID: NCT00513019

Last Updated: 2023-02-23

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 35 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-08-31
• Study Completion Date: 2009-09-30

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.

Conditions

Neurotic Excoriation; Pathologic Skin Picking; Psychogenic Excoriation; Dermatillomania

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

1

Lamictal (lamotrigine)

Group Type: ACTIVE_COMPARATOR

Lamictal (lamotrigine)

Intervention Type: DRUG

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

2

Placebo

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

daily

Interventions

Lamictal (lamotrigine)

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

Intervention Type: DRUG

Placebo

daily

Intervention Type: DRUG

Other Intervention Names

lamotrigine

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Chicago

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jon E Grant, M.D.

Role: PRINCIPAL_INVESTIGATOR

University of Minnesota

Locations

Ambulatory Research Center

Minneapolis, Minnesota, United States

Countries

United States

Other Identifiers

0703M03384

Identifier Type: -

Identifier Source: org_study_id