Double-Blind Lamictal (Lamotrigine) in Neurotic Excoriation

The University of Chicago

Status and phase: Completed; Phase 2

Conditions: Pathologic Skin Picking; Dermatillomania; Neurotic Excoriation; Psychogenic Excoriation

Treatments: Drug: Placebo; Drug: Lamictal (lamotrigine)

Study type: Interventional

Funder types: Other

Identifiers

NCT00513019

0703M03384

Details and patient eligibility

About

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.

Full 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.

Enrollment: 35 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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35 participants in 2 patient groups, including a placebo group

1

Active Comparator group

Description:

Lamictal (lamotrigine)

Treatment:

Drug: Lamictal (lamotrigine)

2

Placebo Comparator group

Description:

Placebo

Treatment:

Drug: Placebo