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| Sponsor: | University of Minnesota - Clinical and Translational Science Institute |
|---|---|
| Information provided by (Responsible Party): | Jon E. Grant, University of Minnesota - Clinical and Translational Science Institute |
| ClinicalTrials.gov Identifier: | NCT00513019 |
Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Neurotic Excoriation Pathologic Skin Picking Psychogenic Excoriation Dermatillomania |
Drug: Lamictal (lamotrigine) Drug: Placebo |
Phase II |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Single Group Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Treatment |
| Official Title: | A Double-Blind Study of Lamictal in Neurotic Excoriation |
| Enrollment: | 35 |
| Study Start Date: | August 2007 |
| Study Completion Date: | September 2009 |
| Primary Completion Date: | August 2009 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Active Comparator: 1
Lamictal (lamotrigine)
|
Drug: Lamictal (lamotrigine)
once daily from beginning to end of study. Dosage varies.
Other Name: lamotrigine
|
|
Placebo Comparator: 2
Placebo
|
Drug: Placebo
daily
|
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.
Eligibility| Ages Eligible for Study: | 18 Years to 65 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| United States, Minnesota | |
| Ambulatory Research Center | |
| Minneapolis, Minnesota, United States, 55454 | |
| Principal Investigator: | Jon E Grant, M.D. | University of Minnesota - Clinical and Translational Science Institute |
More Information
| Responsible Party: | Jon E. Grant, Professor of Psychiatry, University of Minnesota - Clinical and Translational Science Institute |
| ClinicalTrials.gov Identifier: | NCT00513019 History of Changes |
| Other Study ID Numbers: | 0703M03384 |
| Study First Received: | August 7, 2007 |
| Last Updated: | February 1, 2012 |
| Health Authority: | United States: Institutional Review Board |
|
Neurotic Excoriation Pathologic Skin Picking Psychogenic Excoriation |
|
Dermatitis Self-Injurious Behavior Skin Diseases Behavioral Symptoms Lamotrigine Calcium Channel Blockers Membrane Transport Modulators |
Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Cardiovascular Agents Therapeutic Uses Anticonvulsants Central Nervous System Agents |