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| Sponsor: | University of Minnesota - Clinical and Translational Science Institute |
|---|---|
| Information provided by: | 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 |
Drug: Lamictal (lamotrigine) Drug: Placebo |
Phase II |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Single Group Assignment, Efficacy Study |
| Official Title: | A Double-Blind Study of Lamictal in Neurotic Excoriation |
| Estimated Enrollment: | 30 |
| Study Start Date: | August 2007 |
| Estimated Study Completion Date: | September 2009 |
| Estimated Primary Completion Date: | September 2009 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
1: Active Comparator
Lamictal (lamotrigine)
|
Drug: Lamictal (lamotrigine)
once daily from beginning to end of study. Dosage varies.
|
|
2: Placebo Comparator
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: | University of Minnesota ( Jon E. Grant ) |
| Study ID Numbers: | 0703M03384 |
| Study First Received: | August 7, 2007 |
| Last Updated: | August 12, 2009 |
| ClinicalTrials.gov Identifier: | NCT00513019 History of Changes |
| Health Authority: | United States: Institutional Review Board |
|
Neurotic Excoriation Pathologic Skin Picking Psychogenic Excoriation |
|
Skin Diseases Molecular Mechanisms of Pharmacological Action Calcium Channel Blockers Cardiovascular Agents Pharmacologic Actions Behavioral Symptoms Membrane Transport Modulators |
Therapeutic Uses Lamotrigine Central Nervous System Agents Anticonvulsants Dermatitis Self-Injurious Behavior |