An Open-Label Study Of Lamictal In Neurotic Excoriation
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| ClinicalTrials.gov Identifier: NCT00269594 |
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Recruitment Status :
Completed
First Posted : December 23, 2005
Last Update Posted : April 30, 2007
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Sponsor:
University of Minnesota - Clinical and Translational Science Institute
Information provided by:
University of Minnesota - Clinical and Translational Science Institute
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Brief Summary:
The goal of the proposed study is to evaluate the efficacy and safety of Lamictal in neurotic excoriation. Twenty subjects with neurotic excoriation will receive 12 weeks of open-label treatment with Lamictal. The hypothesis to be tested is that Lamictal will be effective and well tolerated 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 or disease | Intervention/treatment | Phase |
|---|---|---|
| Neurotic Disorders Obsessive-Compulsive Disorder | Drug: Lamictal (lamotrigine) | Phase 2 |
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 25 participants |
| Allocation: | Non-Randomized |
| Intervention Model: | Single Group Assignment |
| Masking: | None (Open Label) |
| Primary Purpose: | Treatment |
| Official Title: | An Open-Label Study of Lamictal In Neurotic Excoriation |
| Study Start Date : | January 2006 |
| Actual Study Completion Date : | September 2006 |
Resource links provided by the National Library of Medicine
Drug Information available for:
Lamotrigine
Primary Outcome Measures :
- Yale-Brown Obsessive Compulsive Scale Modified for Neurotic Excoriation
Secondary Outcome Measures :
- Skin Picking Symptom Assessment Scale (SP-SAS) and the Clinical Global Impression scale
Information from the National Library of Medicine
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| Ages Eligible for Study: | 18 Years to 65 Years (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | Yes |
Criteria
Inclusion Criteria:
- men and women age 18-65
- current diagnosis of neurotic excoriation
Exclusion Criteria:
- 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
- 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 and
- patients who have previously been diagnosed with a medical condition that cause skin itchiness (e.g. liver, kidney, and blood diseases, etopic allergies)
Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00269594
Locations
| United States, Minnesota | |
| University of Minnesota | |
| Minneapolis, Minnesota, United States, 55454 | |
Sponsors and Collaborators
University of Minnesota - Clinical and Translational Science Institute
Investigators
| Principal Investigator: | Jon E Grant, JD, MD | University of Minnesota - Clinical and Translational Science Institute |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| ClinicalTrials.gov Identifier: | NCT00269594 History of Changes |
| Other Study ID Numbers: |
0510M77009 |
| First Posted: | December 23, 2005 Key Record Dates |
| Last Update Posted: | April 30, 2007 |
| Last Verified: | April 2007 |
Keywords provided by University of Minnesota - Clinical and Translational Science Institute:
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Skin Picking Pick Neurotic Excoriation |
Additional relevant MeSH terms:
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Disease Compulsive Personality Disorder Obsessive-Compulsive Disorder Dermatitis Self-Injurious Behavior Neurotic Disorders Pathologic Processes Personality Disorders Mental Disorders Anxiety Disorders Skin Diseases Behavioral Symptoms |
Lamotrigine Anticonvulsants Calcium Channel Blockers Membrane Transport Modulators Molecular Mechanisms of Pharmacological Action Excitatory Amino Acid Antagonists Excitatory Amino Acid Agents Neurotransmitter Agents Physiological Effects of Drugs Voltage-Gated Sodium Channel Blockers Sodium Channel Blockers |