- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00269594
An Open-Label Study Of Lamictal In Neurotic Excoriation
April 27, 2007 updated by: University of Minnesota
An Open-Label Study of Lamictal In Neurotic Excoriation
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
25
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Minnesota
-
Minneapolis, Minnesota, United States, 55454
- University of Minnesota
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
16 years to 63 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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)
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
---|
Yale-Brown Obsessive Compulsive Scale Modified for Neurotic Excoriation
|
Secondary Outcome Measures
Outcome Measure |
---|
Skin Picking Symptom Assessment Scale (SP-SAS) and the Clinical Global Impression scale
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Jon E Grant, JD, MD, University of Minnesota
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
January 1, 2006
Study Completion (Actual)
September 1, 2006
Study Registration Dates
First Submitted
December 22, 2005
First Submitted That Met QC Criteria
December 22, 2005
First Posted (Estimate)
December 23, 2005
Study Record Updates
Last Update Posted (Estimate)
April 30, 2007
Last Update Submitted That Met QC Criteria
April 27, 2007
Last Verified
April 1, 2007
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Mental Disorders
- Pathologic Processes
- Anxiety Disorders
- Disease
- Obsessive-Compulsive Disorder
- Neurotic Disorders
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Central Nervous System Depressants
- Antipsychotic Agents
- Tranquilizing Agents
- Psychotropic Drugs
- Membrane Transport Modulators
- Anticonvulsants
- Sodium Channel Blockers
- Calcium-Regulating Hormones and Agents
- Calcium Channel Blockers
- Lamotrigine
Other Study ID Numbers
- 0510M77009
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Obsessive-Compulsive Disorder
-
Anne Katrine PagsbergCopenhagen Trial Unit, Center for Clinical Intervention Research; Danish Research...Active, not recruitingObsessive-Compulsive Disorder in Children | Obsessive-Compulsive Disorder in AdolescenceDenmark
-
Baylor College of MedicineRecruitingObsessive-Compulsive Disorder | Cognitive Behavioral Therapy | Obsessive-Compulsive Disorder in Children | Obsessive-Compulsive Disorder in AdolescenceUnited States
-
Chaim HuijserLevvelRecruitingObsessive-Compulsive Disorder | Anxiety Disorders and Symptoms | Obsessive-Compulsive Disorder in Children | Obsessive-Compulsive Disorder in AdolescenceNetherlands
-
Stanford UniversityCompletedObsessive Compulsive DisorderUnited States
-
NYU Langone HealthCompletedObsessive Compulsive DisorderUnited States
-
Massachusetts General HospitalActive, not recruitingObsessive Compulsive DisorderUnited States
-
Boston University Charles River CampusCompletedObsessive Compulsive DisorderUnited States
-
Butler HospitalNational Institute of Mental Health (NIMH)CompletedObsessive Compulsive DisorderUnited States
-
Karolinska InstitutetCompletedObsessive Compulsive DisorderSweden
-
Roseli ShavittCompleted
Clinical Trials on Lamictal (lamotrigine)
-
University of Maryland, BaltimoreCompleted
-
United PharmaceuticalsStatitecUnknownGastroesophageal Reflux in Children
-
Thomas Jefferson UniversityCompletedTrigeminal NeuralgiaUnited States
-
University of ChicagoCompletedDermatillomania | Pathologic Skin Picking | Neurotic Excoriation | Psychogenic ExcoriationUnited States
-
University Hospitals Cleveland Medical CenterGlaxoSmithKlineCompletedBipolar Disorder | Depression, BipolarUnited States
-
GlaxoSmithKlineCompleted
-
Alembic Pharmaceuticals Ltd.Completed
-
GlaxoSmithKlineCompleted
-
Massachusetts General HospitalCompletedBipolar Disorder | ManiaUnited States
-
GlaxoSmithKlineCompletedEpilepsy, Tonic-ClonicUnited States, Germany, Korea, Republic of, Chile, India, Russian Federation, Brazil, Ukraine, Puerto Rico, Argentina, Malaysia