MedDataX Logo

An Open-Label Study Of Lamictal In Neurotic Excoriation

NCT ID: NCT00269594

Last Updated: 2007-04-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

25 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-01-31

Study Completion Date

2006-09-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Neurotic Disorders Obsessive-Compulsive Disorder

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

Skin Picking Pick Neurotic Excoriation

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Lamictal (lamotrigine)

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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)
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

University of Minnesota

OTHER

Sponsor Role lead

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Jon E Grant, JD, MD

Role: PRINCIPAL_INVESTIGATOR

University of Minnesota

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

University of Minnesota

Minneapolis, Minnesota, United States

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States

References

Explore related publications, articles, or registry entries linked to this study.

Grant JE, Odlaug BL, Kim SW. Lamotrigine treatment of pathologic skin picking: an open-label study. J Clin Psychiatry. 2007 Sep;68(9):1384-91. doi: 10.4088/jcp.v68n0909.

Reference Type DERIVED
PMID: 17915977 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

0510M77009

Identifier Type: -

Identifier Source: org_study_id