Double-Blind Lamictal (Lamotrigine) in Neurotic Excoriation

Study Description

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Brief Summary:

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 or disease	Intervention/treatment	Phase
Neurotic Excoriation; Pathologic Skin Picking; Psychogenic Excoriation; Dermatillomania	Drug: Lamictal (lamotrigine); Drug: Placebo	Phase 2

Detailed Description:

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.

Study Design

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Study Type :	Interventional (Clinical Trial)
Actual Enrollment :	35 participants
Allocation:	Randomized
Intervention Model:	Parallel Assignment
Masking:	Double (Participant, Investigator)
Primary Purpose:	Treatment
Official Title:	A Double-Blind Study of Lamictal in Neurotic Excoriation
Study Start Date :	August 2007
Actual Primary Completion Date :	August 2009
Actual Study Completion Date :	September 2009

Arms and Interventions

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm	Intervention/treatment
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

Outcome Measures

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Primary Outcome Measures :

1. The Yale-Brown Obsessive Compulsive Scale Modified for Neurotic Excoriation (NE-YBOCS) Will be the Primary Outcome Measure [ Time Frame: beginning and at each visit until the end of their participation in the study (12-weeks); investigator rated. Note: Reported mean and standard deviation is the final reported data point. ]
   The Yale-Brown Obsessive Compulsive Scale Modified for Neurotic Excoriation (NE-YBOCS) was the primary outcome measure - severity of illness. The NE-YBOCS is a reliable and valid, 10-item, clinician-administered scale that rates buying symptoms within the last seven days, on a severity scale from 0 to 4 for each item (total scores range from 0 to 40 with higher scores reflecting greater illness severity).

Eligibility Criteria

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Ages Eligible for Study:	18 Years to 65 Years (Adult)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

1. men and women age 18-65;
2. current diagnosis of neurotic excoriation.

Exclusion Criteria:

1. unstable medical illness or clinically significant abnormalities on prestudy laboratory tests or physical examination;
2. history of seizures;
3. myocardial infarction within 6 months;
4. current pregnancy or lactation, or inadequate contraception in women of childbearing potential;
5. a need for medication other than Lamictal with possible psychotropic effects or unfavorable interactions with Lamictal;
6. clinically significant suicidality;
7. lifetime history of DSM-IV bipolar disorder type I, dementia, or schizophrenia or any other DSM-IV psychotic disorder;
8. current or recent (past 3 months) DSM-IV substance abuse or dependence;
9. illegal substance use within 2 weeks of study initiation;
10. initiation of psychotherapy or behavior therapy from a mental health professional within 3 months prior to study baseline;
11. previous treatment with Lamictal (lamotrigine);
12. 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;
13. current treatment with an anti-epileptic medication.

Contacts and Locations

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Locations

United States, Minnesota
Ambulatory Research Center
Minneapolis, Minnesota, United States, 55454

Sponsors and Collaborators

University of Chicago

Investigators

Principal Investigator:	Jon E Grant, M.D.	University of Minnesota - Clinical and Translational Science Institute

More Information

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Responsible Party:	Jon Grant, Professor of Psychiatry, University of Chicago
ClinicalTrials.gov Identifier:	NCT00513019 History of Changes
Other Study ID Numbers:	0703M03384
First Posted:	August 8, 2007
Results First Posted:	September 27, 2013
Last Update Posted:	September 27, 2013
Last Verified:	August 2013

Keywords provided by Jon Grant, University of Chicago:

Neurotic Excoriation; Pathologic Skin Picking; Psychogenic Excoriation

Additional relevant MeSH terms:

Dermatitis; Self-Injurious Behavior; 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