Double-Blind Lamictal (Lamotrigine) in Neurotic Excoriation
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ClinicalTrials.gov Identifier: NCT00513019 |
Recruitment Status :
Completed
First Posted : August 8, 2007
Results First Posted : September 27, 2013
Last Update Posted : September 27, 2013
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Neurotic Excoriation Pathologic Skin Picking Psychogenic Excoriation Dermatillomania | Drug: Lamictal (lamotrigine) Drug: Placebo | Phase 2 |
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 |

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 |
- 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).

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Ages Eligible for Study: | 18 Years to 65 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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 (lamotrigine);
- 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.

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): NCT00513019
United States, Minnesota | |
Ambulatory Research Center | |
Minneapolis, Minnesota, United States, 55454 |
Principal Investigator: | Jon E Grant, M.D. | University of Minnesota |
Responsible Party: | Jon Grant, Professor of Psychiatry, University of Chicago |
ClinicalTrials.gov Identifier: | NCT00513019 |
Other Study ID Numbers: |
0703M03384 |
First Posted: | August 8, 2007 Key Record Dates |
Results First Posted: | September 27, 2013 |
Last Update Posted: | September 27, 2013 |
Last Verified: | August 2013 |
Neurotic Excoriation Pathologic Skin Picking Psychogenic Excoriation |
Dermatitis Self-Injurious Behavior Skin Diseases Behavioral Symptoms Lamotrigine Anticonvulsants Calcium Channel Blockers Membrane Transport Modulators |
Molecular Mechanisms of Pharmacological Action Calcium-Regulating Hormones and Agents Physiological Effects of Drugs Antipsychotic Agents Tranquilizing Agents Central Nervous System Depressants Psychotropic Drugs Sodium Channel Blockers |