Double-Blind Lamictal (Lamotrigine) in Neurotic Excoriation

• ClinicalTrials.gov Identifier: NCT00513019
• Recruitment Status: Completed
• First Posted: August 8, 2007
• Results First Posted: September 27, 2013
• Last Update Posted: September 27, 2013
• Sponsor: University of Chicago
• Information provided by (Responsible Party): Jon Grant, University of Chicago

Tracking Information

• First Submitted Date: August 7, 2007
• First Posted Date: August 8, 2007
• Results First Submitted Date: March 1, 2012
• Results First Posted Date: September 27, 2013
• Last Update Posted Date: September 27, 2013
• Study Start Date: August 2007
• Actual Primary Completion Date: August 2009 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: August 6, 2013)

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).

• Original Primary Outcome Measures (submitted: August 7, 2007): The Yale-Brown Obsessive Compulsive Scale Modified for Neurotic Excoriation (NE-YBOCS) Will be the Primary Outcome Measure
• Current Secondary Outcome Measures: Not Provided
• Original Secondary Outcome Measures: Not Provided
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Double-Blind Lamictal (Lamotrigine) in Neurotic Excoriation
• Official Title: A Double-Blind Study of Lamictal in Neurotic Excoriation
• 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.
• 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 Type: Interventional
• Study Phase: Phase 2
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Double (Participant, Investigator); Primary Purpose: Treatment

Condition

• Neurotic Excoriation
• Pathologic Skin Picking
• Psychogenic Excoriation
• Dermatillomania

Intervention

• Drug: Lamictal (lamotrigine)
  once daily from beginning to end of study. Dosage varies.
  Other Name: lamotrigine
• Drug: Placebo
  daily

Study Arms

• Active Comparator: 1
  Lamictal (lamotrigine)
  Intervention: Drug: Lamictal (lamotrigine)
• Placebo Comparator: 2
  Placebo
  Intervention: Drug: Placebo

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: March 23, 2010): 35
• Original Estimated Enrollment (submitted: August 7, 2007): 30
• Actual Study Completion Date: September 2009
• Actual Primary Completion Date: August 2009 (Final data collection date for primary outcome measure)

Eligibility 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.

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years to 65 Years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT00513019
• Other Study ID Numbers: 0703M03384
• Has Data Monitoring Committee: Yes
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Responsible Party: Jon Grant, University of Chicago
• Study Sponsor: University of Chicago
• Collaborators: Not Provided

Investigators

• Principal Investigator: Jon E Grant, M.D.; University of Minnesota

• PRS Account: University of Chicago
• Verification Date: August 2013