Double-Blind Lamictal (Lamotrigine) in Neurotic Excoriation

• Sponsor: University of Chicago (Other)
• Overall Status: Completed
• CT.gov ID: NCT00513019
• Collaborator: (none)
• Enrollment: 35
• Location: 1
• Arms: 2
• Duration (Months): 25
• Patients Per Site Per Month: 1.4

Study Details

Study Description

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

• Study Type: Interventional
• 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: Aug 1, 2007
• Actual Primary Completion Date: Aug 1, 2009
• Actual Study Completion Date: Sep 1, 2009

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: 1 Lamictal (lamotrigine)	Drug: Lamictal (lamotrigine); once daily from beginning to end of study. Dosage varies.; Other Names: lamotrigine
Placebo Comparator: 2 Placebo	Drug: Placebo; daily

Outcome Measures

Primary Outcome Measures

1. The Yale-Brown Obsessive Compulsive Scale Modified for Neurotic Excoriation (NE-YBOCS) Will be the Primary Outcome Measure [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

Criteria

• Ages Eligible for Study: 18 Years to 65 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Locations

	Site	City	State	Country	Postal Code
1	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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Jon Grant, Professor of Psychiatry, University of Chicago
• ClinicalTrials.gov Identifier: NCT00513019
• Other Study ID Numbers: 0703M03384
• First Posted: Aug 8, 2007
• Last Update Posted: Sep 27, 2013
• Last Verified: Aug 1, 2013

• Keywords provided by Jon Grant, Professor of Psychiatry, University of Chicago: Neurotic Excoriation; Pathologic Skin Picking; Psychogenic Excoriation
• Additional relevant MeSH terms: Dermatitis; Self-Injurious Behavior; Lamotrigine; Anticonvulsants

Study Results

Participant Flow

Recruitment Details	August 2007 - July 2009

Arm/Group Title	Lamictal	Placebo
Arm/Group Description	The subjects began lamotrigine at 25 mg/d every other day for 1 week. At week 1, the dose was raised to 25 mg/d. At week 2, the dose was raised to 50 mg/d for 2 weeks. Thereafter, all visits were scheduled every 2 weeks at which times the dose could be increased to 100 mg/d, then 200 mg/d, and finally 300 mg/d unless clinical improvement was attained at a lower dose (clinical improvement was assessed by the investigator with respect to skin picking behavior, thoughts, and urges).	Placebo pills (identical to lamictal pills) were taken by mouth once daily.
Period Title: Overall Study
STARTED	17	18
COMPLETED	12	13
NOT COMPLETED	5	5

Baseline Characteristics

Arm/Group Title	Lamictal	Placebo	Total
Arm/Group Description	The subjects began lamotrigine at 25 mg/d every other day for 1 week. At week 1, the dose was raised to 25 mg/d. At week 2, the dose was raised to 50 mg/d for 2 weeks. Thereafter, all visits were scheduled every 2 weeks at which times the dose could be increased to 100 mg/d, then 200 mg/d, and finally 300 mg/d unless clinical improvement was attained at a lower dose (clinical improvement was assessed by the investigator with respect to skin picking behavior, thoughts, and urges).	Placebo pills (identical to lamictal pills) were taken by mouth once daily.	Total of all reporting groups
Overall Participants	17	18	35
Age (Count of Participants)
<=18 years	0 0%	0 0%	0 0%
Between 18 and 65 years	17 100%	18 100%	35 100%
>=65 years	0 0%	0 0%	0 0%
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	33.2 (14.1)	31.6 (13.3)	32.8 (13.3)
Sex: Female, Male (Count of Participants)
Female	16 94.1%	16 88.9%	32 91.4%
Male	1 5.9%	2 11.1%	3 8.6%
Region of Enrollment (participants) [Number]
United States	17 100%	18 100%	35 100%

Outcome Measures

1. Primary Outcome

Title	The Yale-Brown Obsessive Compulsive Scale Modified for Neurotic Excoriation (NE-YBOCS) Will be the Primary Outcome Measure
Description	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).
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.

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Lamictal	Placebo
Arm/Group Description	The subjects began lamotrigine at 25 mg/d every other day for 1 week. At week 1, the dose was raised to 25 mg/d. At week 2, the dose was raised to 50 mg/d for 2 weeks. Thereafter, all visits were scheduled every 2 weeks at which times the dose could be increased to 100 mg/d, then 200 mg/d, and finally 300 mg/d unless clinical improvement was attained at a lower dose (clinical improvement was assessed by the investigator with respect to skin picking behavior, thoughts, and urges).	Placebo pills (identical to lamictal pills) were taken by mouth once daily.
Measure Participants	17	18
Mean (Standard Deviation) [units on a scale]	15.25 (4.1)	16.13 (3.6)

Adverse Events

Arm/Group Title	Lamictal		Placebo
Arm/Group Description	The subjects began lamotrigine at 25 mg/d every other day for 1 week. At week 1, the dose was raised to 25 mg/d. At week 2, the dose was raised to 50 mg/d for 2 weeks. Thereafter, all visits were scheduled every 2 weeks at which times the dose could be increased to 100 mg/d, then 200 mg/d, and finally 300 mg/d unless clinical improvement was attained at a lower dose (clinical improvement was assessed by the investigator with respect to skin picking behavior, thoughts, and urges).		Placebo pills (identical to lamictal pills) were taken by mouth once daily.
All Cause Mortality
	Lamictal		Placebo
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)
Serious Adverse Events
	Lamictal		Placebo
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/17 (0%)		0/18 (0%)
Other (Not Including Serious) Adverse Events
	Lamictal		Placebo
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	1/17 (5.9%)		0/18 (0%)
Psychiatric disorders
Disorientation	1/16 (6.3%)	1	0/16 (0%)	0

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.