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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Sponsor:
University of Chicago
Information provided by (Responsible Party):
Jon Grant, University of Chicago
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Study Type | Interventional |
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Study Design | Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Double (Participant, Investigator); Primary Purpose: Treatment |
Conditions |
Neurotic Excoriation Pathologic Skin Picking Psychogenic Excoriation Dermatillomania |
Interventions |
Drug: Lamictal (lamotrigine) Drug: Placebo |
Enrollment | 35 |
Participant Flow
Recruitment Details | August 2007 - July 2009 |
Pre-assignment Details |
Arm/Group Title | Lamictal | Placebo |
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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 |
Reason Not Completed | ||
Adverse Event | 1 | 0 |
Withdrawal by Subject | 4 | 5 |
Baseline Characteristics
Arm/Group Title | Lamictal | Placebo | Total | |
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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 Number of Baseline Participants | 17 | 18 | 35 | |
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[Not Specified]
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Age, Categorical
Measure Type: Count of Participants Unit of measure: Participants |
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Number Analyzed | 17 participants | 18 participants | 35 participants | |
<=18 years |
0 0.0%
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0 0.0%
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0 0.0%
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Between 18 and 65 years |
17 100.0%
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18 100.0%
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35 100.0%
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>=65 years |
0 0.0%
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0 0.0%
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0 0.0%
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Age Continuous
Mean (Standard Deviation) Unit of measure: Years |
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Number Analyzed | 17 participants | 18 participants | 35 participants | |
33.2 (14.1) | 31.6 (13.3) | 32.8 (13.3) | ||
Sex: Female, Male
Measure Type: Count of Participants Unit of measure: Participants |
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Number Analyzed | 17 participants | 18 participants | 35 participants | |
Female |
16 94.1%
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16 88.9%
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32 91.4%
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Male |
1 5.9%
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2 11.1%
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3 8.6%
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Region of Enrollment
Measure Type: Number Unit of measure: Participants |
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United States | Number Analyzed | 17 participants | 18 participants | 35 participants |
17 | 18 | 35 |
Outcome Measures
Adverse Events
Limitations and Caveats
[Not Specified]
More Information
Results Point of Contact
Name/Title: | Jon E. Grant |
Organization: | University of Minnesota |
Phone: | 612-273-9800 |
EMail: | grant045@umn.edu |
Responsible Party: | Jon Grant, University of Chicago |
ClinicalTrials.gov Identifier: | NCT00513019 |
Other Study ID Numbers: |
0703M03384 |
First Submitted: | August 7, 2007 |
First Posted: | August 8, 2007 |
Results First Submitted: | March 1, 2012 |
Results First Posted: | September 27, 2013 |
Last Update Posted: | September 27, 2013 |