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Trial record 68 of 215 for:    Lamotrigine

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
Sponsor:
Information provided by (Responsible Party):
Jon Grant, University of Chicago

Study Type Interventional
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
Recruitment Details August 2007 - July 2009
Pre-assignment Details  
Arm/Group Title Lamictal Placebo
Hide 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
Reason Not Completed
Adverse Event             1             0
Withdrawal by Subject             4             5
Arm/Group Title Lamictal Placebo Total
Hide 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 Number of Baseline Participants 17 18 35
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 17 participants 18 participants 35 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
17
 100.0%
18
 100.0%
35
 100.0%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
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
Number Analyzed 17 participants 18 participants 35 participants
Female
16
  94.1%
16
  88.9%
32
  91.4%
Male
1
   5.9%
2
  11.1%
3
   8.6%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 17 participants 18 participants 35 participants
17 18 35
1.Primary Outcome
Title The Yale-Brown Obsessive Compulsive Scale Modified for Neurotic Excoriation (NE-YBOCS) Will be the Primary Outcome Measure
Hide 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.
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Lamictal Placebo
Hide 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.
Overall Number of Participants Analyzed 17 18
Mean (Standard Deviation)
Unit of Measure: units on a scale
15.25  (4.1) 16.13  (3.6)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Lamictal Placebo
Hide 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 (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Lamictal Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/17 (0.00%)      0/18 (0.00%)    
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Lamictal Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   1/17 (5.88%)      0/18 (0.00%)    
Psychiatric disorders     
Disorientation   1/16 (6.25%)  1 0/16 (0.00%)  0
Indicates events were collected by systematic assessment
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.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Jon E. Grant
Organization: University of Minnesota
Phone: 612-273-9800
EMail: grant045@umn.edu
Layout table for additonal information
Responsible Party: Jon Grant, University of Chicago
ClinicalTrials.gov Identifier: NCT00513019     History of Changes
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