Trial Outcomes & Findings for Double-Blind Lamictal (Lamotrigine) in Neurotic Excoriation (NCT NCT00513019)
NCT ID: NCT00513019
Last Updated: 2023-02-23
Results Overview
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).
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
35 participants
Primary outcome timeframe
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.
Results posted on
2023-02-23
Participant Flow
August 2007 - July 2009
Participant milestones
| Measure |
Lamictal
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
Placebo pills (identical to lamictal pills) were taken by mouth once daily.
|
|---|---|---|
|
Overall Study
STARTED
|
17
|
18
|
|
Overall Study
COMPLETED
|
12
|
13
|
|
Overall Study
NOT COMPLETED
|
5
|
5
|
Reasons for withdrawal
| Measure |
Lamictal
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
Placebo pills (identical to lamictal pills) were taken by mouth once daily.
|
|---|---|---|
|
Overall Study
Adverse Event
|
1
|
0
|
|
Overall Study
Withdrawal by Subject
|
4
|
5
|
Baseline Characteristics
Double-Blind Lamictal (Lamotrigine) in Neurotic Excoriation
Baseline characteristics by cohort
| Measure |
Lamictal
n=17 Participants
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
n=18 Participants
Placebo pills (identical to lamictal pills) were taken by mouth once daily.
|
Total
n=35 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
17 Participants
n=5 Participants
|
18 Participants
n=7 Participants
|
35 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Continuous
|
33.2 years
STANDARD_DEVIATION 14.1 • n=5 Participants
|
31.6 years
STANDARD_DEVIATION 13.3 • n=7 Participants
|
32.8 years
STANDARD_DEVIATION 13.3 • n=5 Participants
|
|
Sex: Female, Male
Female
|
16 Participants
n=5 Participants
|
16 Participants
n=7 Participants
|
32 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
17 participants
n=5 Participants
|
18 participants
n=7 Participants
|
35 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 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).
Outcome measures
| Measure |
Lamictal
n=17 Participants
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
n=18 Participants
Placebo pills (identical to lamictal pills) were taken by mouth once daily.
|
|---|---|---|
|
The Yale-Brown Obsessive Compulsive Scale Modified for Neurotic Excoriation (NE-YBOCS) Will be the Primary Outcome Measure
|
15.25 units on a scale
Standard Deviation 4.1
|
16.13 units on a scale
Standard Deviation 3.6
|
Adverse Events
Lamictal
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Placebo
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Lamictal
n=17 participants at risk
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
n=18 participants at risk
Placebo pills (identical to lamictal pills) were taken by mouth once daily.
|
|---|---|---|
|
Psychiatric disorders
Disorientation
|
6.2%
1/16 • Number of events 1
|
0.00%
0/16
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place