Trial Outcomes & Findings for Augmentation of Brief Habit Reversal Training With D-cycloserine or Placebo (NCT NCT02582515)
NCT ID: NCT02582515
Last Updated: 2019-04-25
Results Overview
Participants can nominate up to five motor and five vocal tics they deem bothersome on the HM/VTS. Each bothersome tic is then rated by a clinician on a 5-point scale ranging from none (0) to severe (4). The individual tic scores are summed (minimum of 0 and maximum of 40) and averaged together to create an average tic severity score. Lower scores represent less tic severity, and higher scores indicate greater tic severity. The primary outcome will be the difference in the average score of the two bothersome tics on the HM/VTS that were targeted in treatment (range: 0-8). Change scores were calculated by subtracting the average of the two bothersome tics on the HM/VTS at post-treatment from the average of the two bothersome tics on the HM/VTS at the pre-treatment assessment. Positive scores indicate improvement/decrease in targeted tic severity, with negative scores indicating increase in targeted tic severity
COMPLETED
NA
20 participants
Pre-treatment, One Week post-treatment
2019-04-25
Participant Flow
Participant milestones
| Measure |
D-cycloserine + Habit Reversal Training
Participants randomly assigned to the D-cycloserine (DCS) condition will receive a single dose of DCS immediately prior to a single session of habit reversal training. Participants will be evaluated 1 week later for improvement in tics targeted in the treatment session.
D-cycloserine
|
Placebo + Habit Reversal Training
Participants randomly assigned to the placebo condition will receive a single dose of placebo immediately prior to a single session of habit reversal training. Participants will be evaluated 1 week later for improvement in tics targeted in the treatment session.
Placebo
|
|---|---|---|
|
Overall Study
STARTED
|
9
|
11
|
|
Overall Study
Received Study Intervention
|
9
|
10
|
|
Overall Study
COMPLETED
|
9
|
10
|
|
Overall Study
NOT COMPLETED
|
0
|
1
|
Reasons for withdrawal
| Measure |
D-cycloserine + Habit Reversal Training
Participants randomly assigned to the D-cycloserine (DCS) condition will receive a single dose of DCS immediately prior to a single session of habit reversal training. Participants will be evaluated 1 week later for improvement in tics targeted in the treatment session.
D-cycloserine
|
Placebo + Habit Reversal Training
Participants randomly assigned to the placebo condition will receive a single dose of placebo immediately prior to a single session of habit reversal training. Participants will be evaluated 1 week later for improvement in tics targeted in the treatment session.
Placebo
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
0
|
1
|
Baseline Characteristics
Augmentation of Brief Habit Reversal Training With D-cycloserine or Placebo
Baseline characteristics by cohort
| Measure |
D-cycloserine + Habit Reversal Training
n=9 Participants
Participants randomly assigned to the D-cycloserine (DCS) condition will receive a single dose of DCS immediately prior to a single session of habit reversal training. Participants will be evaluated 1 week later for improvement in tics targeted in the treatment session.
D-cycloserine
|
Placebo + Habit Reversal Training
n=11 Participants
Participants randomly assigned to the placebo condition will receive a single dose of placebo immediately prior to a single session of habit reversal training. Participants will be evaluated 1 week later for improvement in tics targeted in the treatment session.
Placebo
|
Total
n=20 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
9 Participants
n=93 Participants
|
11 Participants
n=4 Participants
|
20 Participants
n=27 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=93 Participants
|
3 Participants
n=4 Participants
|
3 Participants
n=27 Participants
|
|
Sex: Female, Male
Male
|
9 Participants
n=93 Participants
|
8 Participants
n=4 Participants
|
17 Participants
n=27 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=93 Participants
|
2 Participants
n=4 Participants
|
2 Participants
n=27 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
9 Participants
n=93 Participants
|
9 Participants
n=4 Participants
|
18 Participants
n=27 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Asian
|
3 Participants
n=93 Participants
|
1 Participants
n=4 Participants
|
4 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
White
|
6 Participants
n=93 Participants
|
7 Participants
n=4 Participants
|
13 Participants
n=27 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=93 Participants
|
3 Participants
n=4 Participants
|
3 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Region of Enrollment
United States
|
9 participants
n=93 Participants
|
11 participants
n=4 Participants
|
20 participants
n=27 Participants
|
|
Yale Global Tic Severity Scale Total Tic Score
|
21.89 units on a scale
STANDARD_DEVIATION 6.05 • n=93 Participants
|
18.27 units on a scale
STANDARD_DEVIATION 3.85 • n=4 Participants
|
19.90 units on a scale
STANDARD_DEVIATION 5.16 • n=27 Participants
|
PRIMARY outcome
Timeframe: Pre-treatment, One Week post-treatmentParticipants can nominate up to five motor and five vocal tics they deem bothersome on the HM/VTS. Each bothersome tic is then rated by a clinician on a 5-point scale ranging from none (0) to severe (4). The individual tic scores are summed (minimum of 0 and maximum of 40) and averaged together to create an average tic severity score. Lower scores represent less tic severity, and higher scores indicate greater tic severity. The primary outcome will be the difference in the average score of the two bothersome tics on the HM/VTS that were targeted in treatment (range: 0-8). Change scores were calculated by subtracting the average of the two bothersome tics on the HM/VTS at post-treatment from the average of the two bothersome tics on the HM/VTS at the pre-treatment assessment. Positive scores indicate improvement/decrease in targeted tic severity, with negative scores indicating increase in targeted tic severity
Outcome measures
| Measure |
D-cycloserine + Habit Reversal Training
n=9 Participants
Participants randomly assigned to the D-cycloserine (DCS) condition will receive a single dose of DCS immediately prior to a single session of habit reversal training. Participants will be evaluated 1 week later for improvement in tics targeted in the treatment session.
D-cycloserine
|
Placebo + Habit Reversal Training
n=10 Participants
Participants randomly assigned to the placebo condition will receive a single dose of placebo immediately prior to a single session of habit reversal training. Participants will be evaluated 1 week later for improvement in tics targeted in the treatment session.
Placebo
|
|---|---|---|
|
Hopkins Motor/Vocal Tic Scale (HM/VTS)
|
1.22 score on a scale
Standard Deviation 0.62
|
0.70 score on a scale
Standard Deviation 0.54
|
Adverse Events
D-cycloserine + Habit Reversal Training
Placebo + Habit Reversal Training
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
D-cycloserine + Habit Reversal Training
n=9 participants at risk
Participants randomly assigned to the D-cycloserine (DCS) condition will receive a single dose of DCS immediately prior to a single session of habit reversal training. Participants will be evaluated 1 week later for improvement in tics targeted in the treatment session.
D-cycloserine
|
Placebo + Habit Reversal Training
n=10 participants at risk
Participants randomly assigned to the placebo condition will receive a single dose of placebo immediately prior to a single session of habit reversal training. Participants will be evaluated 1 week later for improvement in tics targeted in the treatment session.
Placebo
|
|---|---|---|
|
General disorders
Drowsiness
|
11.1%
1/9 • Number of events 1 • Immediately after therapy session (Visit 2) and 1 week after therapy session (Visit 3)
Adverse events were systematically assessed at Visits 2 and 3 using side effect review form derived from the Safety Monitoring Uniform Report Form (SMURF).
|
0.00%
0/10 • Immediately after therapy session (Visit 2) and 1 week after therapy session (Visit 3)
Adverse events were systematically assessed at Visits 2 and 3 using side effect review form derived from the Safety Monitoring Uniform Report Form (SMURF).
|
|
General disorders
Difficulty Falling Asleep
|
11.1%
1/9 • Number of events 1 • Immediately after therapy session (Visit 2) and 1 week after therapy session (Visit 3)
Adverse events were systematically assessed at Visits 2 and 3 using side effect review form derived from the Safety Monitoring Uniform Report Form (SMURF).
|
0.00%
0/10 • Immediately after therapy session (Visit 2) and 1 week after therapy session (Visit 3)
Adverse events were systematically assessed at Visits 2 and 3 using side effect review form derived from the Safety Monitoring Uniform Report Form (SMURF).
|
|
General disorders
Sore Throat
|
11.1%
1/9 • Number of events 1 • Immediately after therapy session (Visit 2) and 1 week after therapy session (Visit 3)
Adverse events were systematically assessed at Visits 2 and 3 using side effect review form derived from the Safety Monitoring Uniform Report Form (SMURF).
|
0.00%
0/10 • Immediately after therapy session (Visit 2) and 1 week after therapy session (Visit 3)
Adverse events were systematically assessed at Visits 2 and 3 using side effect review form derived from the Safety Monitoring Uniform Report Form (SMURF).
|
Additional Information
Assistant Professor
Johns Hopkins University School of Medicine
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place