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Augmentation of Brief Habit Reversal Training With D-cycloserine or Placebo (DCS+HRT)

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ClinicalTrials.gov Identifier: NCT02582515
Recruitment Status : Completed
First Posted : October 21, 2015
Results First Posted : April 25, 2019
Last Update Posted : April 25, 2019
Sponsor:
Information provided by (Responsible Party):
Joseph McGuire, University of California, Los Angeles

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Conditions Tourette Disorder
Chronic Tic Disorder
Interventions Drug: D-cycloserine
Drug: Placebo
Enrollment 20
Recruitment Details  
Pre-assignment Details  
Arm/Group Title D-cycloserine + Habit Reversal Training Placebo + Habit Reversal Training
Hide Arm/Group Description

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

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

Period Title: Overall Study
Started 9 11
Received Study Intervention 9 10
Completed 9 10
Not Completed 0 1
Reason Not Completed
Withdrawal by Subject             0             1
Arm/Group Title D-cycloserine + Habit Reversal Training Placebo + Habit Reversal Training Total
Hide Arm/Group Description

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

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 of all reporting groups
Overall Number of Baseline Participants 9 11 20
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 9 participants 11 participants 20 participants
<=18 years
9
 100.0%
11
 100.0%
20
 100.0%
Between 18 and 65 years
0
   0.0%
0
   0.0%
0
   0.0%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 9 participants 11 participants 20 participants
Female
0
   0.0%
3
  27.3%
3
  15.0%
Male
9
 100.0%
8
  72.7%
17
  85.0%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 9 participants 11 participants 20 participants
Hispanic or Latino
0
   0.0%
2
  18.2%
2
  10.0%
Not Hispanic or Latino
9
 100.0%
9
  81.8%
18
  90.0%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 9 participants 11 participants 20 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
Asian
3
  33.3%
1
   9.1%
4
  20.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
0
   0.0%
0
   0.0%
0
   0.0%
White
6
  66.7%
7
  63.6%
13
  65.0%
More than one race
0
   0.0%
3
  27.3%
3
  15.0%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 9 participants 11 participants 20 participants
9 11 20
Yale Global Tic Severity Scale Total Tic Score   [1] 
Mean (Standard Deviation)
Unit of measure:  Units on a scale
Number Analyzed 9 participants 11 participants 20 participants
21.89  (6.05) 18.27  (3.85) 19.90  (5.16)
[1]
Measure Description: The YGTSS is a clinician-administered scale of tic severity. It has two subscale scores of motor tic severity (range: 0-25) and phonic tic severity (range: 0-25) that are summed to produce a total tic score (range: 0-50). Higher total tic scores correspond with greater tic severity.
1.Primary Outcome
Title Hopkins Motor/Vocal Tic Scale (HM/VTS)
Hide Description

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

Time Frame Pre-treatment, One Week post-treatment
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title D-cycloserine + Habit Reversal Training Placebo + Habit Reversal Training
Hide Arm/Group Description:

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

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 Number of Participants Analyzed 9 10
Mean (Standard Deviation)
Unit of Measure: score on a scale
1.22  (0.62) 0.70  (0.54)
Time Frame Immediately after therapy session (Visit 2) and 1 week after therapy session (Visit 3)
Adverse Event Reporting Description Adverse events were systematically assessed at Visits 2 and 3 using side effect review form derived from the Safety Monitoring Uniform Report Form (SMURF).
 
Arm/Group Title D-cycloserine + Habit Reversal Training Placebo + Habit Reversal Training
Hide Arm/Group Description

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

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

All-Cause Mortality
D-cycloserine + Habit Reversal Training Placebo + Habit Reversal Training
Affected / at Risk (%) Affected / at Risk (%)
Total   0/9 (0.00%)      0/10 (0.00%)    
Show Serious Adverse Events Hide Serious Adverse Events
D-cycloserine + Habit Reversal Training Placebo + Habit Reversal Training
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/9 (0.00%)      0/10 (0.00%)    
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
D-cycloserine + Habit Reversal Training Placebo + Habit Reversal Training
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   3/9 (33.33%)      0/10 (0.00%)    
General disorders     
Drowsiness   1/9 (11.11%)  1 0/10 (0.00%)  0
Difficulty Falling Asleep   1/9 (11.11%)  1 0/10 (0.00%)  0
Sore Throat   1/9 (11.11%)  1 0/10 (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
Name/Title: Assistant Professor
Organization: Johns Hopkins University School of Medicine
Phone: 443-287-5143
Responsible Party: Joseph McGuire, University of California, Los Angeles
ClinicalTrials.gov Identifier: NCT02582515     History of Changes
Other Study ID Numbers: UCLA_DCS+HRT
First Submitted: October 16, 2015
First Posted: October 21, 2015
Results First Submitted: March 11, 2019
Results First Posted: April 25, 2019
Last Update Posted: April 25, 2019