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D-cycloserine Augmented Treatment for Youth With Tic Disorders

Primary Purpose

Tourette Syndrome

Status
Withdrawn
Phase
Early Phase 1
Locations
United States
Study Type
Interventional
Intervention
d-cycloserine
Placebo pill
Behavior Therapy
Sponsored by
Johns Hopkins University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Tourette Syndrome focused on measuring habit reversal training, Comprehensive Behavioral Intervention for Tics, d-cycloserine, behavior therapy

Eligibility Criteria

8 Years - 17 Years (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 8-17 years
  • Meet Diagnostic and Statistical Manual of Mental Disorders (DSM)-5 criteria for Tourette's Disorder, Persistent Motor Tic Disorder, or Persistent Vocal Tic Disorder
  • Have moderate tic severity or greater as evidenced by a Yale Global Tic Severity Scale (YGTSS) total score greater than 13 (>9 for children with motor or vocal tics only)
  • Be fluent in English

Exclusion Criteria:

  • Current diagnosis of substance abuse/dependence
  • Lifetime diagnosis of autism spectrum disorder, mania or psychosis
  • History of a seizure disorder, kidney disease, or liver disease
  • Four or more previous sessions of behavior therapy

Sites / Locations

  • Johns Hopkins University School of Medicine

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Behavior Therapy + DCS

Behavior Therapy + Placebo

Arm Description

Youth with TD will receive four, 2-hour long sessions of evidence-based behavior therapy delivered in an intensive format. Participants will arrive an hour early for each session to take the d-cycloserine pill prior to starting each session of behavior therapy. Participants, therapists, and outcome assessors will be masked to pill condition.

Youth with TD will receive four, 2-hour long sessions of evidence-based behavior therapy delivered in an intensive format. Participants will arrive an hour early for each session to take the placebo pill prior to starting each session of behavior therapy. Participants, therapists, and outcome assessors will be masked to pill condition.

Outcomes

Primary Outcome Measures

Change in Hopkins Motor/Vocal Tic Scale (HM/VTS) score
Participants can nominate up to five motor and five vocal tics participants 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.

Secondary Outcome Measures

Full Information

First Posted
April 20, 2020
Last Updated
April 12, 2023
Sponsor
Johns Hopkins University
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1. Study Identification

Unique Protocol Identification Number
NCT04357951
Brief Title
D-cycloserine Augmented Treatment for Youth With Tic Disorders
Official Title
D-cycloserine Augmented Treatment: Enhancing Extinction Learning in Youth With Tic Disorders
Study Type
Interventional

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Withdrawn
Why Stopped
Low enrollment
Study Start Date
April 15, 2023 (Anticipated)
Primary Completion Date
March 2024 (Anticipated)
Study Completion Date
September 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Johns Hopkins University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
This pilot study aims evaluate the feasibility and initial efficacy of behavior therapy augmented by d-cycloserine (DCS) compared to behavior therapy augmented by placebo. After an initial assessment to determine eligibility, youth with TD will be randomly assigned to receive four sessions of behavior therapy augmented by either DCS or placebo. D-cycloserine is an FDA-approved antibiotic medication that has been shown to enhance extinction learning in several studies. The investigators' proof-of-concept work has found that a single session of DCS-augmented behavior therapy reduced the severity of tics targeted in treatment on the Hopkins Motor/Vocal Tic Scale (HM/VTS) compared to placebo-augmented behavior therapy. This highlights the exciting potential of combining DCS with behavior therapy to improve reductions in tic severity. However, prior to a large-scale clinical trial, it is essential to determine the feasibility and efficacy of augmenting behavior therapy with DCS over multiple treatment sessions.
Detailed Description
Tourette's Disorder and Persistent Tic Disorders (collectively referred to as TD) are characterized by the presence of motor and/or vocal tics. For many youth with TD, the severity of tics results in considerable functional impairment and a poor quality of life. While historically managed with psychotropic medications, behavior therapy has demonstrated efficacy for reducing the severity of tics. However, only 50% of youth with TD exhibit a positive treatment response to behavior therapy, and many treatment responders continue to experience bothersome tics. Thus, there is a need to investigate strategies to improve therapeutic outcomes from behavior therapy for youth with TD. This pilot study aims evaluate the feasibility and initial efficacy of behavior therapy augmented by d-cycloserine (DCS) compared to behavior therapy augmented by placebo. After an initial assessment to determine eligibility, youth with TD will be randomly assigned to receive four sessions of behavior therapy augmented by either DCS or placebo. D-cycloserine is an FDA-approved antibiotic medication that has been shown to enhance extinction learning in several studies. The investigators' proof-of-concept work has found that a single session of DCS-augmented behavior therapy reduced the severity of tics targeted in treatment on the Hopkins Motor/Vocal Tic Scale (HM/VTS) compared to placebo-augmented behavior therapy. This highlights the exciting potential of combining DCS with behavior therapy to improve reductions in tic severity. However, prior to a large-scale clinical trial, it is essential to determine the feasibility and efficacy of augmenting behavior therapy with DCS over multiple treatment sessions.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Tourette Syndrome
Keywords
habit reversal training, Comprehensive Behavioral Intervention for Tics, d-cycloserine, behavior therapy

7. Study Design

Primary Purpose
Treatment
Study Phase
Early Phase 1
Interventional Study Model
Parallel Assignment
Model Description
This trial will evaluate the feasibility and initial efficacy of behavior therapy augmented with d-cycloserine (DCS) compared to behavior therapy augmented with placebo.
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Masking Description
Participants, therapists, investigators, and outcome assessors will all be masked to treatment assignment. Only the study coordinator will be aware of random assignment to treatment condition.
Allocation
Randomized
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Behavior Therapy + DCS
Arm Type
Experimental
Arm Description
Youth with TD will receive four, 2-hour long sessions of evidence-based behavior therapy delivered in an intensive format. Participants will arrive an hour early for each session to take the d-cycloserine pill prior to starting each session of behavior therapy. Participants, therapists, and outcome assessors will be masked to pill condition.
Arm Title
Behavior Therapy + Placebo
Arm Type
Active Comparator
Arm Description
Youth with TD will receive four, 2-hour long sessions of evidence-based behavior therapy delivered in an intensive format. Participants will arrive an hour early for each session to take the placebo pill prior to starting each session of behavior therapy. Participants, therapists, and outcome assessors will be masked to pill condition.
Intervention Type
Drug
Intervention Name(s)
d-cycloserine
Intervention Description
D-cycloserine is an FDA-approved antibiotic medication that has been shown to enhance extinction learning in several studies. It will be paired with 4 sessions of behavior therapy.
Intervention Type
Drug
Intervention Name(s)
Placebo pill
Intervention Description
A pill placebo serves as an active comparator. It will be paired with 4 sessions of behavior therapy.
Intervention Type
Behavioral
Intervention Name(s)
Behavior Therapy
Intervention Description
All participants will receive 4 sessions of behavior therapy for tics (e.g., habit reversal training, comprehensive behavioral intervention for tics).
Primary Outcome Measure Information:
Title
Change in Hopkins Motor/Vocal Tic Scale (HM/VTS) score
Description
Participants can nominate up to five motor and five vocal tics participants 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 (baseline) and 1 Week post-treatment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
8 Years
Maximum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 8-17 years Meet Diagnostic and Statistical Manual of Mental Disorders (DSM)-5 criteria for Tourette's Disorder, Persistent Motor Tic Disorder, or Persistent Vocal Tic Disorder Have moderate tic severity or greater as evidenced by a Yale Global Tic Severity Scale (YGTSS) total score greater than 13 (>9 for children with motor or vocal tics only) Be fluent in English Exclusion Criteria: Current diagnosis of substance abuse/dependence Lifetime diagnosis of autism spectrum disorder, mania or psychosis History of a seizure disorder, kidney disease, or liver disease Four or more previous sessions of behavior therapy
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Joseph McGuire, PhD
Organizational Affiliation
Johns Hopkins University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Johns Hopkins University School of Medicine
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21205
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
This is a pilot study intended to demonstrate feasibility and test preliminary efficacy. The investigators do not plan to share individual participant data.

Learn more about this trial

D-cycloserine Augmented Treatment for Youth With Tic Disorders

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