D-cycloserine Augmented Treatment for Youth With Tic Disorders

Tourette Syndrome Clinical Trial

Official title:

D-cycloserine Augmented Treatment: Enhancing Extinction Learning in Youth With Tic Disorders

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT04357951
• Other study ID #: IRB00210948
• Status: Withdrawn
• Phase: Early Phase 1
• Start date: April 15, 2023
• Est. completion date: September 2024

Study information

• Verified date: April 2023
• Source: Johns Hopkins University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: September 2024
• Est. primary completion date: March 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 8 Years to 17 Years

Eligibility

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

Related Conditions & MeSH terms

• Tic Disorders
• Tics
• Tourette Syndrome

Intervention

Drug:
• d-cycloserine
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.
• Placebo pill
A pill placebo serves as an active comparator. It will be paired with 4 sessions of behavior therapy.

Behavioral:
• Behavior Therapy
All participants will receive 4 sessions of behavior therapy for tics (e.g., habit reversal training, comprehensive behavioral intervention for tics).

Locations

Country	Name	City	State
United States	Johns Hopkins University School of Medicine	Baltimore	Maryland

Sponsors (1)

Lead Sponsor	Collaborator
Johns Hopkins University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Pre-treatment (baseline) and 1 Week post-treatment