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

Who is this study for? Patients with Tourette Syndrome
What treatments are being studied? Behavior Therapy
Status: Recruiting
Location: See location...
Intervention Type: Drug, Behavioral
Study Type: Interventional
Study Phase: Early Phase 1
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 8
Maximum Age: 17
Healthy Volunteers: No
View:

• 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

Locations
United States
Maryland
Johns Hopkins University School of Medicine
Recruiting
Baltimore
Contact Information
Primary
Joseph McGuire, PhD
jfmcguire@jhmi.edu
443-287-7157
Time Frame
Start Date: December 15, 2022
Estimated Completion Date: September 2023
Participants
Target number of participants: 10
Treatments
Experimental: Behavior Therapy + DCS
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.
Active Comparator: Behavior Therapy + Placebo
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.
Authors
Joseph McGuire
Sponsors
Leads: Johns Hopkins University

This content was sourced from clinicaltrials.gov

Similar Clinical Trials