Augmentation of Brief Habit Reversal Training With D-cycloserine or Placebo

NCT02582515 | Completed Results

• 1 other identifier: UCLA_DCS+HRT
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

Expert reviews and practice parameter papers recommend behavior therapy as a first-line intervention for youth with chronic tic disorders (CTDs) with mild-to-moderate tic severity. Although behavior therapies like the Comprehensive Behavioral Intervention for Tics (CBIT) are efficacious in reducing tic symptom severity, only 50% of individuals exhibit a positive treatment response. Thus, there is a clear need to identify strategies to improve treatment response and/or accelerate therapeutic gains . The primary ingredient of CBIT is habit reversal training (HRT), which utilizes both extinction and associative learning. Psychosocial treatments relying on these learning mechanisms have demonstrated an enhanced and/or expedited therapeutic benefit when augmented with d-cycloserine (DCS). This feasibility study will examine the incremental efficacy of HRT+DCS over HRT+placebo for tics targeted with HRT. Eligibility criteria will parallel the child CBIT trial for generalizability and comparability, with the addition of DCS contraindications as exclusionary criteria. Parents and youth will complete a battery of clinical assessments to ascertain tic symptoms severity and co-occurring psychiatric conditions. Afterwards, participants will be randomly assigned to receive either HRT+DCS or HRT+placebo. Instead of a full course of HRT (8 sessions over 10 weeks), a more efficient Quick-Win/Fast-Fail trial design will be used that includes a truncated HRT protocol to provide results in a more timely fashion. As a result of this trial design, the primary outcome of this study will focus on the reduction of bothersome tic severity for those targeted in treatment rather than global severity reductions.

Conditions

Tourette Disorder; Chronic Tic Disorder

Keywords

d-cycloserine; comprehensive behavioral intervention for tics; habit reversal training

Outcome Measures

Primary Outcomes (1)

• Hopkins Motor/Vocal Tic Scale (HM/VTS)

  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

  Pre-treatment, One Week post-treatment

Study Arms (2)

D-cycloserine + Habit Reversal Training

EXPERIMENTAL

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.

Drug: D-cycloserine

Placebo + Habit Reversal Training

PLACEBO COMPARATOR

Participants randomly assigned to the placebo condition will receive a single dose of placebo immediately prior to a single session of habit reversal training.

Drug: Placebo

Interventions

D-cycloserine DRUG

Also known as: Habit Reversal Training

D-cycloserine + Habit Reversal Training

Placebo DRUG

Also known as: Habit Reversal Training

Placebo + Habit Reversal Training

Eligibility Criteria

• Age: 8 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• ages 8 years to 17 years (inclusive);
• meet diagnostic criteria for either Tourette Disorder or a Persistent Tic Disorder;
• moderate tic severity or greater as evidenced by a Yale Global Tic Severity Scale (Leckman, Riddle, Hardin, \& Ort, 1989) total score greater than 13 (\>9 for children with motor or vocal tics only);
• be fluent in English;
• be medication free or on a stable dose of a non-antipsychotic medication for 6 weeks with no planned changes.

You may not qualify if:

• pregnant or breast feeding;
• an unstable medical condition (e.g., a seizure disorder, kidney or liver disease);
• current diagnosis of substance abuse/dependence;
• lifetime diagnosis of schizophrenia, autism spectrum disorder, bipolar disorder, or psychosis;
• evidence of a seizure disorder, kidney or liver disease, pregnant and/or breast feeding;
• four or more previous sessions of HRT; or
• currently taking an antipsychotic medication.

Sponsors & Collaborators

• University of California, Los Angeles: lead

Study Sites (1)

UCLA Semel Institute for Neuroscience and Human Behavior

Los Angeles, California, 90024, United States

Location

MeSH Terms

Conditions

Tourette Syndrome; Tic Disorders

Interventions

Cycloserine

Condition Hierarchy (Ancestors)

Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Heredodegenerative Disorders, Nervous System; Neurodegenerative Diseases; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Neurodevelopmental Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Isoxazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Oxazolidinones; Oxazoles; Serine; Amino Acids, Neutral; Amino Acids; Amino Acids, Peptides, and Proteins

Results Point of Contact

• Title: Assistant Professor
• Organization: Johns Hopkins University School of Medicine

jfmcguire@jhmi.edu

443-287-5143

Study Officials

• Joseph F McGuire, Ph.D.

  University of California, Los Angeles

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Postdoctoral Fellow and Clinical Instructor

Study Record Dates

• First Submitted: October 16, 2015
• First Posted: October 21, 2015
• Study Start: October 1, 2015
• Primary Completion: August 1, 2017
• Study Completion: August 1, 2017
• Last Updated: April 25, 2019
• Results First Posted: April 25, 2019

Record last verified: 2019-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)