Double-blind Trial of Buspirone for the Treatment of Anxiety in Youth With Autism Spectrum Disorders

The main objective of this exploratory 8 week pilot study is to evaluate the safety and efficacy of buspirone for the treatment of anxiety in youth (ages 6-17 years) with autism spectrum disorders. The study results will be used to generate hypotheses for a larger randomized controlled clinical trial with explicit hypotheses and sufficient statistical power.

Study Overview

• Status: Withdrawn
• Conditions: Autism Spectrum Disorder (ASD)
• Intervention / Treatment: Drug: Buspirone; Drug: Placebo

• Study Type: Interventional
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • Massachusetts
    • Boston, Massachusetts, United States, 02114
      • Massachusetts General Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 4 years to 15 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Male or female participants between 6 and 17 years of age.
• Fulfills diagnosis of autism spectrum disorders by meeting DSM-IV-TR PDD diagnostic criteria of autistic disorder, Asperger's disorder, or PDD-NOS as established by clinical diagnostic interview.
• Participants with a score of ≥60 on the Anxiety/Depression subscale of Child Behavior Checklist (CBCL) and CGI-Anxiety severity of ≥4.
• Subjects can be on psychotropic drugs if they have been on the medication for at least 4 weeks prior to initiating study treatment and if they are on a stable dose.
• Subjects with disruptive behavior disorders, mood, or psychosis will be allowed to participate in the study provided they do not meet any exclusionary criteria.

Exclusion Criteria:

• Mental retardation (I.Q. <70)
• DSM-IV-TR PDD diagnosis of Rett's disorder, and childhood disintegrative disorder.
• History of active seizure disorder (EEG suggestive of seizure activity and/or history of seizure in last 1 month).
• Subjects with a medical condition or treatment that will either jeopardize subject safety or affect the scientific merit of the study, including: pregnant or nursing females, organic brain disorders, uncorrected hypothyroidism or hyperthyroidism, clinically significant abnormalities on ECG (e.g. QT prolongation, arrhythmia), history of renal or hepatic impairment.
• Clinically unstable psychiatric conditions or judged to be at serious suicidal risk.
• History of substance abuse (except nicotine of caffeine) within past 3 months or urine drug screen positive for substances of abuse.
• Any other concomitant medication with primary central nervous system activity other than stable regimens for >2 weeks.
• A non-responder or history of intolerance to buspirone, after treatment at an adequate dose and duration as determined by the clinician.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo	Drug: Placebo; Children with Autism Spectrum Disorders will receive buspirone or matched placebo. Buspirone will be titrated to the maximum daily dose during the first four weeks of the trial (dose titration phase). Week 4 onwards subjects will be maintained on maximum achieved dose till the end of the trial (dose maintenance phase). During the titration phase total dose of buspirone will be increased at each visit by 5mg and on the 4th day after each visit by 5mg.
Active Comparator: Buspirone	Drug: Buspirone; Children with Autism Spectrum Disorders will receive buspirone or matched placebo. Buspirone will be titrated to the maximum daily dose during the first four weeks of the trial (dose titration phase). Week 4 onwards subjects will be maintained on maximum achieved dose till the end of the trial (dose maintenance phase). During the titration phase total dose of buspirone will be increased at each visit by 5mg and on the 4th day after each visit by 5mg.; Other Names: Buspar

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Reduction in Pediatric Anxiety Rating Scale (PARS) Score	Primary outcome measure of efficacy will be assessed by reduction in anxiety symptom severity as measured by change from baseline. Responders are defined as ≥30% reduction in the Pediatric Anxiety Rating Scale (PARS).	baseline to 8 weeks
Clinical Global Impression-Anxiety (CGI-Anxiety) Improvement Score	Primary outcome measure of efficacy will be assessed by reduction in anxiety symptom severity as measured by Clinical Global Impression-Anxiety (CGI-Anxiety). Responders are defined as a score of ≤2 on the improvement subscale (i.e., "much" or "very much improved").	baseline to 8 weeks

Collaborators and Investigators

• Sponsor: Massachusetts General Hospital
• Investigators: Principal Investigator: Gagan Joshi, M.D., Massachusetts General Hospital

Study record dates

Study Major Dates

• Study Start: November 1, 2011
• Primary Completion (Actual): July 1, 2013
• Study Completion (Actual): July 1, 2013

Study Registration Dates

• First Submitted: July 14, 2011
• First Submitted That Met QC Criteria: July 14, 2011
• First Posted (Estimate): July 18, 2011

Study Record Updates

• Last Update Posted (Actual): July 9, 2021
• Last Update Submitted That Met QC Criteria: July 8, 2021
• Last Verified: July 1, 2021

More Information

Terms related to this study

• Keywords: Adolescents; Anxiety; Children; Autism Spectrum Disorders; Pervasive Developmental Disorders; Buspirone; Buspar
• Additional Relevant MeSH Terms: Mental Disorders; Pathologic Processes; Neurodevelopmental Disorders; Disease; Autistic Disorder; Autism Spectrum Disorder; Child Development Disorders, Pervasive; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Central Nervous System Depressants; Tranquilizing Agents; Psychotropic Drugs; Serotonin Agents; Serotonin Receptor Agonists; Anti-Anxiety Agents; Buspirone
• Other Study ID Numbers: 2011-P-000703