Clinical trial

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

Name

2011-P-000703

Description

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.

Trial arms

Trial start

2011-11-01

Estimated PCD

2013-07-01

Trial end

2013-07-01

Status

Withdrawn

Phase

Early phase I

Treatment

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.

Arms:

Buspirone

Other names:

Buspar

Placebo

Arms:

Placebo

Primary endpoint

Reduction in Pediatric Anxiety Rating Scale (PARS) Score

baseline to 8 weeks

Clinical Global Impression-Anxiety (CGI-Anxiety) Improvement Score

baseline to 8 weeks

Eligibility criteria

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.

Protocol

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE2'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}}, 'enrollmentInfo': {'count': 0, 'type': 'ACTUAL'}}

Updated at

2024-06-28

1 organization

1 product

1 drug

1 indication

Organization

Massachusetts General Hospital

Product

Buspirone

Indication

Autism Spectrum Disorder

Drug

Varlilumab