An Open-Label Trial of Buspirone for the Treatment of Anxiety in Youth With Autism Spectrum Disorders

Mass General Brigham

Status

Completed

Conditions

Anxiety

Autism Spectrum Disorders

Treatments

Drug: Buspirone

Study type

Interventional

Funder types

Other

Identifiers

NCT01850355

2013-P-000661

Details and patient eligibility

About

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 hypothesis for a larger randomized controlled clinical trials with explicit hypotheses and sufficient statistical power.

Enrollment

9 patients

Sex

All

Ages

6 to 17 years old

Volunteers

No Healthy Volunteers

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 ≥13 on the Pediatric Anxiety Rating Scale (PARS)
Participants with a score of ≥60 or more on the Anxiety/Depression subscale of 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 trial treatment and if they are stable, provided the medication is not listed in the Concomitant Medications section of the protocol.
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

I.Q. < 70
DSM-IV-TR PDD diagnoses 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
Current diagnosis of schizophrenia
History of substance use (except nicotine or caffeine) within past 3 months or urine drug screen positive for substances of abuse
Current treatment with medication with primary central nervous system activity (as specified in the Concomitant Medication section of the protocol)
A non-responder or history of intolerance to buspirone, after treatment at an adequate dose and duration as determined by the clinician
Subjects currently taking monoamine oxidase inhibitors (MAOI) and/or CYP3A4 inducers or inhibitors including nefazodone, diltiazem, verapamil, erythromaycin, itraconazole, or rifampin.