A Pilot Study of Buspirone for the Treatment of Anxiety in Youth with Autism Spectrum Disorders

Mass General Brigham

Status and phase

Withdrawn

Phase 2

Conditions

Autism Spectrum Disorder

Anxiety

Treatments

Drug: Buspirone

Study type

Interventional

Funder types

Other

Identifiers

NCT03432065

2017-P-002731

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 hypotheses for a larger randomized-controlled trial with explicit hypotheses and sufficient statistical power.

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
DSM-5 ASD diagnostic criteria as established by clinical diagnostic interview
Participants with a score of ≥60 or more on the Anxiety/Depression subscale of CBCL
Subjects can be taking psychotropic medications 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, provided the medication is not listed in the Concomitant Medications section of the protocol.

Exclusion criteria

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 or bipolar disorder
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.