RecruitingPhase 4NCT07439042

Buspirone for Anxiety in Autistic Youth

A Randomized Controlled Trial of Buspirone for Anxiety in Autistic Youth

Sponsor

Massachusetts General Hospital

Enrollment

20 participants

Start Date

Sep 1, 2026

Study Type

INTERVENTIONAL

Conditions

The purpose of the study is to do a preliminary trial to determine if buspirone is effective, safe, and tolerable in autistic youth with anxiety.

Min Age: 7 YearsMax Age: 17 Years

Age 7-17 years
Diagnosis of Autism Spectrum Disorder (ASD) confirmed by the study clinician using the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) criteria and Social Communication Questionnaire (SCQ)
Diagnosis of social phobia, separation anxiety disorder, or generalized anxiety disorder of at least moderate severity based on the Anxiety and Related Disorders Interview Schedule (ADIS), 5-item Pediatric Anxiety Rating Scale (PARS) score ≥10, and Clinical Global Impression Severity subscale (CGI-S) ≥4
IQ ≥50 based on Stanford Binet, 5th Edition Abbreviated IQ test or the Kaufman Brief Intelligence Test, 2nd Edition (KBIT-2)
Stable medications for ≥30 days
English speaking
Ability to swallow buspirone capsules or liquid suspension

Known diagnosis of a genetic syndrome associated with ASD (e.g. Fragile X syndrome, Angelman syndrome) based on parent report
Known cardiac arrythmia based on parent report
Current primary diagnosis of bipolar disorder, psychosis, substance use disorder, posttraumatic stress disorder, eating disorder, or major depressive disorder in the opinion of the PI
Any past or present conditions that would make treatment with buspirone unsafe
Current use of any of the following psychotropic medications: SSRIs, SNRIs, mirtazapine, benzodiazepines, tricyclic antidepressants, monoamine oxidase inhibitors, mood stabilizers, or antipsychotics
Previous adequate trial of buspirone (≥20 mg/day for at least 4 weeks) or significant adverse effects
Aberrant Behavior Checklist Irritability subscale score (ABC-I) ≥18
Pregnancy or sexual activity without the use of an acceptable form of birth control in females of childbearing age
Acutely unstable medical/psychiatric condition (e.g. self-injury, suicidality) that would preclude study participation in the opinion of the PI
Inability to tolerate Bittium Faros device in the opinion of the parent or a known allergy to adhesives