Buspirone for Anxiety in Autistic Youth
Starting soon · Phase 4 · Has a placebo group
Conditions studied: Anxiety, Autism Spectrum Disorder
In brief
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.
Key facts
- Study ID
- NCT07439042
- Run by
- Massachusetts General Hospital
- People needed
- 20
- Starts
- 2026-08-01
- Expected to finish
- 2029-06-01
- Last updated by the study team
- 2026-02-27
Who can join
Age: 7 and older, up to 17. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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
Full record on ClinicalTrials.gov
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