Testing buspirone for anxiety in autistic children and teens
Tests whether buspirone helps anxiety in autistic youth aged 7 to 17.
Plain-language title generated from the registry record
Registry title: Buspirone for Anxiety in Autistic Youth
Key facts
- Where
- Lexington, United StatesSee the site
- Phase
- Phase 4
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 7 and 17 years old?
Source: NCT07439042, who can take part
Where in United States
- Lurie CenterLexington, United StatesTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Massachusetts General Hospital
- Trial code
- NCT07439042
- Record updated
- 17 September 2026
- Original description
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.Read full original descriptionShow less
A Randomized Controlled Trial of Buspirone for Anxiety in Autistic Youth
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.
Inclusion: 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.
Exclusion: 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; 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; 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; Pregnancy or sexual activity without the use of an acceptable form of birth control in females of childbearing age; Aberrant Behavior Checklist Irritability subscale score (ABC-I) ≥18.