NCT07439042RecruitingPhase 4
Buspirone for Anxiety in Autistic Youth
A Randomized Controlled Trial of Buspirone for Anxiety in Autistic Youth
Source: ClinicalTrials.gov · Last updated 17 Sept 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 4
- Study type
- Interventional
- Enrollment
- 20 (estimated)
- First submitted
- 13 Feb 2026
- Start date
- 1 Sept 2026
- Primary completion date
- 28 Feb 2029
- Lead sponsor
- Massachusetts General Hospital
- Diseases
- Autism
- NCT number
- NCT07439042
What you commit to
- Study type: Interventional · Phase 4
- Planned participants: 20
- From 1 Sept 2026 to the primary completion date, 28 Feb 2029
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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
Other illness
- 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
Age
- Pregnancy or sexual activity without the use of an acceptable form of birth control in females of childbearing age
Other
- Aberrant Behavior Checklist Irritability subscale score (ABC-I) ≥18
Who the study is looking for
- 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
Age in the registry: 7 years to 17 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Lurie Center Coordinator of this site? Confirm its status | Lexington | United States | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.