NCT07439042 Buspirone for Anxiety in Autistic Youth
| NCT ID | NCT07439042 |
| Status | Recruiting |
| Phase | Phase 4 |
| Sponsor | Massachusetts General Hospital |
| Condition | Anxiety |
| Study Type | INTERVENTIONAL |
| Enrollment | 20 participants |
| Start Date | 2026-09 |
| Primary Completion | 2029-02 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 4 studies follow an already-approved treatment in real-world conditions to monitor long-term safety and effectiveness.
This trial targets 20 participants in total. It began in 2026-09 with a primary completion date of 2029-02.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
Eligibility Criteria
Inclusion Criteria: 1. Age 7-17 years 2. 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) 3. 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 4. IQ ≥50 based on Stanford Binet, 5th Edition Abbreviated IQ test or the Kaufman Brief Intelligence Test, 2nd Edition (KBIT-2) 5. Stable medications for ≥30 days 6. English speaking 7. Ability to swallow buspirone capsules or liquid suspension Exclusion Criteria: 1. Known diagnosis of a genetic syndrome associated with ASD (e.g. Fragile X syndrome, Angelman syndrome) based on parent report 2. Known cardiac arrythmia based on parent report 3. 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 4. Any past or present conditions that would make treatment with buspirone unsafe 5. Current use of any of the following psychotropic medications: SSRIs, SNRIs, mirtazapine, benzodiazepines, tricyclic antidepressants, monoamine oxidase inhibitors, mood stabilizers, or antipsychotics 6. Previous adequate trial of buspirone (≥20 mg/day for at least 4 weeks) or significant adverse effects 7. Aberrant Behavior Checklist Irritability subscale score (ABC-I) ≥18 8. Pregnancy or sexual activity without the use of an acceptable form of birth control in females of childbearing age 9. Acutely unstable medical/psychiatric condition (e.g. self-injury, suicidality) that would preclude study participation in the opinion of the PI 10. Inability to tolerate Bittium Faros device in the opinion of the parent or a known allergy to adhesives
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07439042 clinical trial?
This trial is open to participants of all sexes, aged 7 Years or older, up to 17 Years, studying Anxiety. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07439042 trial and what does that mean for participants?
Phase 4 studies are conducted after a treatment has been approved. They monitor long-term safety and real-world effectiveness in a broader patient population.
Is NCT07439042 currently recruiting?
Yes, NCT07439042 is actively recruiting participants. Contact the research team at luriecenterresearch@mgb.org for enrollment information.
Where is the NCT07439042 trial being conducted?
This trial is being conducted at Lexington, United States.
Who is sponsoring the NCT07439042 clinical trial?
NCT07439042 is sponsored by Massachusetts General Hospital. The trial plans to enroll 20 participants.
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