Buspirone for Anxiety in Autistic Youth

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This randomized, double-blind, placebo-controlled trial will enroll youths aged 7–17 with autism and moderate anxiety. Over 16 weeks, participants a flexibly-dosed buspirone regimen or placebo will be compared, with dose adjustments during weeks 1–12 and a stable dose through week 16. Safety and tolerability will be monitored at each visit, and standardized anxiety measures will be collected at weeks 4, 8, 12, and 16. Eligible participants must have ASD confirmed by DSM-5 and SCQ, with additional anxiety disorder criteria, adequate IQ, and stable medications. The study is led by Massachusetts General Hospital with a participation site at Lurie Center in Lexington, MA.

Why it matters

Who can join: the full rules

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

Where it's running

• Lurie Center
  Lexington, Massachusetts, United States Recruiting

Study contacts

• Study coordinator: Robyn P. Thom, MD
• Email: luriecenterresearch@mgb.org
• Phone: 781-860-1711

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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• Marijuana-derived compound for anxiety in autistic adults

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• Comparing Sertraline and Placebo for Treating Anxiety in Children with Neurodevelopmental Disorders

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.