Recruiting

Buspirone

Sponsor:

Massachusetts General Hospital

Code:

NCT07439042

Conditions

Anxiety

Autism Spectrum Disorder

Eligibility Criteria

Sex: All

Age: 7 - 17

Healthy Volunteers: Not accepted

Interventions

buspirone

Placebo

Study Details

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.

Conditions

Anxiety

Autism Spectrum Disorder

Study ID

NCT07439042

Start date

Sep, 2026

Status verified date

Sep, 2026

Completion date

Jun, 2029

Anticipated

Primary completion date

Feb, 2029

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 7 - 17

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

20 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

active comparator: Buspirone

placebo comparator: Placebo

Interventions

buspirone

Buspirone, an anxiety medication that is FDA approved for generalized anxiety disorder in adults, will be the active comparator for this trial.

Placebo

Matching placebo capsules/liquid formulation will be prepared.

Primary outcome measure

  • Mean 16-Week Change in Pediatric Anxiety Rating Scale (PARS) 5-Item Total Score [ Time Frame: Baseline, Week 4, Week 8, Week 2, Week 16; Change from Baseline to Week 16 reported ]

Central Contacts and Locations

Central contacts

Locations

Lurie Center

Recruiting

Lexington, Massachusetts, United States, 02421

More Information

Sponsor

Massachusetts General Hospital

Last update posted

Sep 17, 2026

Last verified

Sep, 2026

Keywords

  • buspirone
  • anxiety
  • autism
  • autism spectrum disorder
  • randomized controlled trial

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-18. This information was provided to ClinicalTrials.gov by Massachusetts General Hospital on 2026-09-17.