Buspirone for Anxiety in Autistic Youth

NCT07439042 | Recruiting Phase 4 DMC

• 1 other identifier: 2025P003437
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Mean 16-Week Change in Pediatric Anxiety Rating Scale (PARS) 5-Item Total Score

  The PARS, a clinician-administered measure of child anxiety symptom severity based on both patient and parent-report will be the primary outcome measure. It has demonstrated inter-rater and test-retest reliability, and has previously been used by our group as the primary outcome measure in a RCT of mirtazapine for anxiety in youth with ASD, demonstrating sensitivity to change. The 5-item PARS score will be the primary outcome measure for this trial. Scaled score ranges from 0-25 with higher scores indicating more severe anxiety symptoms.

  Baseline, Week 4, Week 8, Week 2, Week 16; Change from Baseline to Week 16 reported

Secondary Outcomes (3)

• Proportion of Participants who Responded to Treatment at 16 Weeks According to the Improvement Item of the Clinical Global Impression-Improvement (CGI-I) (Response Defined as CGI-I = 1 or 2)

  Week 4, Week 8, Week 12, Week 16. Week 16 score reported.

• Mean 16-Week Change in Clinical Global Impression Severity Subscale (CGI-S)

  Baseline, Week 4, Week 8, Week 12, Week 16. Change from Baseline to Week 16 reported.

• Mean 16-Week Change in Parent-Rated Anxiety Scale for Autism Spectrum Disorder (PRAS-ASD) Score

  Baseline, Week 8, Week 16. Change from Baseline to Week 16 reported.

Other Outcomes (18)

• Mean 16-Week Change in Aberrant Behavior Checklist (ABC-2) Irritability Subscale Score

  Baseline, Week 8, Week 16; Change from Baseline to Week 16 reported

• Mean 16-Week Change in Aberrant Behavior Checklist (ABC-2) Lethargy/Social Withdrawal Subscale Score

  Baseline, Week 8, Week 16; Change from Baseline to Week 16 reported

• Mean 16-Week Change in Aberrant Behavior Checklist (ABC-2) Stereotypic Behavior Subscale Score

  Baseline, Week 8, Week 16; Change from Baseline to Week 16 reported

Study Arms (2)

Buspirone

ACTIVE COMPARATOR

Drug: buspirone

Placebo

PLACEBO COMPARATOR

Drug: Placebo

Interventions

buspirone DRUG

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

Buspirone

Placebo DRUG

Matching placebo capsules/liquid formulation will be prepared.

Placebo

Eligibility Criteria

• Age: 7 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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
• 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
• Aberrant Behavior Checklist Irritability subscale score (ABC-I) ≥18
• Pregnancy or sexual activity without the use of an acceptable form of birth control in females of childbearing age
• 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

Sponsors & Collaborators

• Massachusetts General Hospital: lead

Study Sites (1)

Lurie Center

Lexington, Massachusetts, 02421, United States

RECRUITING

MeSH Terms

Conditions

Anxiety Disorders; Autism Spectrum Disorder; Autistic Disorder

Interventions

Buspirone

Condition Hierarchy (Ancestors)

Mental Disorders; Child Development Disorders, Pervasive; Neurodevelopmental Disorders

Intervention Hierarchy (Ancestors)

Spiro Compounds; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Piperazines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Pyrimidines; Polycyclic Compounds

Central Study Contacts

Robyn P. Thom, MD

CONTACT

781-860-1711; luriecenterresearch@mgb.org

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: February 13, 2026
• First Posted: February 27, 2026
• Study Start: September 1, 2026
• Primary Completion (Estimated): February 1, 2029
• Study Completion (Estimated): June 1, 2029
• Last Updated: September 17, 2026

Record last verified: 2026-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)