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Not yet recruiting NCT07439042

Buspirone for Anxiety in Autistic Youth

Phase IV Interventional Anxiety Autism Spectrum Disorder

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: buspirone, Placebo.
Who it may be relevant to
Registry conditions: Anxiety, Autism Spectrum Disorder. Basic parameters: 7 years — 17 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

A Randomized Controlled Trial of Buspirone for Anxiety in Autistic Youth

Overview

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.

Detailed description

After being informed about the study and potential risks, all patients or their legal guardians giving written informed consent will be screened for study eligibility. Patients who meet the eligibility requirements will participate in a 16-week, flexibly-dosed, randomized controlled trial of buspirone versus placebo. The dose of buspirone will be adjusted over the first 12 weeks of the study and a stable dose will be maintained for the final four weeks of the trial. Adverse effects will be reviewed at each visit and standardized measures of anxiety will be conducted at weeks 4, 8, 12, and 16.

Interventions

  • Drug buspirone
    Buspirone, an anxiety medication that is FDA approved for generalized anxiety disorder in adults, will be the active comparator for this trial.
  • Drug Placebo
    Matching placebo capsules/liquid formulation will be prepared.

Primary outcome measures

  • 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]
Secondary outcome measures (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) [Time frame: Week 4, Week 8, Week 12, Week 16. Week 16 score reported.]
  • Mean 16-Week Change in Clinical Global Impression Severity Subscale (CGI-S) [Time frame: 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 [Time frame: Baseline, Week 8, Week 16. Change from Baseline to Week 16 reported.]

Eligibility criteria

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Quadruple blind
Primary purpose
Treatment

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT07439042 · 2025P003437

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗