Buspirone for Anxiety in Autistic Youth

Sponsor
Massachusetts General Hospital
Study ID
NCT07439042
Phase
PHASE4
Status
Not Yet Recruiting

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Conditions

Eligibility Criteria

Sex
ALL
Age
7 Years - 17 Years
Healthy Volunteers
Not accepted

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.
  • Placebo — DRUG
    Matching placebo capsules/liquid formulation will be prepared.

Study Details

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.

Key Dates

First listed
Feb 27, 2026
Start date
Aug 31, 2026
Status verified
Feb 2026
Primary completion
Feb 28, 2029
Completion
Jun 30, 2029

Study Design

Enrollment
20 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: Buspirone
  • Placebo Comparator: Placebo

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

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