Could a common anxiety drug help autistic youth? new trial aims to find out.
NCT ID NCT07439042
First seen Jun 27, 2026 · Last updated Sep 18, 2026 · Updated 3 times
Summary
This study tests whether buspirone, a medication used for anxiety, is safe and effective for autistic youth aged 7 to 17 who also have anxiety disorders. Researchers will measure changes in anxiety symptoms over 16 weeks. The goal is to see if this drug can ease anxiety in this specific group.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
-
Phase 4
Runs after approval, following long-term safety and how well the treatment works in everyday use.
- Participants
-
About 20 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
-
Sep 2026
An estimate. Start dates often move.
- Expected to finish
-
Jun 2029
An estimate. End dates often move.
- Lead sponsor
-
Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
-
7 to 17 years
- Sex
-
Anyone
- Healthy volunteers
-
Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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
Get updates
Get notified about this study
Sign up to get updates when this study changes or when new studies for Anxiety are added.
Genom att skicka in godkänner du våra Användarvillkor
Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
-
The study's own enquiry address
This study publishes an address for enquiries. See it below .
-
The places running it
1 site. The list below names each one and where it is.
-
The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
-
A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Show contact details
Enter your email to view the contact information for this study.
Genom att skicka in godkänner du våra Användarvillkor
Study contacts
-
Contact
Email: •••••@•••••
Locations
-
Lurie Center
RECRUITINGLexington, Massachusetts, 02421, United States
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Can wireless monitors make ER vitals easier for autistic children?
- Can video games calm anxious teens?
- Can a group program teach teens to cope before therapy starts?
- Why do some children with autism struggle with balance?
- Could a Patient's playlist take the sting out of nerve testing?
- Three spanish group sessions put a neuroscience twist on anxiety therapy