Buspirone for Anxiety in Autism
Trial Summary
What is the purpose of this trial?
This trial is testing buspirone, a medication that helps calm the brain, to see if it can reduce anxiety in children and teenagers with autism. The study will last for a few months and aims to check if the medication is safe and effective for this group. Buspirone is used to treat generalized anxiety disorder in children and may be useful in developmental disorders in which brain serotonin synthesis is altered.
Will I have to stop taking my current medications?
You can continue taking your current medications if you've been on a stable dose for at least 4 weeks, unless they are listed in the protocol's Concomitant Medications section. You cannot take certain medications like MAOIs or CYP3A4 inducers or inhibitors.
What data supports the effectiveness of the drug buspirone for anxiety in autism?
Is buspirone safe for use in humans?
How is the drug buspirone unique for treating anxiety in autism?
Buspirone is unique because it is a non-benzodiazepine drug that works by partially activating serotonin receptors, which can help reduce anxiety without causing sedation or dependency. This makes it different from traditional anxiety medications, and it may be particularly useful for people who need a gradual onset of relief and are concerned about the side effects of other drugs.110111213
Research Team
Atilla Ceranoglu, MD
Principal Investigator
Massachusetts General Hospital
Eligibility Criteria
This trial is for children and teens aged 6-17 with autism spectrum disorders who also experience anxiety, as indicated by a specific score on the CBCL Anxiety/Depression subscale. They must meet DSM-5 criteria for ASD and can be on stable psychotropic medications not listed in the protocol's Concomitant Medications section. Those with buspirone intolerance, seizure disorders, certain ECG abnormalities, or unstable psychiatric conditions cannot participate.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive buspirone tablets twice daily, titrated to a maximum daily dose of 60mg for 8 weeks
Follow-up
Participants are monitored for safety and effectiveness after treatment
Treatment Details
Interventions
- Buspirone
Buspirone is already approved in United States, European Union, Canada for the following indications:
- Generalized anxiety disorder
- Generalized anxiety disorder
- Generalized anxiety disorder
Find a Clinic Near You
Who Is Running the Clinical Trial?
Massachusetts General Hospital
Lead Sponsor