Status:
WITHDRAWN
A Pilot Study of Buspirone for the Treatment of Anxiety in Youth with Autism Spectrum Disorders
Lead Sponsor:
Massachusetts General Hospital
Conditions:
Autism Spectrum Disorder
Anxiety
Eligibility:
All Genders
6-17 years
Phase:
PHASE2
Brief Summary
The main objective of this exploratory 8-week pilot study is to evaluate the safety and efficacy of buspirone for the treatment of anxiety in youth (ages 6-17 years) with autism spectrum disorders. Th...
Eligibility Criteria
Inclusion
- Male or female participants between 6 and 17 years of age
- DSM-5 ASD diagnostic criteria as established by clinical diagnostic interview
- Participants with a score of ≥60 or more on the Anxiety/Depression subscale of CBCL
- Subjects can be taking psychotropic medications if they have been on the medication for at least 4 weeks prior to initiating study treatment and if they are on a stable dose, provided the medication is not listed in the Concomitant Medications section of the protocol.
Exclusion
- History of active seizure disorder (EEG suggestive of seizure activity and/or history of seizure in last 1 month)
- Subjects with a medical condition or treatment that will either jeopardize subject safety or affect the scientific merit of the study, including:
- Pregnant or nursing females
- Organic brain disorders
- Uncorrected hypothyroidism or hyperthyroidism
- Clinically significant abnormalities on ECG (e.g., QT prolongation, arrhythmia)
- History of renal or hepatic impairment.
- Clinically unstable psychiatric conditions or judged to be at serious suicidal risk
- Current diagnosis of schizophrenia or bipolar disorder
- History of substance use (except nicotine or caffeine) within past 3 months or urine drug screen positive for substances of abuse
- Current treatment with medication with primary central nervous system activity (as specified in the Concomitant Medication section of the protocol)
- A non-responder or history of intolerance to buspirone, after treatment at an adequate dose and duration as determined by the clinician
- Subjects currently taking monoamine oxidase inhibitors (MAOI) and/or CYP3A4 inducers or inhibitors including nefazodone, diltiazem, verapamil, erythromaycin, itraconazole, or rifampin.
Key Trial Info
Start Date :
December 1 2024
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2025
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT03432065
Start Date
December 1 2024
End Date
August 1 2025
Last Update
September 26 2024
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