A Pilot Study of Buspirone for the Treatment of Anxiety in Youth With Autism Spectrum Disorders

2017-P-002731

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. The study results will be used to generate hypotheses for a larger randomized-controlled trial with explicit hypotheses and sufficient statistical power.

2024-12-01

2025-08-01

2025-08-01

Not yet recruiting

Early phase I

15

Inclusion Criteria: * 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 Criteria: * 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.

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE2'], 'designInfo': {'allocation': 'NA', 'interventionModel': 'SINGLE_GROUP', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 15, 'type': 'ESTIMATED'}}

2024-03-13