A Pilot Study of Buspirone for the Treatment of Anxiety in Youth With Autism Spectrum Disorders
- Registration Number
- NCT03432065
- Lead Sponsor
- Massachusetts General Hospital
- 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. The study results will be used to generate hypotheses for a larger randomized-controlled trial with explicit hypotheses and sufficient statistical power.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- All
- Target Recruitment
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Buspirone Buspirone Buspirone tablets will be administered twice daily, and will be titrated to a maximum daily dose of 60mg for 8 weeks.
- Primary Outcome Measures
Name Time Method Reduction in Child and Adolescent Symptom Inventory-5-Anxiety (CASI-Anx) Score Baseline to 8 Weeks The primary outcome measure of efficacy will be assessed by the reduction in anxiety symptom severity as measured by a change from baseline on the Child and Adolescent Symptom Inventory-5-Anxiety (CASI-Anx) scores. Responders are defined as those who demonstrate a \>30% reduction on the CASI-Anx.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Massachusetts General Hospital
🇺🇸Boston, Massachusetts, United States