A Pilot Study of Buspirone for the Treatment of Anxiety in Youth With Autism Spectrum Disorders
Trial Snapshot
- Phase
- Phase 2
- Status
- Not yet recruiting
- Enrollment
- 15
- Primary Endpoint
- Reduction in Child and Adolescent Symptom Inventory-5-Anxiety (CASI-Anx) Score
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 6 Years to 17 Years (Child)
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
Arms & Interventions
Buspirone
Buspirone tablets will be administered twice daily, and will be titrated to a maximum daily dose of 60mg for 8 weeks.
Intervention: Buspirone (Drug)
Outcomes
Primary Outcomes
Reduction in Child and Adolescent Symptom Inventory-5-Anxiety (CASI-Anx) Score
Time Frame: 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 Outcomes
No secondary outcomes reported
Investigators
Tolga A Ceranoglu
Medical doctor
Massachusetts General Hospital