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

Sponsor

Massachusetts General Hospital (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT03432065

Collaborator

(none)

Enrollment

Location

Arm

Anticipated Duration (Months)

1.9

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Autism Spectrum Disorder Anxiety	Drug: Buspirone	Phase 2

Study Design

Study Type:

Interventional

Anticipated Enrollment :

15 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Anticipated Study Start Date :

Dec 1, 2022

Anticipated Primary Completion Date :

Aug 1, 2023

Anticipated Study Completion Date :

Aug 1, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Buspirone Buspirone tablets will be administered twice daily, and will be titrated to a maximum daily dose of 60mg for 8 weeks.	Drug: Buspirone Children with autism spectrum disorders will receive buspirone treatment for eight weeks. Buspirone will be titrated to the maximum daily dose during the first four weeks of the trial (dose titration phase). Week 4 onwards, subjects will be maintained on maximum achieved dose until the end of the trial. During the titration phase, total dose will be increased by 10mg at each visit and by 5mg on the 4th day after each visit.

Arm

Intervention/Treatment

Experimental: Buspirone

Buspirone tablets will be administered twice daily, and will be titrated to a maximum daily dose of 60mg for 8 weeks.

Drug: Buspirone

Children with autism spectrum disorders will receive buspirone treatment for eight weeks. Buspirone will be titrated to the maximum daily dose during the first four weeks of the trial (dose titration phase). Week 4 onwards, subjects will be maintained on maximum achieved dose until the end of the trial. During the titration phase, total dose will be increased by 10mg at each visit and by 5mg on the 4th day after each visit.

Outcome Measures

Primary Outcome Measures

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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

6 Years to 17 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.