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Anxiolytic

Buspirone for Anxiety in Youth with Autism Spectrum Disorders

N/A
Waitlist Available
Led By Gagan Joshi, MD
Research Sponsored by Massachusetts General Hospital
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be younger than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline to 8 weeks
Awards & highlights
No Placebo-Only Group

Summary

This trial is testing if the drug buspirone is safe and effective for treating anxiety in kids with autism spectrum disorders. The results will be used to plan a larger study with more participants.

Who is the study for?
This trial is for boys and girls aged 6-17 with autism spectrum disorders who also have anxiety. They must meet specific diagnostic criteria, have certain scores on anxiety scales, and can be on stable psychotropic drugs not listed in the protocol's exclusion section. Those with severe psychiatric conditions, recent substance use, or taking excluded medications cannot join.
What is being tested?
The study tests Buspirone's safety and effectiveness in reducing anxiety among young people with autism over an 8-week period. It will inform larger trials designed to provide more definitive answers about this treatment approach.
What are the potential side effects?
While the side effects of Buspirone are not detailed here, common ones include dizziness, nausea, headache, nervousness, lightheadedness, and excitement which may vary from person to person.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline to 8 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline to 8 weeks for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Clinical Global Impression-Anxiety (CGI-Anxiety) Improvement Score
Reduction in Pediatric Anxiety Rating Scale (PARS) score

Side effects data

From 2016 Phase 4 trial • 175 Patients • NCT00875836
49%
Other
41%
Dizziness or lightheaded
41%
Gastrointestinal
32%
Headache
22%
Congestion
19%
Drowsiness
18%
Insomnia
15%
Sinus/allergies/flu
13%
Musculoskeletal
5%
Anxiety or Depression
100%
80%
60%
40%
20%
0%
Study treatment Arm
Placebo
Buspirone

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups
Experimental Treatment
Group I: BuspironeExperimental Treatment1 Intervention
Buspirone administered in tablets twice daily titrated to a maximum daily dose of 60mg for 8 weeks.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Buspirone
2022
Completed Phase 4
~1160

Find a Location

Who is running the clinical trial?

Massachusetts General HospitalLead Sponsor
3,012 Previous Clinical Trials
13,309,262 Total Patients Enrolled
42 Trials studying Autism Spectrum Disorder
3,091 Patients Enrolled for Autism Spectrum Disorder
Gagan Joshi, MDPrincipal InvestigatorMassachusetts General Hospital
11 Previous Clinical Trials
341 Total Patients Enrolled
10 Trials studying Autism Spectrum Disorder
328 Patients Enrolled for Autism Spectrum Disorder

Media Library

Buspirone (Anxiolytic) Clinical Trial Eligibility Overview. Trial Name: NCT01850355 — N/A
Autism Spectrum Disorder Research Study Groups: Buspirone
Autism Spectrum Disorder Clinical Trial 2023: Buspirone Highlights & Side Effects. Trial Name: NCT01850355 — N/A
Buspirone (Anxiolytic) 2023 Treatment Timeline for Medical Study. Trial Name: NCT01850355 — N/A
~0 spots leftby Dec 2024
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