Buspirone for Autism Spectrum Disorder

Phase-Based Progress Estimates
1
Effectiveness
2
Safety
Autism Spectrum Disorder+6 More
Buspirone - Drug
Eligibility
< 18
All Sexes
What conditions do you have?
Select

Study Summary

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

Eligible Conditions
  • Autism Spectrum Disorder
  • Autism Spectrum Disorders
  • Anxiety

Treatment Effectiveness

Effectiveness Progress

1 of 3

Study Objectives

1 Primary · 0 Secondary · Reporting Duration: Baseline to 8 Weeks

Baseline to 8 Weeks
Reduction in Child and Adolescent Symptom Inventory-5-Anxiety (CASI-Anx) Score

Trial Safety

Safety Progress

2 of 3
This is further along than 68% of similar trials

Side Effects for

Buspirone
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
This histogram enumerates side effects from a completed 2016 Phase 4 trial (NCT00875836) in the Buspirone ARM group. Side effects include: Other with 49%, Dizziness or lightheaded with 41%, Gastrointestinal with 41%, Headache with 32%, Congestion with 22%.

Trial Design

1 Treatment Group

Buspirone
1 of 1

Experimental Treatment

15 Total Participants · 1 Treatment Group

Primary Treatment: Buspirone · No Placebo Group · Phase 2

Buspirone
Drug
Experimental Group · 1 Intervention: Buspirone · Intervention Types: Drug
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Buspirone
FDA approved

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: baseline to 8 weeks

Who is running the clinical trial?

Massachusetts General HospitalLead Sponsor
2,678 Previous Clinical Trials
30,832,178 Total Patients Enrolled
39 Trials studying Autism Spectrum Disorder
2,586 Patients Enrolled for Autism Spectrum Disorder
Atilla Ceranoglu, MDPrincipal InvestigatorMassachusetts General Hospital

Eligibility Criteria

Age < 18 · All Participants · 4 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
Participants who scored ≥60 on the Anxiety/Depression subscale of CBCL were more likely to have clinically significant anxiety or depression.
Subjects who are currently taking psychotropic medications may continue to do so if they have been taking the medication for at least 4 weeks prior to initiating study treatment and if they are on a stable dose
were recruited Participants between the ages of 6 and 17 were recruited, male or female.
The following are the DSM-5 ASD diagnostic criteria as established by clinical diagnostic interview: 1

About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 24th, 2021

Last Reviewed: November 12th, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.

Who else is applying?

What state do they live in?
Pennsylvania50.0%
Massachusetts25.0%
New York25.0%
How old are they?
18 - 65100.0%
What site did they apply to?
Massachusetts General Hospital100.0%
What portion of applicants met pre-screening criteria?
Met criteria100.0%

How responsive is this trial?

Average response time
  • < 2 Days
Typically responds via
Phone Call100.0%
Most responsive sites:
  1. Massachusetts General Hospital: < 48 hours