Buspirone for Disease

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Disease+7 More
Buspirone - Drug
Eligibility
< 18
All Sexes
What conditions do you have?
Select

Study 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.

Eligible Conditions
  • Disease
  • Autoimmune Diseases
  • Anxiety

Treatment Effectiveness

Effectiveness Progress

1 of 3

Study Objectives

2 Primary · 0 Secondary · Reporting Duration: Baseline to 8 weeks

Baseline to 8 weeks
Clinical Global Impression-Anxiety (CGI-Anxiety) Improvement Score
Reduction in Pediatric Anxiety Rating Scale (PARS) score

Trial Safety

Safety Progress

1 of 3

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

9 Total Participants · 1 Treatment Group

Primary Treatment: Buspirone · No Placebo Group · N/A

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
30,832,184 Total Patients Enrolled
136 Trials studying Disease
20,372 Patients Enrolled for Disease
Gagan Joshi, MDPrincipal InvestigatorMassachusetts General Hospital
11 Previous Clinical Trials
426 Total Patients Enrolled
9 Trials studying Disease
265 Patients Enrolled for Disease

Eligibility Criteria

Age < 18 · All Participants · 6 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
You are between 6 and 17 years of age.
You have a diagnosis of autism spectrum disorders by meeting DSM-IV-TR PDD diagnostic criteria of autistic disorder, Asperger's disorder, or PDD-NOS as established by clinical diagnostic interview.
Subjects can be on psychotropic drugs if they have been on the medication for at least 4 weeks prior to initiating trial treatment and if they are stable, provided the medication is not listed in the Concomitant Medications section of the protocol.

About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 18th, 2021

Last Reviewed: November 8th, 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.