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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
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
- Autism Spectrum Disorder
- Anxiety
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline to 8 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline to 8 weeks
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
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 • NCT0087583649%
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
Buspirone
Placebo
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
2,928 Previous Clinical Trials
13,198,346 Total Patients Enrolled
42 Trials studying Autism Spectrum Disorder
3,119 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
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Eligibility Criteria:
This trial includes the following eligibility criteria:- You have had problems with your kidneys or liver in the past.Women who are currently pregnant or breastfeeding.You have a brain disorder.Your intelligence quotient (IQ) is less than 70.You have taken buspirone before and it did not work or you had a bad reaction to it, even when you took the recommended amount for a good amount of time.You currently have been diagnosed with schizophrenia.You can participate in the study even if you have behavior or mood disorders as long as they do not prevent you from meeting the other requirements.
Research Study Groups:
This trial has the following groups:- Group 1: Buspirone
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
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