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Anxiolytic

Buspirone for Anxiety in Autism

Phase 2
Waitlist Available
Led By Atilla Ceranoglu, 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
Male or female participants between 6 and 17 years of age
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 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.

Who is the study for?
This trial is for children and teens aged 6-17 with autism spectrum disorders who also experience anxiety, as indicated by a specific score on the CBCL Anxiety/Depression subscale. They must meet DSM-5 criteria for ASD and can be on stable psychotropic medications not listed in the protocol's Concomitant Medications section. Those with buspirone intolerance, seizure disorders, certain ECG abnormalities, or unstable psychiatric conditions cannot participate.Check my eligibility
What is being tested?
The study tests the safety and effectiveness of Buspirone in treating anxiety among youth with autism over an 8-week period. It aims to inform a larger future trial. Participants will receive Buspirone while their health outcomes are monitored to assess any changes in their anxiety levels.See study design
What are the potential side effects?
Buspirone may cause side effects such as dizziness, nausea, headache, nervousness, lightheadedness when standing up quickly from sitting or lying down (orthostatic hypotension), and sometimes excitement rather than relaxation.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I am between 6 and 17 years old.

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Reduction in Child and Adolescent Symptom Inventory-5-Anxiety (CASI-Anx) 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
Buspirone
Placebo

Trial Design

1Treatment groups
Experimental Treatment
Group I: BuspironeExperimental Treatment1 Intervention
Buspirone tablets will be administered twice daily, and will be 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
13,198,340 Total Patients Enrolled
42 Trials studying Autism Spectrum Disorder
3,113 Patients Enrolled for Autism Spectrum Disorder
Atilla Ceranoglu, MDPrincipal InvestigatorMassachusetts General Hospital

Media Library

Buspirone (Anxiolytic) Clinical Trial Eligibility Overview. Trial Name: NCT03432065 — Phase 2
Autism Spectrum Disorder Research Study Groups: Buspirone
Autism Spectrum Disorder Clinical Trial 2023: Buspirone Highlights & Side Effects. Trial Name: NCT03432065 — Phase 2
Buspirone (Anxiolytic) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03432065 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is there any precedent for using Buspirone in medical research?

"At this time, there are 9 clinical trials actively researching buspirone. None of them have reached the final phase (Phase 3), yet they span across nine different locations in Tianjin."

Answered by AI

How many participants are enrolled in this clinical investigation?

"At this moment, the trial is not open for enrollment. Initially posted on December 1st 2022 and last updated January 11th 2022; if you are looking to participate in other trials, there are 1632 studies recruiting patients with autism spectrum disorder and 9 clinical trials enrolling participants who will receive Buspirone medication."

Answered by AI

Are there any potential candidates currently welcome to join this experiment?

"This medical trial is presently not accepting patients. The protocol was initially submitted on December 1st, 2022 and has been edited as recently as January 11th, 2022. If you search for alternative studies relating to autism spectrum disorder, there are 1632 trials that are actively recruiting participants; 9 of which involve Buspirone."

Answered by AI

Is there an opportunity for me to participate in this research initiative?

"For eligibility in this medical trial, individuals must possess Autism Spectrum Disorder and be aged between 6 to 17 years old. This investigation is looking for 15 participants total."

Answered by AI

Is the age limit higher than 40 for this clinical experimentation?

"This research project is open to participants who have surpassed the age of 6 and are below 17 years old."

Answered by AI

Has the Food and Drug Administration granted authorization for Buspirone?

"There is clinical evidence of Buspirone's safety, so it received a rating of 2."

Answered by AI

Who else is applying?

What state do they live in?
Massachusetts
New York
Pennsylvania
How old are they?
18 - 65
What site did they apply to?
Massachusetts General Hospital
What portion of applicants met pre-screening criteria?
Met criteria

How responsive is this trial?

Typically responds via
Phone Call
Most responsive sites:
  1. Massachusetts General Hospital: < 48 hours
Average response time
  • < 2 Days
Recent research and studies
clinicaltrials.govStudy
A Pilot Study of Buspirone for the Treatment of Anxiety in Youth With Autism Spectrum Disorders
Tolga A Ceranoglu 2024. "A Pilot Study of Buspirone for the Treatment of Anxiety in Youth With Autism Spectrum Disorders". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03432065.
All > Asd > Anxiety
~10 spots leftby Aug 2025
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