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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
No Placebo-Only Group
Summary
This trial is testing buspirone, a medication that helps calm the brain, to see if it can reduce anxiety in children and teenagers with autism. The study will last for a few months and aims to check if the medication is safe and effective for this group. Buspirone is used to treat generalized anxiety disorder in children and may be useful in developmental disorders in which brain serotonin synthesis is altered.
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.
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.
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 belowSelect...
I am between 6 and 17 years old.
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
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Reduction in Child and Adolescent Symptom Inventory-5-Anxiety (CASI-Anx) 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
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 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
Research Highlights
Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
Common treatments for Autism Spectrum Disorder (ASD) often target neurotransmitter systems to alleviate symptoms such as anxiety, irritability, and repetitive behaviors. Buspirone, a serotonin 5-HT1A receptor partial agonist, works by modulating serotonin levels, which can help reduce anxiety—a common issue in ASD patients.
This mechanism is crucial as it addresses the imbalance in neurotransmitter systems that may contribute to the behavioral and emotional symptoms of ASD. Other treatments, such as selective serotonin reuptake inhibitors (SSRIs), also aim to increase serotonin availability, further highlighting the importance of serotonin regulation in managing ASD symptoms.
Understanding these mechanisms helps in tailoring treatments to improve the quality of life for ASD patients.
Find a Location
Who is running the clinical trial?
Massachusetts General HospitalLead Sponsor
3,006 Previous Clinical Trials
13,307,282 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
Eligibility Criteria:
This trial includes the following eligibility criteria:- I've been on a stable dose of my mental health medication for at least 4 weeks.I am between 6 and 17 years old.I have had a seizure or signs of seizure activity in the last month.
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.
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