What side effects are associated with this type of intervention?

Common treatments for Autism Spectrum Disorder (ASD) that are similar to Buspirone include selective serotonin reuptake inhibitors (SSRIs) such as fluoxetine, fluvoxamine, and citalopram. Known side effects of these medications can include gastrointestinal issues (nausea, diarrhea), sleep disturbances (insomnia, drowsiness), increased anxiety, agitation, and in some cases, behavioral activation or irritability. It is important to monitor for these side effects and discuss them with a healthcare provider to ensure the best treatment plan.

What prior FDA approvals exist?

The FDA has approved two medications specifically for the treatment of irritability associated with Autism Spectrum Disorder: risperidone and aripiprazole. Both of these drugs are atypical antipsychotics that primarily target dopamine and serotonin receptors. While Buspirone, a serotonin 5-HT1A receptor partial agonist, is being studied for its potential to treat anxiety in youth with ASD, it is not yet FDA-approved for this indication. Other treatments for ASD symptoms often include selective serotonin reuptake inhibitors (SSRIs) like fluoxetine, which are used off-label to manage anxiety and repetitive behaviors.

What other types of research exist?

Promising novel alternatives to Buspirone for treating Autism Spectrum Disorder in 2024 include oxytocin, which has been studied for its effects on social impairments and serotonergic modulation in ASD patients. Additionally, selective serotonin reuptake inhibitors (SSRIs) like fluoxetine and sertraline, which have been used in related anxiety and obsessive-compulsive disorders, may also be considered.

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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 below

Select...

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

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline to 8 weeks for reporting.

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 • NCT00875836

49%

Other

41%

Dizziness or lightheaded

41%

Gastrointestinal

32%

Headache

22%

Congestion

19%

Drowsiness

18%

Insomnia

15%

Sinus/allergies/flu

13%

Musculoskeletal

Anxiety or Depression

100%

80%

60%

40%

20%

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

0 / 1Eligibility criteria met

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.