Buspirone for Anxiety in Autism

Overseen By Meredith O'Connor, BS

Age: < 18

Sex: Any

Trial Phase: Phase 2

Sponsor: Massachusetts General Hospital

Must not be taking: MAOIs, CYP3A4 inducers

Disqualifiers: Seizure disorder, Schizophrenia, Bipolar, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Approved in 3 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

Duration: 8 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

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.

Will I have to stop taking my current medications?

You can continue taking your current medications if you've been on a stable dose for at least 4 weeks, unless they are listed in the protocol's Concomitant Medications section. You cannot take certain medications like MAOIs or CYP3A4 inducers or inhibitors.

Is buspirone safe for use in humans?

Buspirone is generally considered safe and well-tolerated in humans, including children with autism spectrum disorder, and it does not have serious adverse reactions or negative effects on cognition. ^{1 2 3 4 5}

How is the drug buspirone unique for treating anxiety in autism?

Buspirone is unique because it is a non-benzodiazepine drug that works by partially activating serotonin receptors, which can help reduce anxiety without causing sedation or dependency. This makes it different from traditional anxiety medications, and it may be particularly useful for people who need a gradual onset of relief and are concerned about the side effects of other drugs. ^{3 6 7 8 9}

What data supports the effectiveness of the drug buspirone for anxiety in autism?

Buspirone is effective in reducing anxiety symptoms in generalized anxiety disorder and has been shown to be as effective as some benzodiazepines, with fewer sedative effects. It is also used for other anxiety-related conditions, suggesting potential benefits for anxiety in autism. ^{3 10 11 12 13}

Who Is on the Research Team?

Atilla Ceranoglu, MD

Principal Investigator

Massachusetts General Hospital

Are You a Good Fit for This Trial?

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.

Inclusion 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.

Participants must meet DSM-5 ASD diagnostic criteria as established by clinical diagnostic interview

Exclusion Criteria

Subjects with a medical condition or treatment that will either jeopardize subject safety or affect the scientific merit of the study, including: pregnant or nursing females, organic brain disorders, uncorrected hypothyroidism or hyperthyroidism, clinically significant abnormalities on ECG (e.g., QT prolongation, arrhythmia), history of renal or hepatic impairment, clinically unstable psychiatric conditions or judged to be at serious suicidal risk, current diagnosis of schizophrenia or bipolar disorder, history of substance use (except nicotine or caffeine) within past 3 months or urine drug screen positive for substances of abuse, current treatment with medication with primary central nervous system activity (as specified in the Concomitant Medication section of the protocol), a non-responder or history of intolerance to buspirone, after treatment at an adequate dose and duration as determined by the clinician, subjects currently taking monoamine oxidase inhibitors (MAOI) and/or CYP3A4 inducers or inhibitors including nefazodone, diltiazem, verapamil, erythromaycin, itraconazole, or rifampin.

I have had a seizure or signs of seizure activity in the last month.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive buspirone tablets twice daily, titrated to a maximum daily dose of 60mg for 8 weeks

8 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Buspirone

Trial Overview 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.

How Is the Trial Designed?

Group I: Buspirone Experimental Treatment 1 Intervention

Buspirone tablets will be administered twice daily, and will be titrated to a maximum daily dose of 60mg for 8 weeks.

Buspirone is already approved in United States, European Union, Canada for the following indications:

Approved in United States as Buspar for:

• Generalized anxiety disorder

Approved in European Union as Buspirone for:

• Generalized anxiety disorder

Approved in Canada as Buspirone for:

• Generalized anxiety disorder

Who Is Running the Clinical Trial?

Massachusetts General Hospital

Lead Sponsor

Trials

3,066

Recruited

13,430,000+

Published Research Related to This Trial

Buspirone is an anxiolytic medication that works differently from traditional benzodiazepines, showing comparable effectiveness to diazepam in reducing anxiety but with significantly less sedation and no abuse potential.

It acts as both a dopamine agonist and antagonist, interacting with various neurochemical systems in the brain, and has a rapid onset of action, achieving peak serum concentrations within one hour.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Buspirone hydrochloride: a unique new anxiolytic agent. Pharmacokinetics, clinical pharmacology, abuse potential and clinical efficacy. Goldberg, HL.[2019]

Citations

1. Russia (Federation) pubmed.ncbi.nlm.nih.gov

[The use of buspirone in clinical practice]. [2018]

2. Korea (South) pubmed.ncbi.nlm.nih.gov

5-HT1A Partial Agonist Tandospirone for Behavioral and Psychological Symptoms in Oldest-old Patients with Dementia at a Special Elderly Nursing Home. [2023]

3. United States pubmed.ncbi.nlm.nih.gov

Buspirone hydrochloride: a unique new anxiolytic agent. Pharmacokinetics, clinical pharmacology, abuse potential and clinical efficacy. [2019]

4. France pubmed.ncbi.nlm.nih.gov

[Buspirone: pharmacological and clinical properties of the first member of a new anxiolytic drug family]. [2019]

5. United States pubmed.ncbi.nlm.nih.gov

Buspirone in the long-term treatment of generalized anxiety disorder. [2013]

6. United States pubmed.ncbi.nlm.nih.gov

Buspirone in Autism Spectrum Disorder: A Systematic Review. [2023]

7. United States pubmed.ncbi.nlm.nih.gov

Buspirone in the management of anxiety and irritability in children with pervasive developmental disorders: results of an open-label study. [2019]

8. England pubmed.ncbi.nlm.nih.gov

Buspirone and lorazepam abuse liability in humans: behavioral effects, subjective effects and choice. [2019]

9. United States pubmed.ncbi.nlm.nih.gov

Lack of deleterious effects of buspirone on cognition in healthy male volunteers. [2022]

10. Germany pubmed.ncbi.nlm.nih.gov

Effect of buspirone on the behavioral regulation of rats in low versus high anxiety conditions. [2013]

11. United States pubmed.ncbi.nlm.nih.gov

Buspirone in clinical practice. [2013]

12. Spain pubmed.ncbi.nlm.nih.gov

[Azaspirodecanodiones in clinical psychiatry]. [2013]

13. Spain pubmed.ncbi.nlm.nih.gov

[Buspirone: a new non-benzodiazepine anxiolytic drug]. [2013]