Buspirone for Anxiety in Autistic Youth

February 24, 2026 updated by: Robyn P. Thom, M.D., Massachusetts General Hospital

A Randomized Controlled Trial of Buspirone for Anxiety in Autistic Youth

The purpose of the study is to do a preliminary trial to determine if buspirone is effective, safe, and tolerable in autistic youth with anxiety.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

After being informed about the study and potential risks, all patients or their legal guardians giving written informed consent will be screened for study eligibility. Patients who meet the eligibility requirements will participate in a 16-week, flexibly-dosed, randomized controlled trial of buspirone versus placebo. The dose of buspirone will be adjusted over the first 12 weeks of the study and a stable dose will be maintained for the final four weeks of the trial. Adverse effects will be reviewed at each visit and standardized measures of anxiety will be conducted at weeks 4, 8, 12, and 16.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
20

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Age 7-17 years
  2. Diagnosis of Autism Spectrum Disorder (ASD) confirmed by the study clinician using the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) criteria and Social Communication Questionnaire (SCQ)
  3. Diagnosis of social phobia, separation anxiety disorder, or generalized anxiety disorder of at least moderate severity based on the Anxiety and Related Disorders Interview Schedule (ADIS), 5-item Pediatric Anxiety Rating Scale (PARS) score ≥10, and Clinical Global Impression Severity subscale (CGI-S) ≥4
  4. IQ ≥50 based on Stanford Binet, 5th Edition Abbreviated IQ test or the Kaufman Brief Intelligence Test, 2nd Edition (KBIT-2)
  5. Stable medications for ≥30 days
  6. English speaking
  7. Ability to swallow buspirone capsules or liquid suspension

Exclusion Criteria:

  1. Known diagnosis of a genetic syndrome associated with ASD (e.g. Fragile X syndrome, Angelman syndrome) based on parent report
  2. Known cardiac arrythmia based on parent report
  3. Current primary diagnosis of bipolar disorder, psychosis, substance use disorder, posttraumatic stress disorder, eating disorder, or major depressive disorder in the opinion of the PI
  4. Any past or present conditions that would make treatment with buspirone unsafe
  5. Current use of any of the following psychotropic medications: SSRIs, SNRIs, mirtazapine, benzodiazepines, tricyclic antidepressants, monoamine oxidase inhibitors, mood stabilizers, or antipsychotics
  6. Previous adequate trial of buspirone (≥20 mg/day for at least 4 weeks) or significant adverse effects
  7. Aberrant Behavior Checklist Irritability subscale score (ABC-I) ≥18
  8. Pregnancy or sexual activity without the use of an acceptable form of birth control in females of childbearing age
  9. Acutely unstable medical/psychiatric condition (e.g. self-injury, suicidality) that would preclude study participation in the opinion of the PI
  10. Inability to tolerate Bittium Faros device in the opinion of the parent or a known allergy to adhesives

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Placebo Comparator: Placebo
Drug: Placebo
Matching placebo capsules/liquid formulation will be prepared.
Active Comparator: Buspirone
Drug: buspirone
Buspirone, an anxiety medication that is FDA approved for generalized anxiety disorder in adults, will be the active comparator for this trial.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Mean 16-Week Change in Pediatric Anxiety Rating Scale (PARS) 5-Item Total Score
Time Frame: Baseline, Week 4, Week 8, Week 2, Week 16; Change from Baseline to Week 16 reported
The PARS, a clinician-administered measure of child anxiety symptom severity based on both patient and parent-report will be the primary outcome measure. It has demonstrated inter-rater and test-retest reliability, and has previously been used by our group as the primary outcome measure in a RCT of mirtazapine for anxiety in youth with ASD, demonstrating sensitivity to change. The 5-item PARS score will be the primary outcome measure for this trial. Scaled score ranges from 0-25 with higher scores indicating more severe anxiety symptoms.
Baseline, Week 4, Week 8, Week 2, Week 16; Change from Baseline to Week 16 reported

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Proportion of Participants who Responded to Treatment at 16 Weeks According to the Improvement Item of the Clinical Global Impression-Improvement (CGI-I) (Response Defined as CGI-I = 1 or 2)
Time Frame: Week 4, Week 8, Week 12, Week 16. Week 16 score reported.
The Clinical Global Impressions Global Improvement (CGI-I) is designed to take into account all factors to arrive at an assessment of response to treatment. The CGI-I scale ranges from 1 to 7 (1=very much improved; 2=much improved; 3=minimally improved; 4=no change; 5=minimally worse; 6=much worse; 7=very much worse), with lower scales indicating improvement (1=very much improved; 2=much improved). In this study, the CGI-I will be focused on the target symptom of anxiety. Participants with a CGI-I score of 1 or 2 will be classified as responders.
Week 4, Week 8, Week 12, Week 16. Week 16 score reported.
Mean 16-Week Change in Clinical Global Impression Severity Subscale (CGI-S)
Time Frame: Baseline, Week 4, Week 8, Week 12, Week 16. Change from Baseline to Week 16 reported.
The CGI-S is rated on a scale from 1 to 7, where 1 = normal, not at all ill; 3 = mildly ill; 5 = markedly ill; 7 = among the most extremely ill patients. The CGI-S will be rated based on the severity of anxiety symptoms.
Baseline, Week 4, Week 8, Week 12, Week 16. Change from Baseline to Week 16 reported.
Mean 16-Week Change in Parent-Rated Anxiety Scale for Autism Spectrum Disorder (PRAS-ASD) Score
Time Frame: Baseline, Week 8, Week 16. Change from Baseline to Week 16 reported.
The PRAS-ASD is a novel parent-rated 25-item scale with demonstrated reliability and validity. Scores range from 0-75, with higher scores indicating more severe parent-rated anxiety.
Baseline, Week 8, Week 16. Change from Baseline to Week 16 reported.

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Mean 16-Week Change in Aberrant Behavior Checklist (ABC-2) Irritability Subscale Score
Time Frame: Baseline, Week 8, Week 16; Change from Baseline to Week 16 reported
The ABC-2 is a 58-item questionnaire with 5 subscales derived by factor analysis. It has been extensively used in psychopharmacological studies of ASD and assesses many symptoms that are either central to autism or frequently a target of treatment. The Irritability Subscale is derived from 15 items, with a score range from 0-45, where higher scores indicate more severe irritability.
Baseline, Week 8, Week 16; Change from Baseline to Week 16 reported
Mean 16-Week Change in Aberrant Behavior Checklist (ABC-2) Lethargy/Social Withdrawal Subscale Score
Time Frame: Baseline, Week 8, Week 16; Change from Baseline to Week 16 reported
The ABC-2 is a 58-item questionnaire with 5 subscales derived by factor analysis. It has been extensively used in psychopharmacological studies of ASD and assesses many symptoms that are either central to autism or frequently a target of treatment. The Lethargy/Withdrawal Subscale is derived from 16 items, with a score range from 0-48 where higher scores indicate more severe Lethargy/Withdrawal symptoms.
Baseline, Week 8, Week 16; Change from Baseline to Week 16 reported
Mean 16-Week Change in Aberrant Behavior Checklist (ABC-2) Stereotypic Behavior Subscale Score
Time Frame: Baseline, Week 8, Week 16; Change from Baseline to Week 16 reported
The ABC-2 is a 58-item questionnaire with 5 subscales derived by factor analysis. It has been extensively used in psychopharmacological studies of ASD and assesses many symptoms that are either central to autism or frequently a target of treatment. The Stereotypic Behavior Subscale is derived from 7 items, with a score range of 0-21 where higher scores indicate more severe stereotypic behaviors.
Baseline, Week 8, Week 16; Change from Baseline to Week 16 reported
Mean 16-Week Change in Aberrant Behavior Checklist (ABC-2) Hyperactivity Subscale Score
Time Frame: Baseline, Week 8, Week 16; Change from Baseline to Week 16 reported
The ABC-2 is a 58-item questionnaire with 5 subscales derived by factor analysis. It has been extensively used in psychopharmacological studies of ASD and assesses many symptoms that are either central to autism or frequently a target of treatment. The Hyperactivity Subscale is derived from 16 items with a score range of 0-48, where severe scores indicate more severe hyperactivity symptoms.
Baseline, Week 8, Week 16; Change from Baseline to Week 16 reported
Mean 16-Week Change in Aberrant Behavior Checklist (ABC-2) Inappropriate Speech Subscale Score
Time Frame: Baseline, Week 8, Week 16; Change from Baseline to Week 16 reported
The ABC-2 is a 58-item questionnaire with 5 subscales derived by factor analysis. It has been extensively used in psychopharmacological studies of ASD and assesses many symptoms that are either central to autism or frequently a target of treatment. The Inappropriate Speech Subscale is derived from 4 items with a score range of 0-12, where higher scores indicate more severe Inappropriate Speech symptoms.
Baseline, Week 8, Week 16; Change from Baseline to Week 16 reported
Mean 16-Week Change in Attention Deficit Hyperactivity Disorder Rating Scale (ADHD-RS) Score
Time Frame: Baseline, Week 16; Change from Baseline to Week 16 reported
The ADHD-RS is an 18-question, parent-rated assessment reflecting DSM symptoms of ADHD. The score range is 0-54, with higher scores indicating more severe ADHD symptoms.
Baseline, Week 16; Change from Baseline to Week 16 reported
Mean 16-Week Change in Children's Sleep Habits Questionnaire (CSHQ) Total Score
Time Frame: Baseline, Week 16; Change from Baseline to Week 16 is reported
The CSHQ is a 52-question parent survey used to assess sleep difficulties. 33 items are used to generate the total score, which ranges from 33-99, with a cutoff of >41 suggesting clinically significant sleep problems. Higher scores are indicative of more severe sleep problems.
Baseline, Week 16; Change from Baseline to Week 16 is reported
Mean 16-Week Change in Heart Rate Variability (HRV) at Rest
Time Frame: Baseline, Week 16; Change from Baseline to Week 16 reported
The log[root mean square of successive differences (RMSSD)] will be utilized as the primary HRV measure. It will be measured at rest in the laboratory setting pre- and post-treatment.
Baseline, Week 16; Change from Baseline to Week 16 reported
Mean 16-Week Change in Heart Rate Variability (HRV) with Startle
Time Frame: Baseline, Week 16; Change from Baseline to Week 16 reported
The log[root mean square of successive differences (RMSSD)] will be utilized as the primary HRV measure. It will be measured during a startle tone in the laboratory setting pre- and post-treatment.
Baseline, Week 16; Change from Baseline to Week 16 reported
Mean 16-Week Change in Heart Rate Variability (HRV) During a Working Memory Task
Time Frame: Baseline, Week 16; Change from Baseline to Week 16 reported
The log[root mean square of successive differences (RMSSD)] will be utilized as the primary HRV measure. It will be measured during a working memory task in the laboratory setting pre- and post-treatment.
Baseline, Week 16; Change from Baseline to Week 16 reported
Mean 16-Week Change in Heart Rate Variability (HRV) During Cold Pressor Task
Time Frame: Baseline, Week 16; Change from Baseline to Week 16 reported
The log[root mean square of successive differences (RMSSD)] will be utilized as the primary HRV measure. It will be measured during the Cold Pressor Task in the laboratory setting pre- and post-treatment.
Baseline, Week 16; Change from Baseline to Week 16 reported
Mean 16-Week Change in Blood Pressure
Time Frame: Baseline, Week 16; Change from Baseline to Week 16 reported
Blood pressure will be measured at rest in the laboratory setting pre- and post-treatment.
Baseline, Week 16; Change from Baseline to Week 16 reported
Mean 16-Week Change in Skin Conductance Level at Rest
Time Frame: Baseline, Week 16; Change from Baseline to Week 16 reported
Skin conductance level will be measured at rest in the laboratory setting pre- and post-treatment.
Baseline, Week 16; Change from Baseline to Week 16 reported
Mean 16-Week Change in Skin Conductance Level with Startle
Time Frame: Baseline, Week 16; Change from Baseline to Week 16 reported
Skin conductance level will be measured during a startle tone in the laboratory setting pre- and post-treatment.
Baseline, Week 16; Change from Baseline to Week 16 reported
Mean 16-Week Change in Skin Conductance Level During Working Memory Task
Time Frame: Baseline, Week 16; Change from Baseline to Week 16 reported
Skin conductance level will be measured during a working memory task in the laboratory setting pre- and post-treatment.
Baseline, Week 16; Change from Baseline to Week 16 reported
Mean 16-Week Change in Skin Conductance Level During Cold Pressor Task
Time Frame: Baseline, Week 16; Change from Baseline to Week 16 reported
Skin conductance level will be measured during the Cold Pressor Task in the laboratory setting pre- and post-treatment.
Baseline, Week 16; Change from Baseline to Week 16 reported
Mean 16-Week Change in Ambulatory Heart Rate Variability
Time Frame: Baseline, Week 16; Change from Baseline to Week 16 reported
Heart rate variability (HRV) will be assessed remotely throughout the 16-week trial using the Bittium Faros holter monitor. Change in log[root mean square of successive differences (RMSSD)] over the course of the trial will be quantified.
Baseline, Week 16; Change from Baseline to Week 16 reported
Mean 16-Week Change in Ambulatory Accelerometry Magnitude
Time Frame: Baseline, Week 16; Change from Baseline to Week 16 reported
Accelerometry magnitude will be assessed remotely throughout the 16-week trial using the Bittium Faros holter monitor, which records acceleration vector components (x, y, and z). Accelerometry magnitude (m/s^2) will be calculated using the vector sum of the acceleration vector components. Change in accelerometry magnitude over the course of the trial will be quantified.
Baseline, Week 16; Change from Baseline to Week 16 reported

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Massachusetts General Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
August 1, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
February 1, 2029

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 1, 2029

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 13, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 24, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 27, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
February 27, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 24, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 2025P003437

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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