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NCT Number: NCT07439042

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.

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Key information

Conditions

Anxiety Anxiety Disorders Autism Spectrum Disorder Autistic Disorder Child Development Disorders, Pervasive Mental Disorders Neurodevelopmental Disorders

Age range

7 year–17 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age 7-17 years
  • 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)
  • 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
  • IQ ≥50 based on Stanford Binet, 5th Edition Abbreviated IQ test or the Kaufman Brief Intelligence Test, 2nd Edition (KBIT-2)
  • Stable medications for ≥30 days
  • English speaking
  • Ability to swallow buspirone capsules or liquid suspension

Exclusion criteria

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

Treatment and study plan

Buspirone

Drug

Buspirone, an anxiety medication that is FDA approved for generalized anxiety disorder in adults, will be the active comparator for this trial.

Placebo

Drug

Matching placebo capsules/liquid formulation will be prepared.

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

  2. 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.

  3. 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.

Other outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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.

  7. 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.

  8. 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.

  9. 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.

  10. 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.

  11. 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.

  12. 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.

  13. 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.

  14. 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.

  15. 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.

  16. 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.

  17. 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.

  18. 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Robyn P. Thom, MD

CONTACT

[email protected]

781-860-1711

Sponsors and collaborators

Lead sponsor

Massachusetts General Hospital

Other

Registry information

Official study title

A Randomized Controlled Trial of Buspirone for Anxiety in Autistic Youth

Important dates

Study start
2026
Primary completion
2029
Study completion
2029
First posted
Feb 27, 2026
Registry last updated
Feb 27, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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