A Phase 4 interventional study of buspirone and Placebo in Anxiety and Autism Spectrum Disorder, sponsored by Massachusetts General Hospital. Recruiting at 1 site in United States. Open to participants aged 7 Years to 17 Years. Per ClinicalTrials.gov, last updated 2026-09-17.
Sponsored by Massachusetts General Hospital · Phase 4, Interventional, and Treatment
Among 14 studies testing buspirone in Anxiety Disorders — 3 open to participants now, 3 under way, none of them phase 3. Buspirone · Anxiety Disorders.
Among the 14 studies testing buspirone in Anxiety Disorders, this one is the 8th largest by planned enrollment, is the only one that started in 2026, is one of 5 in phase 4, and was the 14th registered.
7,201 studies on the registry are indexed under Anxiety Disorders; 1,682 are open to participants now.
This study's planned enrollment of 20 is below the median of 80 across 6,057 interventional studies indexed under Anxiety Disorders.
Browse Anxiety Disorders studies →3 of the 14 studies testing buspirone in Anxiety Disorders are open now, in 2 countries. Each count lists the studies.
Buspirone: first FDA approval 1986 (BUSPAR). What it is approved for, and how studies give it, is on its page →
Of the 943 Anxiety Disorders studies recruiting now, 416 (44%) set no upper age limit and 460 (49%) stop at 75 or younger; 232 take children under 18; 316 take healthy volunteers.
This study: 7 Years to 17 Years · all sexes · no healthy volunteers.
The full table on the hub →14 studies; the count open now beside each. This study's row is marked.
First in 2011; this study’s year is marked. 1 started in 2026.
Median enrollment 21 across the 14 interventional studies. Of the 6 that completed or were terminated, 5 (83%) have results posted.
None of the 14 has an industry lead sponsor. The 9 most frequent:
Massachusetts General Hospital is the lead sponsor of 2,586 studies on the registry; 447 are open to participants now.
Of its 222 completed or terminated interventional studies of FDA-regulated products, 168 (76%) have results posted.
67 studies in Anxiety Disorders by Massachusetts General Hospital: 15 open now, 20 under way, none of them phase 3. Of 44 finished, 27 (61%) have results posted.
Among the 67 studies in Anxiety Disorders by Massachusetts General Hospital, this one is the 52nd largest by planned enrollment of the 64 interventional ones, is one of 3 that started in 2026, is one of 11 in phase 4, reaches primary completion later than 16 of the 19 other live ones, and was the 63rd registered.
Massachusetts General Hospital’s Anxiety Disorders studies by the year they started, since 1998.
1 of the studies testing buspirone in Anxiety Disorders that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT05511909University of Maryland, BaltimoreEvaluating Buspirone to Treat Opioid Withdrawal | 2027-01-31 |
Among the 14 studies testing buspirone in Anxiety Disorders, from their registry updates:
Nothing recorded among them since 2026-09-25.
Among Massachusetts General Hospital’s 67 in Anxiety Disorders:
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.
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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The American Psychiatric Association’s manual of mental health diagnoses. DSM-5 (2013, revised as DSM-5-TR in 2022) replaced DSM-IV, and some studies still name the older edition. “Meets DSM criteria for …” means diagnosed by that edition’s diagnostic criteria, usually by a clinician in an interview.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
DSM diagnostic criteria
The American Psychiatric Association’s manual of mental health diagnoses. DSM-5 (2013, revised as DSM-5-TR in 2022) replaced DSM-IV, and some studies still name the older edition. “Meets DSM criteria for …” means diagnosed by that edition’s diagnostic criteria, usually by a clinician in an interview.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Drug: buspirone
Drug: Placebo
Buspirone, an anxiety medication that is FDA approved for generalized anxiety disorder in adults, will be the active comparator for this trial.
Matching placebo capsules/liquid formulation will be prepared.
Mean 16-Week Change in Pediatric Anxiety Rating Scale (PARS) 5-Item Total Score
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.
Time frame: Baseline, Week 4, Week 8, Week 2, Week 16; Change from Baseline to Week 16 reported
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)
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.
Time frame: Week 4, Week 8, Week 12, Week 16. Week 16 score reported.
Mean 16-Week Change in Clinical Global Impression Severity Subscale (CGI-S)
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.
Time frame: 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
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.
Time frame: Baseline, Week 8, Week 16. Change from Baseline to Week 16 reported.
Mean 16-Week Change in Aberrant Behavior Checklist (ABC-2) Irritability Subscale Score
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.
Time frame: 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
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.
Time frame: 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
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.
Time frame: 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
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.
Time frame: 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
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.
Time frame: 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
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.
Time frame: Baseline, Week 16; Change from Baseline to Week 16 reported
Mean 16-Week Change in Children's Sleep Habits Questionnaire (CSHQ) Total Score
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.
Time frame: Baseline, Week 16; Change from Baseline to Week 16 is reported
Mean 16-Week Change in Heart Rate Variability (HRV) at Rest
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.
Time frame: Baseline, Week 16; Change from Baseline to Week 16 reported
Mean 16-Week Change in Heart Rate Variability (HRV) with Startle
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.
Time frame: Baseline, Week 16; Change from Baseline to Week 16 reported
Mean 16-Week Change in Heart Rate Variability (HRV) During a Working Memory Task
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.
Time frame: Baseline, Week 16; Change from Baseline to Week 16 reported
Mean 16-Week Change in Heart Rate Variability (HRV) During Cold Pressor Task
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.
Time frame: Baseline, Week 16; Change from Baseline to Week 16 reported
Mean 16-Week Change in Blood Pressure
Blood pressure will be measured at rest in the laboratory setting pre- and post-treatment.
Time frame: Baseline, Week 16; Change from Baseline to Week 16 reported
Mean 16-Week Change in Skin Conductance Level at Rest
Skin conductance level will be measured at rest in the laboratory setting pre- and post-treatment.
Time frame: Baseline, Week 16; Change from Baseline to Week 16 reported
Mean 16-Week Change in Skin Conductance Level with Startle
Skin conductance level will be measured during a startle tone in the laboratory setting pre- and post-treatment.
Time frame: Baseline, Week 16; Change from Baseline to Week 16 reported
Mean 16-Week Change in Skin Conductance Level During Working Memory Task
Skin conductance level will be measured during a working memory task in the laboratory setting pre- and post-treatment.
Time frame: Baseline, Week 16; Change from Baseline to Week 16 reported
Mean 16-Week Change in Skin Conductance Level During Cold Pressor Task
Skin conductance level will be measured during the Cold Pressor Task in the laboratory setting pre- and post-treatment.
Time frame: Baseline, Week 16; Change from Baseline to Week 16 reported
Mean 16-Week Change in Ambulatory Heart Rate Variability
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.
Time frame: Baseline, Week 16; Change from Baseline to Week 16 reported
Mean 16-Week Change in Ambulatory Accelerometry Magnitude
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.
Time frame: Baseline, Week 16; Change from Baseline to Week 16 reported
Plan to share: No
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Studies of the drug tested here: Buspirone
Massachusetts General Hospital →