Autism Spectrum DisordersNCT01850355
An Open-Label Trial of Buspirone for the Treatment of Anxiety in Youth With Autism Spectrum Disorders
A study testing Buspirone in people with Autism Spectrum Disorders and Anxiety, run by Massachusetts General Hospital at 1 site in United States.
Trial summary
The main objective of this exploratory 8-week pilot study is to evaluate the safety and efficacy of buspirone for the treatment of anxiety in youth (ages 6-17 years) with autism spectrum disorders. Read more about this study
- Who is it for?
- Ages 6 to 17 years
- Conditions the study is for
- Autism Spectrum Disorders, Anxiety
- What is being tested?
- Buspirone
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 9 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2013to Dec 2024
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Male or female participants between 6 and 17 years of age
- Fulfills diagnosis of autism spectrum disorders by meeting DSM-IV-TR PDD diagnostic criteria of autistic disorder, Asperger's disorder, or PDD-NOS as established by clinical diagnostic interview
- Participants with a score of ≥13 on the Pediatric Anxiety Rating Scale (PARS)
- Participants with a score of ≥60 or more on the Anxiety/Depression subscale of CBCL and CGI-Anxiety severity of ≥ 4
- Subjects can be on psychotropic drugs if they have been on the medication for at least 4 weeks prior to initiating trial treatment and if they are stable, provided the medication is not listed in the Concomitant Medications section of the protocol.
- Subjects with disruptive behavior disorders, mood, or psychosis will be allowed to participate in the study provided they do not meet any exclusionary criteria
Who cannot join
- I.Q. < 70
- DSM-IV-TR PDD diagnoses of Rett's disorder, and childhood disintegrative disorder
- History of active seizure disorder (EEG suggestive of seizure activity and/or history of seizure in last 1 month)
- 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
Show all 15Show fewer
- 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
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Massachusetts General Hospital
Boston, Massachusetts, 02114
About this study
Official title: An Open-label Trial of Buspirone for the Treatment of Anxiety in Youth With Autism Spectrum Disorders
The main objective of this exploratory 8-week pilot study is to evaluate the safety and efficacy of buspirone for the treatment of anxiety in youth (ages 6-17 years) with autism spectrum disorders. The study results will be used to generate hypothesis for a larger randomized controlled clinical trials with explicit hypotheses and sufficient statistical power.
- Conditions
- Autism Spectrum Disorders, Anxiety
- Being tested
- Buspirone
- Keywords
- Autism Spectrum Disorders, Anxiety, Children, Adolescents, Buspar, Buspirone, Pervasive Developmental Disorders
- Medical subject headings
- Autism Spectrum Disorder, Anxiety Disorders, Child Development Disorders, Pervasive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BuspironeDrug
Children with autism spectrum disorders will receive buspirone treatment for eight weeks. Buspirone will be titrated to the maximum daily dose during the first four weeks of the trial (dose titration phase). Week 4 onwards, subjects will be maintained on maximum achieved dose until the end of the trial (dose maintenance pahe). During the titration phase, total dose will be increased by 10mg at each visit and by 5mg on the 4th day after each visit.
| Study group | Role | What they receive |
|---|---|---|
| Buspirone | Experimental | Buspirone administered in tablets twice daily titrated to a maximum daily dose of 60mg for 8 weeks. Receives: Drug: Buspirone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change From Baseline in Pediatric Anxiety Rating Scale (PARS)
The PARS is a clinician-rated scale to be used with parents and children. It consists of 57 items and has two sections: a symptom checklist (first 50 items) and severity items (last 7 items). The symptom checklist is used to determine the child's repertoire of symptoms during the past week. The 7 severity items are used to determine severity of symptoms and the PARS total score. The total score for the PARS is derived by summing the 7 severity items; total score ranges from 0 to 35, where higher scores indicate greater severity. The outcome reported reflects the change from baseline in PARS scores. When examining change from baseline, negative scores represent improvement (i.e., decrease in severity from baseline).
Measured: Baseline to week 8
Clinician-rated Clinical Global Impression-Anxiety-Improvement (CGI-Anxiety-I) Scores of Improved or Very Much Improved at Study Endpoint
The CGI-Anxiety-I is a clinician rated measure of anxiety improvement. Improvement scores range from 1 (very much improved) to 7 (very much worse). This outcome reports the number of participants who scored ≤2 (improved or very much) at study endpoint.
Measured: Week 8 (study endpoint)
Treatment Responder
Treatment responder is defined by a Clinician-rated Clinical Global Impression-Anxiety-Improvement (CGI-Anxiety-I) score ≤ 2 (improved or very much improved) and a ≥30% reduction on the Pediatric Anxiety Rating Scale (PARS) from baseline.
Measured: Week 8 (study endpoint)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 May 2013 (estimated)
- Study startJul 2013
- Primary completionDec 2024
- Study completionDec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Autism Spectrum DisordersStudies of the same condition, open and under way.
- More trials run by Massachusetts General HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 9 participants (actual)
Sponsor and investigators
- Lead sponsor
- Massachusetts General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gagan Joshi, Massachusetts General Hospital
- Investigators
- Gagan Joshi, MD, Principal investigator, Massachusetts General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01850355
- Sponsor's protocol ID
- 2013-P-000661
- Status last verified
- Feb 2025
- First submitted
- 22 Apr 2013
- Last updated
- 25 Feb 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-label Trial of Buspirone for the Treatment of Anxiety in Youth With Autism Spectrum Disorders
- ClinicalTrials.gov ID
- NCT01850355
- Acronym / sponsor ID
- 2013-P-000661
- Conditions
- Autism Spectrum Disorders, Anxiety
- Keywords
- Autism Spectrum Disorders, Anxiety, Children, Adolescents, Buspar, Buspirone, Pervasive Developmental Disorders
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 9 participants (actual)
- Lead sponsor
- Massachusetts General HospitalUniversity, hospital or other
- Study start
- Jul 2013 (actual)
- Primary completion
- Dec 2024 (actual)
- Study completion
- Dec 2024 (actual)
- First posted
- 9 May 2013 (estimated)
- Results
- Posted 25 Feb 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The main objective of this exploratory 8-week pilot study is to evaluate the safety and efficacy of buspirone for the treatment of anxiety in youth (ages 6-17 years) with autism spectrum disorders. The study results will be used to generate hypothesis for a larger randomized controlled clinical trials with explicit hypotheses and sufficient statistical power.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Buspirone | Experimental | Drug: BuspironeBuspirone administered in tablets twice daily titrated to a maximum daily dose of 60mg for 8 weeks. |
Who may qualify
- Ages
- 6 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- Male or female participants between 6 and 17 years of age
- Fulfills diagnosis of autism spectrum disorders by meeting DSM-IV-TR PDD diagnostic criteria of autistic disorder, Asperger's disorder, or PDD-NOS as established by clinical diagnostic interview
- Participants with a score of ≥13 on the Pediatric Anxiety Rating Scale (PARS)
- Participants with a score of ≥60 or more on the Anxiety/Depression subscale of CBCL and CGI-Anxiety severity of ≥ 4
- Subjects can be on psychotropic drugs if they have been on the medication for at least 4 weeks prior to initiating trial treatment and if they are stable, provided the medication is not listed in the Concomitant Medications section of the protocol.
Key exclusion criteria (15 listed)
- I.Q. < 70
- DSM-IV-TR PDD diagnoses of Rett's disorder, and childhood disintegrative disorder
- History of active seizure disorder (EEG suggestive of seizure activity and/or history of seizure in last 1 month)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BuspironeChildren with autism spectrum disorders will receive buspirone treatment for eight weeks. Buspirone will be titrated to the maximum daily dose during the first four weeks of the trial (dose titration phase). Week 4 onwards, subjects will be maintained on maximum achieved dose until the end of the trial (dose maintenance pahe). During the titration phase, total dose will be increased by 10mg at each visit and by 5mg on the 4th day after each visit. | Drug | Buspirone |
Primary outcome
Change From Baseline in Pediatric Anxiety Rating Scale (PARS)
Time frame: Baseline to week 8
The PARS is a clinician-rated scale to be used with parents and children. It consists of 57 items and has two sections: a symptom checklist (first 50 items) and severity items (last 7 items). The symptom checklist is used to determine the child's repertoire of symptoms during the past week. The 7 severity items are used to determine severity of symptoms and the PARS total score. The total score for the PARS is derived by summing the 7 severity items; total score ranges from 0 to 35, where higher scores indicate greater severity. The outcome reported reflects the change from baseline in PARS scores. When examining change from baseline, negative scores represent improvement (i.e., decrease in severity from baseline).
Clinician-rated Clinical Global Impression-Anxiety-Improvement (CGI-Anxiety-I) Scores of Improved or Very Much Improved at Study Endpoint
Time frame: Week 8 (study endpoint)
The CGI-Anxiety-I is a clinician rated measure of anxiety improvement. Improvement scores range from 1 (very much improved) to 7 (very much worse). This outcome reports the number of participants who scored ≤2 (improved or very much) at study endpoint.
Treatment Responder
Time frame: Week 8 (study endpoint)
Treatment responder is defined by a Clinician-rated Clinical Global Impression-Anxiety-Improvement (CGI-Anxiety-I) score ≤ 2 (improved or very much improved) and a ≥30% reduction on the Pediatric Anxiety Rating Scale (PARS) from baseline.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Feb 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gagan Joshi, MD principal investigator
Massachusetts General Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Buspirone in people with Autism Spectrum Disorders and Anxiety, run by Massachusetts General Hospital at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 25 Feb 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change From Baseline in Pediatric Anxiety Rating Scale (PARS) (time frame: Baseline to week 8). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Feb 2025.