Autism Spectrum DisorderPhase 2NCT03432065
A Pilot Study of Buspirone for the Treatment of Anxiety in Youth with Autism Spectrum Disorders
A Phase 2 study testing Buspirone in people with Autism Spectrum Disorder and Anxiety, run by Massachusetts General Hospital.
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 Disorder, 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
- 0 participants
- Where
- No sites listed yet
- Study dates
- Dec 2024to Aug 2025
- Phase
- Phase 2
- Are there results?
- None posted in the registry
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
- DSM-5 ASD diagnostic criteria as established by clinical diagnostic interview
- Participants with a score of ≥60 or more on the Anxiety/Depression subscale of CBCL
- Subjects can be taking psychotropic medications if they have been on the medication for at least 4 weeks prior to initiating study treatment and if they are on a stable dose, provided the medication is not listed in the Concomitant Medications section of the protocol.
Who cannot join
- 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
- Uncorrected hypothyroidism or hyperthyroidism
- Clinically significant abnormalities on ECG (e.g., QT prolongation, arrhythmia)
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- 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.
About this study
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 hypotheses for a larger randomized-controlled trial with explicit hypotheses and sufficient statistical power.
- Conditions
- Autism Spectrum Disorder, Anxiety
- Being tested
- Buspirone
- Keywords
- Autism Spectrum Disorders, Anxiety, Pervasive Developmental Disorders, Buspar, Buspirone
- 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. 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 tablets will be administered twice daily, and will be 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.
Reduction in Child and Adolescent Symptom Inventory-5-Anxiety (CASI-Anx) Score
The primary outcome measure of efficacy will be assessed by the reduction in anxiety symptom severity as measured by a change from baseline on the Child and Adolescent Symptom Inventory-5-Anxiety (CASI-Anx) scores. Responders are defined as those who demonstrate a >30% reduction on the CASI-Anx.
Measured: Baseline to 8 Weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Feb 2018
- Study startDec 2024 (estimated)
- Primary completionAug 2025 (estimated)
- Study completionAug 2025 (estimated)
Why it stopped: This study was withdrawn due to competing research interests and slow recruitment.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Autism Spectrum DisorderStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Massachusetts General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Tolga A Ceranoglu, Massachusetts General Hospital
- Investigators
- Atilla Ceranoglu, MD, Principal investigator, Massachusetts General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03432065
- Sponsor's protocol ID
- 2017-P-002731
- Status last verified
- Sep 2024
- First submitted
- 6 Feb 2018
- Last updated
- 26 Sep 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Study of Buspirone for the Treatment of Anxiety in Youth with Autism Spectrum Disorders
- ClinicalTrials.gov ID
- NCT03432065
- Acronym / sponsor ID
- 2017-P-002731
- Conditions
- Autism Spectrum Disorder, Anxiety
- Keywords
- Autism Spectrum Disorders, Anxiety, Pervasive Developmental Disorders, Buspar, Buspirone
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: This study was withdrawn due to competing research interests and slow recruitment.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Massachusetts General HospitalUniversity, hospital or other
- Study start
- Dec 2024 (estimated)
- Primary completion
- Aug 2025 (estimated)
- Study completion
- Aug 2025 (estimated)
- First posted
- 13 Feb 2018 (actual)
- Results
- Not posted in the source record
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 hypotheses for a larger randomized-controlled trial 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 tablets will be administered twice daily, and will be 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 (4 listed)
- Male or female participants between 6 and 17 years of age
- DSM-5 ASD diagnostic criteria as established by clinical diagnostic interview
- Participants with a score of ≥60 or more on the Anxiety/Depression subscale of CBCL
- Subjects can be taking psychotropic medications if they have been on the medication for at least 4 weeks prior to initiating study treatment and if they are on a stable dose, provided the medication is not listed in the Concomitant Medications section of the protocol.
Key exclusion criteria (13 listed)
- 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
- Uncorrected hypothyroidism or hyperthyroidism
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. 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
Reduction in Child and Adolescent Symptom Inventory-5-Anxiety (CASI-Anx) Score
Time frame: Baseline to 8 Weeks
The primary outcome measure of efficacy will be assessed by the reduction in anxiety symptom severity as measured by a change from baseline on the Child and Adolescent Symptom Inventory-5-Anxiety (CASI-Anx) scores. Responders are defined as those who demonstrate a >30% reduction on the CASI-Anx.
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Sep 2024.
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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.
Atilla Ceranoglu, MD principal investigator
Massachusetts General Hospital
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Buspirone in people with Autism Spectrum Disorder and Anxiety, run by Massachusetts General Hospital.
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 4 inclusion and 13 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: withdrawn, as of the sponsor's last update on 26 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.
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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
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?
Reduction in Child and Adolescent Symptom Inventory-5-Anxiety (CASI-Anx) Score (time frame: Baseline to 8 Weeks). 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 26 Sep 2024.