An Open-Label Trial of Buspirone for the Treatment of Anxiety in Youth With Autism Spectrum Disorders
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| ClinicalTrials.gov Identifier: NCT01850355 |
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Recruitment Status :
Recruiting
First Posted : May 9, 2013
Last Update Posted : June 6, 2018
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Sponsor:
Massachusetts General Hospital
Information provided by (Responsible Party):
Gagan Joshi, Massachusetts General Hospital
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Brief 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. The study results will be used to generate hypothesis for a larger randomized controlled clinical trials with explicit hypotheses and sufficient statistical power.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Autism Spectrum Disorders Anxiety | Drug: Buspirone | Not Applicable |
| Study Type : | Interventional (Clinical Trial) |
| Estimated Enrollment : | 40 participants |
| Intervention Model: | Single Group Assignment |
| Masking: | None (Open Label) |
| Primary Purpose: | Treatment |
| Official Title: | An Open-label Trial of Buspirone for the Treatment of Anxiety in Youth With Autism Spectrum Disorders |
| Study Start Date : | July 2013 |
| Estimated Primary Completion Date : | April 2019 |
| Estimated Study Completion Date : | April 2019 |
Resource links provided by the National Library of Medicine
Genetics Home Reference related topics:
Autism spectrum disorder
| Arm | Intervention/treatment |
|---|---|
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Experimental: Buspirone
Buspirone administered in tablets twice daily titrated to a maximum daily dose of 60mg for 8 weeks.
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Drug: Buspirone
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. |
Primary Outcome Measures :
- Reduction in Pediatric Anxiety Rating Scale (PARS) score [ Time Frame: Baseline to 8 weeks ]Primary outcome measure of efficacy will be assessed by reduction in anxiety symptom severity as measured by change from baseline. Responders are defined as >/=30% reduction in PARS score.
- Clinical Global Impression-Anxiety (CGI-Anxiety) Improvement Score [ Time Frame: Baseline to 8 weeks ]Primary outcome measure of efficacy will be assessed by reduction in anxiety symptom severity as measured by Clinical Global Impression-Anxiety (CGI-Anxiety). Responders are defined as a score of </=2 on the improvement sub scale.
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| Ages Eligible for Study: | 6 Years to 17 Years (Child) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
- 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.
Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01850355
Contacts
| Contact: Babora Hoskova | 617-724-7301 | bhoskova@partners.org | |
| Contact: Alexa Pulli, BS | 617-726-4651 | apulli@mgh.harvard.edu |
Locations
| United States, Massachusetts | |
| Massachusetts General Hospital | Recruiting |
| Boston, Massachusetts, United States, 02114 | |
| Contact: Barbora Hoskova 617-724-7301 bhoskova@partners.org | |
| Contact: Alexa Pulli, BS 617-726-4651 apulli@partners.org | |
Sponsors and Collaborators
Massachusetts General Hospital
Investigators
| Principal Investigator: | Gagan Joshi, MD | Massachusetts General Hospital |
| Responsible Party: | Gagan Joshi, Principal Investigator, Massachusetts General Hospital |
| ClinicalTrials.gov Identifier: | NCT01850355 History of Changes |
| Other Study ID Numbers: |
2013-P-000661 |
| First Posted: | May 9, 2013 Key Record Dates |
| Last Update Posted: | June 6, 2018 |
| Last Verified: | June 2018 |
Keywords provided by Gagan Joshi, Massachusetts General Hospital:
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Autism Spectrum Disorders Anxiety Children Adolescents |
Buspar Buspirone Pervasive Developmental Disorders |
Additional relevant MeSH terms:
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Disease Anxiety Disorders Autistic Disorder Autism Spectrum Disorder Child Development Disorders, Pervasive Pathologic Processes Mental Disorders Neurodevelopmental Disorders Buspirone |
Anti-Anxiety Agents Tranquilizing Agents Central Nervous System Depressants Physiological Effects of Drugs Psychotropic Drugs Serotonin Receptor Agonists Serotonin Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action |