An Open-Label Trial of Buspirone for the Treatment of Anxiety in Youth With Autism Spectrum Disorders
Verified September 2014 by Massachusetts General Hospital
Information provided by (Responsible Party):
Gagan Joshi, MD, Massachusetts General Hospital
First received: April 22, 2013
Last updated: September 17, 2014
Last verified: September 2014
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.
Autism Spectrum Disorders
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
||An Open-label Trial of Buspirone for the Treatment of Anxiety in Youth With Autism Spectrum Disorders
Primary Outcome Measures:
- Reduction in Pediatric Anxiety Rating Scale (PARS) score [ Time Frame: Baseline to 8 weeks ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: No ]
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.
| Estimated Enrollment:
| Study Start Date:
| Estimated Study Completion Date:
| Estimated Primary Completion Date:
||April 2016 (Final data collection date for primary outcome measure)
Buspirone administered in tablets twice daily titrated to a maximum daily dose of 60mg for 8 weeks.
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.
|Ages Eligible for Study:
||6 Years to 17 Years
|Genders Eligible for Study:
|Accepts Healthy Volunteers:
- 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
- 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.
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For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01850355
Massachusetts General Hospital
||Gagan Joshi, MD
||Massachusetts General Hospital
No publications provided
||Gagan Joshi, MD, Principal Investigator, Massachusetts General Hospital
History of Changes
|Other Study ID Numbers:
|Study First Received:
||April 22, 2013
||September 17, 2014
||United States: Food and Drug Administration
Keywords provided by Massachusetts General Hospital:
Autism Spectrum Disorders
Pervasive Developmental Disorders
Additional relevant MeSH terms:
ClinicalTrials.gov processed this record on September 30, 2014
Child Development Disorders, Pervasive
Mental Disorders Diagnosed in Childhood
Central Nervous System Depressants
Physiological Effects of Drugs
Central Nervous System Agents
Serotonin Receptor Agonists
Molecular Mechanisms of Pharmacological Action