An Open-Label Trial of Buspirone for the Treatment of Anxiety in Youth With Autism Spectrum Disorders

Study Overview
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Brief Summary
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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.

Official Title
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An Open-label Trial of Buspirone for the Treatment of Anxiety in Youth With Autism Spectrum Disorders

Conditions
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Autism Spectrum Disorders, Anxiety

Intervention / Treatment
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* Drug: Buspirone


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 6 Years
Maximum Age: 17 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Buspirone<br>Buspirone administered in tablets twice daily titrated to a maximum daily dose of 60mg for 8 weeks. | Drug: Buspirone<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Reduction in Pediatric Anxiety Rating Scale (PARS) score | 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. | Baseline to 8 weeks | 
| Clinical Global Impression-Anxiety (CGI-Anxiety) Improvement Score | 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. | Baseline to 8 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Autism Spectrum Disorders, Anxiety, Children, Adolescents, Buspar, Buspirone, Pervasive Developmental Disorders