Clinical trial NCT01395953: Double-blind Trial of Buspirone for the Treatment of Anxiety in Youth With Autism Spectrum Disorders
Official title: Double-blind Trial of Buspirone for the Treatment of Anxiety in Youth With Autism Spectrum Disorders
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE2
Conditions: Autism Spectrum Disorder (ASD)
Keywords: Buspirone
Buspar
Autism Spectrum Disorders
Pervasive Developmental Disorders
Children
Adolescents
Anxiety
Lead sponsor: Massachusetts General Hospital
Sponsor class: OTHER
First posted: 2011-07-18
Enrollment: 0
Sex: ALL
Minimum age (years): 6
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 hypotheses for a larger randomized controlled clinical trial with explicit hypotheses and sufficient statistical power.


Eligibility 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 ≥60 on the Anxiety/Depression subscale of Child Behavior Checklist (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 study treatment and if they are on a stable dose.
* 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:

* Mental retardation (I.Q. \<70)
* DSM-IV-TR PDD diagnosis 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.
* History of substance abuse (except nicotine of caffeine) within past 3 months or urine drug screen positive for substances of abuse.
* Any other concomitant medication with primary central nervous system activity other than stable regimens for \>2 weeks.
* A non-responder or history of intolerance to buspirone, after treatment at an adequate dose and duration as determined by the clinician.

Primary outcomes:
measure: Reduction in Pediatric Anxiety Rating Scale (PARS) Score
timeFrame: baseline to 8 weeks
measure: Clinical Global Impression-Anxiety (CGI-Anxiety) Improvement Score
timeFrame: baseline to 8 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
Study officials:
affiliation: Massachusetts General Hospital
name: Gagan Joshi, M.D.
role: PRINCIPAL_INVESTIGATOR
References: