Expired Study
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Boston, Massachusetts 02114


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.


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 Contact:

Principal Investigator
Gagan Joshi, M.D.
Massachusetts General Hospital

Backup Contact:


Location Contact:

Boston, Massachusetts 02114
United States

There is no listed contact information for this specific location.

Site Status: N/A

Data Source: ClinicalTrials.gov

Date Processed: August 31, 2019

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