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Double-blind Trial of Buspirone for the Treatment of Anxiety in Youth With Autism Spectrum Disorders

Information source: Massachusetts General Hospital
ClinicalTrials.gov processed this data on August 20, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Autism Spectrum Disorder (ASD)

Intervention: Buspirone (Drug); Placebo (Drug)

Phase: Phase 2

Status: Withdrawn

Sponsored by: Massachusetts General Hospital

Official(s) and/or principal investigator(s):
Gagan Joshi, M.D., Principal Investigator, Affiliation: Massachusetts General Hospital

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.

Clinical Details

Official title: Double-blind Trial of Buspirone for the Treatment of Anxiety in Youth With Autism Spectrum Disorders

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Primary outcome:

Reduction in Pediatric Anxiety Rating Scale (PARS) Score

Clinical Global Impression-Anxiety (CGI-Anxiety) Improvement Score

Eligibility

Minimum age: 6 Years. Maximum age: 17 Years. Gender(s): Both.

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.

Locations and Contacts

Massachusetts General Hospital, Boston, Massachusetts 02114, United States
Additional Information

Starting date: November 2011
Last updated: April 6, 2015

Page last updated: August 20, 2015

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