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Purpose

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.

Conditions

Eligibility

Eligible Ages
Between 6 Years and 17 Years
Eligible Genders
All
Accepts Healthy Volunteers
No

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.

Study Design

Phase
N/A
Study Type
Interventional
Allocation
N/A
Intervention Model
Single Group Assignment
Primary Purpose
Treatment
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Buspirone 		Buspirone administered in tablets twice daily titrated to a maximum daily dose of 60mg for 8 weeks.
  • Drug: Buspirone
    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.

More Details

Status
Active, not recruiting
Sponsor
Massachusetts General Hospital

Study Contact

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.