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

This study has been terminated.
(This study was terminated due to competing research interests and slow recruitment.)
Sponsor:
Information provided by (Responsible Party):
Gagan Joshi, MD, Massachusetts General Hospital
ClinicalTrials.gov Identifier:
NCT01395953
First received: July 14, 2011
Last updated: September 6, 2013
Last verified: September 2013
  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 hypotheses for a larger randomized controlled clinical trial with explicit hypotheses and sufficient statistical power.


Condition Intervention Phase
Autism Spectrum Disorder (ASD)
Drug: Buspirone
Drug: Placebo
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: Double-blind Trial of Buspirone for the Treatment of Anxiety in Youth With Autism Spectrum Disorders

Resource links provided by NLM:


Further study details as provided by Massachusetts General Hospital:

Primary Outcome Measures:
  • Reduction in Pediatric Anxiety Rating Scale (PARS) Score [ Time Frame: baseline to 8 weeks ] [ Designated as safety issue: No ]
    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 the Pediatric Anxiety Rating Scale (PARS).

  • Clinical Global Impression-Anxiety (CGI-Anxiety) Improvement Score [ Time Frame: baseline to 8 weeks ] [ Designated as safety issue: No ]
    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 subscale (i.e., "much" or "very much improved").


Enrollment: 2
Study Start Date: November 2011
Study Completion Date: July 2013
Primary Completion Date: July 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Buspirone Drug: Buspirone
Children with Autism Spectrum Disorders will receive buspirone or matched placebo. 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 till the end of the trial (dose maintenance phase). During the titration phase total dose of buspirone will be increased at each visit by 5mg and on the 4th day after each visit by 5mg.
Other Name: Buspar
Placebo Comparator: Placebo Drug: Placebo
Children with Autism Spectrum Disorders will receive buspirone or matched placebo. 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 till the end of the trial (dose maintenance phase). During the titration phase total dose of buspirone will be increased at each visit by 5mg and on the 4th day after each visit by 5mg.

  Eligibility

Ages Eligible for Study:   6 Years to 17 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01395953

Locations
United States, Massachusetts
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
Sponsors and Collaborators
Massachusetts General Hospital
Investigators
Principal Investigator: Gagan Joshi, M.D. Massachusetts General Hospital
  More Information

No publications provided

Responsible Party: Gagan Joshi, MD, Assistant Professor of Psychiatry, Harvard University, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT01395953     History of Changes
Other Study ID Numbers: 2011-P-000703
Study First Received: July 14, 2011
Last Updated: September 6, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Massachusetts General Hospital:
Buspirone
Buspar
Autism Spectrum Disorders
Pervasive Developmental Disorders
Children
Adolescents
Anxiety

Additional relevant MeSH terms:
Autistic Disorder
Disease
Child Development Disorders, Pervasive
Mental Disorders Diagnosed in Childhood
Mental Disorders
Pathologic Processes
Buspirone
Anti-Anxiety Agents
Tranquilizing Agents
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Psychotropic Drugs
Serotonin Receptor Agonists
Serotonin Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on October 01, 2014