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An Open-Label Trial of Buspirone for the Treatment of Anxiety in Youth With Autism Spectrum Disorders

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ClinicalTrials.gov Identifier: NCT01850355
Recruitment Status : Active, not recruiting
First Posted : May 9, 2013
Last Update Posted : February 10, 2021
Sponsor:
Information provided by (Responsible Party):
Gagan Joshi, Massachusetts General Hospital

Study Description
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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 hypothesis for a larger randomized controlled clinical trials with explicit hypotheses and sufficient statistical power.

Condition or disease Intervention/treatment Phase
Autism Spectrum Disorders Anxiety Drug: Buspirone Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 9 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: An Open-label Trial of Buspirone for the Treatment of Anxiety in Youth With Autism Spectrum Disorders
Actual Study Start Date : July 2013
Estimated Primary Completion Date : December 2021
Estimated Study Completion Date : December 2021

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Arms and Interventions
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Arm Intervention/treatment
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.


Outcome Measures
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Primary Outcome Measures :
  1. Reduction in Pediatric Anxiety Rating Scale (PARS) score [ Time Frame: Baseline to 8 weeks ]
    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 PARS score.

  2. Clinical Global Impression-Anxiety (CGI-Anxiety) Improvement Score [ Time Frame: Baseline to 8 weeks ]
    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 sub scale.


Eligibility Criteria
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Ages Eligible for Study:   6 Years to 17 Years   (Child)
Sexes Eligible for Study:   All
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 ≥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.
Contacts and Locations
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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01850355


Locations
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United States, Massachusetts
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
Sponsors and Collaborators
Massachusetts General Hospital
Investigators
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Principal Investigator: Gagan Joshi, MD Massachusetts General Hospital
More Information
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Responsible Party: Gagan Joshi, Principal Investigator, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT01850355    
Other Study ID Numbers: 2013-P-000661
First Posted: May 9, 2013    Key Record Dates
Last Update Posted: February 10, 2021
Last Verified: February 2021
Keywords provided by Gagan Joshi, Massachusetts General Hospital:
Autism Spectrum Disorders
Anxiety
Children
Adolescents
 Buspar
Buspirone
Pervasive Developmental Disorders
Additional relevant MeSH terms:
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Disease
Anxiety Disorders
Autistic Disorder
Autism Spectrum Disorder
Child Development Disorders, Pervasive
Pathologic Processes
Mental Disorders
Neurodevelopmental Disorders
Buspirone
 Anti-Anxiety Agents
Tranquilizing Agents
Central Nervous System Depressants
Physiological Effects of Drugs
Psychotropic Drugs
Serotonin Receptor Agonists
Serotonin Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action