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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 : Recruiting
First Posted : May 9, 2013
Last Update Posted : June 6, 2018
Sponsor:
Information provided by (Responsible Party):
Gagan Joshi, Massachusetts General Hospital

April 22, 2013
May 9, 2013
June 6, 2018
July 2013
April 2019   (Final data collection date for primary outcome measure)
  • 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.
  • 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.
Same as current
Complete list of historical versions of study NCT01850355 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
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An Open-Label Trial of Buspirone for the Treatment of Anxiety in Youth With Autism Spectrum Disorders
An Open-label Trial of Buspirone for the Treatment of Anxiety in Youth With Autism Spectrum Disorders
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.
Not Provided
Interventional
Not Applicable
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
  • Autism Spectrum Disorders
  • Anxiety
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.
Experimental: Buspirone
Buspirone administered in tablets twice daily titrated to a maximum daily dose of 60mg for 8 weeks.
Intervention: Drug: Buspirone
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
40
Same as current
April 2019
April 2019   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: All
6 Years to 17 Years   (Child)
No
Contact: Babora Hoskova 617-724-7301 bhoskova@partners.org
Contact: Alexa Pulli, BS 617-726-4651 apulli@mgh.harvard.edu
United States
 
 
NCT01850355
2013-P-000661
No
Not Provided
Not Provided
Gagan Joshi, Massachusetts General Hospital
Massachusetts General Hospital
Not Provided
Principal Investigator: Gagan Joshi, MD Massachusetts General Hospital
Massachusetts General Hospital
June 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP