Back to resultsDouble-blind Trial of Buspirone for the Treatment of Anxiety in Youth With Autism Spectrum Disorders
Primary Purpose
Autism Spectrum Disorder (ASD)
Status
Withdrawn
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Buspirone
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Autism Spectrum Disorder (ASD) focused on measuring Buspirone, Buspar, Autism Spectrum Disorders, Pervasive Developmental Disorders, Children, Adolescents, Anxiety
Eligibility 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.
Sites / Locations
- Massachusetts General Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
Buspirone
Placebo
Arm Description
Outcomes
Primary Outcome Measures
Reduction in Pediatric Anxiety Rating Scale (PARS) Score
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
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").
Secondary Outcome Measures
Full Information
NCT ID
NCT01395953
First Posted
July 14, 2011
Last Updated
July 8, 2021
Sponsor
Massachusetts General Hospital
1. Study Identification
Unique Protocol Identification Number
NCT01395953
Brief Title
Double-blind Trial of Buspirone for the Treatment of Anxiety in Youth With Autism Spectrum Disorders
Official Title
Double-blind Trial of Buspirone for the Treatment of Anxiety in Youth With Autism Spectrum Disorders
Study Type
Interventional
2. Study Status
Record Verification Date
July 2021
Overall Recruitment Status
Withdrawn
Why Stopped
This study was withdrawn due to competing research interests and slow recruitment.
Study Start Date
November 2011 (undefined)
Primary Completion Date
July 2013 (Actual)
Study Completion Date
July 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Massachusetts General Hospital
4. Oversight
Data Monitoring Committee
No
5. Study Description
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 hypotheses for a larger randomized controlled clinical trial with explicit hypotheses and sufficient statistical power.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Autism Spectrum Disorder (ASD)
Keywords
Buspirone, Buspar, Autism Spectrum Disorders, Pervasive Developmental Disorders, Children, Adolescents, Anxiety
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Buspirone
Arm Type
Active Comparator
Arm Title
Placebo
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
Buspirone
Other Intervention Name(s)
Buspar
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
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.
Primary Outcome Measure Information:
Title
Reduction in Pediatric Anxiety Rating Scale (PARS) Score
Description
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).
Time Frame
baseline to 8 weeks
Title
Clinical Global Impression-Anxiety (CGI-Anxiety) Improvement Score
Description
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").
Time Frame
baseline to 8 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
6 Years
Maximum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gagan Joshi, M.D.
Organizational Affiliation
Massachusetts General Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Massachusetts General Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Double-blind Trial of Buspirone for the Treatment of Anxiety in Youth With Autism Spectrum Disorders
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