Trial record 2 of 4 for:
buspirone autism
Double-blind Trial of Buspirone for the Treatment of Anxiety in Youth With Autism Spectrum Disorders
This study is currently recruiting participants.
Verified May 2013 by Massachusetts General Hospital
Sponsor:
Massachusetts General Hospital
Information provided by (Responsible Party):
Gagan Joshi, MD, Massachusetts General Hospital
ClinicalTrials.gov Identifier:
NCT01395953
First received: July 14, 2011
Last updated: May 7, 2013
Last verified: May 2013
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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 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").
| Estimated Enrollment: | 60 |
| Study Start Date: | November 2011 |
| Estimated Study Completion Date: | September 2016 |
| Estimated Primary Completion Date: | September 2016 (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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01395953
Contacts
| Contact: Katie McDermott, BS | 617-726-4651 | kmmcdermott@partners.org |
Locations
| United States, Massachusetts | |
| Massachusetts General Hospital | Recruiting |
| Boston, Massachusetts, United States, 02114 | |
| Principal Investigator: Gagan Joshi, M.D. | |
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: | May 7, 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 Buspirone Anxiety Disorders Child Development Disorders, Pervasive Mental Disorders Mental Disorders Diagnosed in Childhood Serotonin Receptor Agonists Serotonin Agents Neurotransmitter Agents |
Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Physiological Effects of Drugs Anti-Anxiety Agents Tranquilizing Agents Central Nervous System Depressants Central Nervous System Agents Therapeutic Uses Psychotropic Drugs |
ClinicalTrials.gov processed this record on June 17, 2013