Clinical trial NCT01850355: An Open-Label Trial of Buspirone for the Treatment of Anxiety in Youth With Autism Spectrum Disorders
Official title: An Open-label Trial of Buspirone for the Treatment of Anxiety in Youth With Autism Spectrum Disorders
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Autism Spectrum Disorders
Anxiety
Keywords: Autism Spectrum Disorders
Anxiety
Children
Adolescents
Buspar
Buspirone
Pervasive Developmental Disorders
Lead sponsor: Massachusetts General Hospital
Sponsor class: OTHER
First posted: 2013-05-09
Enrollment: 9
Sex: ALL
Minimum age (years): 6
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


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 ≥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.

Primary outcomes:
measure: Change From Baseline in Pediatric Anxiety Rating Scale (PARS)
timeFrame: Baseline to week 8
measure: Clinician-rated Clinical Global Impression-Anxiety-Improvement (CGI-Anxiety-I) Scores of Improved or Very Much Improved at Study Endpoint
timeFrame: Week 8 (study endpoint)
measure: Treatment Responder
timeFrame: Week 8 (study endpoint)
Secondary outcomes:
Other outcomes:
Locations:
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
Study officials:
affiliation: Massachusetts General Hospital
name: Gagan Joshi, MD
role: PRINCIPAL_INVESTIGATOR
References: