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

Sponsor
Massachusetts General Hospital (Other)
Overall Status
Active, not recruiting
CT.gov ID
NCT01850355
Collaborator
(none)
9
1
1
113
0.1

Study Details

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

Condition or Disease Intervention/Treatment Phase
N/A

Study Design

Study Type:
Interventional
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 :
Jul 1, 2013
Anticipated Primary Completion Date :
Dec 1, 2022
Anticipated Study Completion Date :
Dec 1, 2022

Arms and Interventions

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

Primary Outcome Measures

  1. Reduction in Pediatric Anxiety Rating Scale (PARS) score [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 [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

Criteria

Ages Eligible for Study:
6 Years to 17 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Locations

Site City State Country Postal Code
1 Massachusetts General Hospital Boston Massachusetts United States 02114

Sponsors and Collaborators

  • Massachusetts General Hospital

Investigators

  • Principal Investigator: Gagan Joshi, MD, Massachusetts General Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
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
Last Update Posted:
Mar 31, 2022
Last Verified:
Mar 1, 2022

Study Results

No Results Posted as of Mar 31, 2022