Double-blind Trial of Buspirone for the Treatment of Anxiety in Youth With Autism Spectrum Disorders

NCT01395953 | Withdrawn Phase 2

• 1 other identifier: 2011-P-000703
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Autism Spectrum Disorder (ASD)

Keywords

Buspirone; Buspar; Autism Spectrum Disorders; Pervasive Developmental Disorders; Children; Adolescents; Anxiety

Outcome Measures

Primary Outcomes (2)

• 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).

  baseline to 8 weeks

• 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").

  baseline to 8 weeks

Study Arms (2)

Buspirone

ACTIVE COMPARATOR

Drug: Buspirone

Placebo

PLACEBO COMPARATOR

Drug: Placebo

Interventions

Buspirone DRUG

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.

Also known as: Buspar

Buspirone

Placebo DRUG

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.

Placebo

Eligibility Criteria

• Age: 6 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Massachusetts General Hospital: lead

Study Sites (1)

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

MeSH Terms

Conditions

Autism Spectrum Disorder; Child Development Disorders, Pervasive; Anxiety Disorders

Interventions

Buspirone

Condition Hierarchy (Ancestors)

Neurodevelopmental Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Spiro Compounds; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Piperazines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Pyrimidines; Polycyclic Compounds

Study Officials

• Gagan Joshi, M.D.

  Massachusetts General Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Psychiatry, Harvard University

Study Record Dates

• First Submitted: July 14, 2011
• First Posted: July 18, 2011
• Study Start: November 1, 2011
• Primary Completion: July 1, 2013
• Study Completion: July 1, 2013
• Last Updated: June 28, 2024

Record last verified: 2024-06

Locations

US (1)