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A Pilot Study of Buspirone for the Treatment of Anxiety in Youth With Autism Spectrum Disorders

Primary Purpose

Autism Spectrum Disorder, Anxiety

Status
Not yet recruiting
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Buspirone
Sponsored by
Massachusetts General Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Autism Spectrum Disorder focused on measuring Autism Spectrum Disorders, Anxiety, Pervasive Developmental Disorders, Buspar, Buspirone

Eligibility Criteria

6 Years - 17 Years (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Male or female participants between 6 and 17 years of age
  • DSM-5 ASD diagnostic criteria as established by clinical diagnostic interview
  • Participants with a score of ≥60 or more on the Anxiety/Depression subscale of CBCL
  • Subjects can be taking psychotropic medications 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, provided the medication is not listed in the Concomitant Medications section of the protocol.

Exclusion Criteria:

  • 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 or bipolar disorder
  • 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.

Sites / Locations

  • Massachusetts General Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Buspirone

Arm Description

Buspirone tablets will be administered twice daily, and will be titrated to a maximum daily dose of 60mg for 8 weeks.

Outcomes

Primary Outcome Measures

Reduction in Child and Adolescent Symptom Inventory-5-Anxiety (CASI-Anx) Score
The primary outcome measure of efficacy will be assessed by the reduction in anxiety symptom severity as measured by a change from baseline on the Child and Adolescent Symptom Inventory-5-Anxiety (CASI-Anx) scores. Responders are defined as those who demonstrate a >30% reduction on the CASI-Anx.

Secondary Outcome Measures

Full Information

First Posted
February 6, 2018
Last Updated
January 18, 2023
Sponsor
Massachusetts General Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT03432065
Brief Title
A Pilot Study of Buspirone for the Treatment of Anxiety in Youth With Autism Spectrum Disorders
Official Title
A Pilot Study of Buspirone for the Treatment of Anxiety in Youth With Autism Spectrum Disorders
Study Type
Interventional

2. Study Status

Record Verification Date
January 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
December 2023 (Anticipated)
Primary Completion Date
August 2024 (Anticipated)
Study Completion Date
August 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Massachusetts General Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
Yes
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 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, Anxiety
Keywords
Autism Spectrum Disorders, Anxiety, Pervasive Developmental Disorders, Buspar, Buspirone

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
15 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Buspirone
Arm Type
Experimental
Arm Description
Buspirone tablets will be administered twice daily, and will be titrated to a maximum daily dose of 60mg for 8 weeks.
Intervention Type
Drug
Intervention Name(s)
Buspirone
Intervention Description
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. During the titration phase, total dose will be increased by 10mg at each visit and by 5mg on the 4th day after each visit.
Primary Outcome Measure Information:
Title
Reduction in Child and Adolescent Symptom Inventory-5-Anxiety (CASI-Anx) Score
Description
The primary outcome measure of efficacy will be assessed by the reduction in anxiety symptom severity as measured by a change from baseline on the Child and Adolescent Symptom Inventory-5-Anxiety (CASI-Anx) scores. Responders are defined as those who demonstrate a >30% reduction on the CASI-Anx.
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 DSM-5 ASD diagnostic criteria as established by clinical diagnostic interview Participants with a score of ≥60 or more on the Anxiety/Depression subscale of CBCL Subjects can be taking psychotropic medications 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, provided the medication is not listed in the Concomitant Medications section of the protocol. Exclusion Criteria: 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 or bipolar disorder 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Chloe Hutt Vater, BA
Phone
617-724-7301
Email
chuttvater@mgh.harvard.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Atilla Ceranoglu, MD
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
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Chloe Hutt Vater, BA
Phone
617-724-7301
Email
chuttvater@mgh.harvard.edu

12. IPD Sharing Statement

Learn more about this trial

A Pilot Study of Buspirone for the Treatment of Anxiety in Youth With Autism Spectrum Disorders

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