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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT03432065
Recruitment Status : Recruiting
First Posted : February 13, 2018
Last Update Posted : October 4, 2018
Information provided by (Responsible Party):
Tolga A Ceranoglu, Massachusetts General Hospital

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.

Condition or disease Intervention/treatment Phase
Autism Spectrum Disorder Anxiety Drug: Buspirone Phase 2

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 15 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Pilot Study of Buspirone for the Treatment of Anxiety in Youth With Autism Spectrum Disorders
Estimated Study Start Date : October 2018
Estimated Primary Completion Date : August 2020
Estimated Study Completion Date : August 2020

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: Buspirone
Buspirone tablets will be administered twice daily, and will be 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. 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 Measures :
  1. Reduction in Child and Adolescent Symptom Inventory-5-Anxiety (CASI-Anx) Score [ Time Frame: Baseline to 8 Weeks ]
    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.

Information from the National Library of Medicine

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

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT03432065

Contact: Nina Dallenbach, BS 617-724-7079
Contact: Elizabeth Noyes, BA 617-726-4651

United States, Massachusetts
Massachusetts General Hospital Recruiting
Boston, Massachusetts, United States, 02114
Contact: Nina Dallenbach, BS    617-724-7079   
Contact: Elizabeth A Noyes, BA    617-726-4651   
Sponsors and Collaborators
Massachusetts General Hospital
Principal Investigator: Atilla Ceranoglu, MD Massachusetts General Hospital

Responsible Party: Tolga A Ceranoglu, Medical doctor, Massachusetts General Hospital Identifier: NCT03432065     History of Changes
Other Study ID Numbers: 2017-P-002731
First Posted: February 13, 2018    Key Record Dates
Last Update Posted: October 4, 2018
Last Verified: October 2018

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

Keywords provided by Tolga A Ceranoglu, Massachusetts General Hospital:
Autism Spectrum Disorders
Pervasive Developmental Disorders

Additional relevant MeSH terms:
Anxiety Disorders
Autistic Disorder
Autism Spectrum Disorder
Child Development Disorders, Pervasive
Pathologic Processes
Mental Disorders
Neurodevelopmental Disorders
Anti-Anxiety Agents
Tranquilizing Agents
Central Nervous System Depressants
Physiological Effects of Drugs
Psychotropic Drugs
Serotonin Receptor Agonists
Serotonin Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action