Clinical trial NCT03432065: 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
Overall status: WITHDRAWN
Phase: PHASE2
Conditions: Autism Spectrum Disorder
Anxiety
Keywords: Autism Spectrum Disorders
Anxiety
Pervasive Developmental Disorders
Buspar
Buspirone
Lead sponsor: Massachusetts General Hospital
Sponsor class: OTHER
First posted: 2018-02-13
Enrollment: 0
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 hypotheses for a larger randomized-controlled trial with explicit hypotheses and sufficient statistical power.


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.

Primary outcomes:
measure: Reduction in Child and Adolescent Symptom Inventory-5-Anxiety (CASI-Anx) Score
timeFrame: Baseline to 8 Weeks
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Massachusetts General Hospital
name: Atilla Ceranoglu, MD
role: PRINCIPAL_INVESTIGATOR
References: