A Trial of Sertraline in Young Children With Autism Spectrum Disorder

• Status: Completed
• Trial end date: 2018-07-01
• Target enrollment: 0
• Participant gender: All

Summary

This study is a control trial of sertraline (Zoloft) in children aged 2 to 5 years old inclusive with Autism Spectrum Disorder. The trial is six months long, and each participant will receive a series of tests at both the beginning and end of the study. The researchers hope to show improvements in language and social deficits.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Randi J. Hagerman, MD; University of California, Davis
• Collaborator: Health Resources and Services Administration (HRSA)
• Treatments: Sertraline

Criteria

Inclusion Criteria:

• Documentation of Autism Spectrum Disorder with Diagnostic and Statistical Manual for Mental Disorders-Fifth edition, criteria as well as a standardized autism assessment such as the Autism Diagnostic Observation Schedule or the Autism Diagnostic Interview-Revised.

• Subject between the ages of 24-72 months of age.

• A reliable parent or caregiver who can report the side effects and communicate effectively with the research team.

• Stable medications during the two months prior to enrollment.

• Currently receiving interventions in the community or school for Autism Spectrum Disorder

Exclusion Criteria:

• Current or past Selective Serotonin Reuptake Inhibitor treatment.

• Other serious co-morbid medical disorders affecting brain function and behavior, including uncontrolled seizures.