A Trial of Sertraline in Young Children With Autism Spectrum Disorder

Completed · Phase 2 · Has a placebo group

Conditions studied: Autism Spectrum Disorder

In brief

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.

Key facts

Study ID

NCT02385799

Run by

Randi J. Hagerman, MD

People needed

58

Starts

2015-04-01

Expected to finish

2018-07-01

Last updated by the study team

2019-10-22

Who can join

Age: 2 and older, up to 6. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• Current or past Selective Serotonin Reuptake Inhibitor treatment.
• Other serious co-morbid medical disorders affecting brain function and behavior, including uncontrolled seizures.

Where it is running

• UC Davis MIND Institute — Sacramento, California, United States

Full record on ClinicalTrials.gov

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