A Trial of Sertraline in Young Children With Autism Spectrum Disorder

Conditions:Neurology, Psychiatric, Autism
Therapuetic Areas:Neurology, Psychiatry / Psychology
Age Range:Any
Start Date:April 2015
End Date:July 2018

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A Controlled Trial of Sertraline in Young Children With Autism Spectrum Disorder

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.

This is a single center study and the UC Davis MIND Institute for Autism Spectrum Disorder
(ASD) patients aged between 2 years and 5 years old inclusive funded by the Health Resources
and Services Administration (HRSA). It is a double-blind control trial of sertraline
(Zoloft), an anti-depressant typically used in the treatment of depression,
obsessive-compulsive disorder, panic disorder, and other conditions. The researchers are
investigating the use of this selective serotonin reuptake inhibitor (SSRI) in ASD because a
retrospective study has shown significant improvements in language and social deficits. There
is also emerging evidence regarding the stimulation of brain-derived neurotrophic factor
(BDNF) and the stimulation of neurogenesis when an SSRI is given early on in the development
of animal models of Down syndrome. The researchers hope to see improvements in language
stimulation, social gaze and social reciprocity, spatial attention, and a decrease in
autistic behaviors.

The aim of this study is to carry out a double-blind placebo controlled trial of sertraline
in children with ASD who are between the ages of 2 years and 5 years old inclusive. At
baseline, the researchers will assess behavioral and cognitive development. Each participant
will be involved in this trial for a period of six months. This will include three visits to
the UC Davis MIND Institute and eight phone calls. The researchers will also assess the side
effects of the sertraline treatment throughout the study.

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

- 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

Exclusion Criteria:

- Current or past Selective Serotonin Reuptake Inhibitor treatment.

- Other serious co-morbid medical disorders affecting brain function and behavior,
including uncontrolled seizures.
We found this trial at
Sacramento, California 95817
Principal Investigator: Randi J Hagerman, M.D.
Phone: 916-703-0471
Sacramento, CA
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