Experimental medicine treatment, Sertraline (Zoloft) in Young Children With Autism Spectrum Disorder

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"Study of Experimental medicine for possible improvement for children with autism spectrum disorders (ASD)"
Age:
2 to 6 years old
Gender:
Any
Healthy Volunteers:
No
Keywords:
Autism Spectrum Disorder, autism, children
Type:
Drug study, Phase 2
Investigator:
Description
This study is a control trial of sertraline (Zoloft) in children aged 2 to 5 years old with Autism Spectrum Disorder. 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, and determine if sertraline is helpful for their language, development, and behavior.
This study requires
Pre-questionaire/medical exam/blood draw
Experimental medication (Sertraline or placebo)
Questionaire
Post-questionaire/medical exam/blood draw
Who can participate?
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.
Resources
Schedule
Study duration and period
6 months
Recruitment period
From Nov. 25, 2014
Location
UC Davis MIND Institute
2825 50th Street
Sacramento, CA 95817
Contact
Laura Axelrod Potter
Research Topic
Conditions:
  • Neurodevelopmental Disorder > Autism

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