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A Trial of Sertraline in Young Children With Autism Spectrum Disorder

NCT02385799 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 58

Last updated 2019-10-22

Study results available
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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.

Conditions

Interventions

DRUG

Sertraline Liquid Placebo

Liquid placebo given in parallel to active medication

DRUG

Sertraline

Active medication

Sponsors & Collaborators

  • Health Resources and Services Administration (HRSA)

    collaborator FED

  • Randi J. Hagerman, MD

    lead OTHER

Principal Investigators

  • Randi J Hagerman, M.D. · UC Davis MIND Institute

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
24 Months
Max Age
72 Months
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-04-30
Primary Completion
2018-07-31
Completion
2018-07-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02385799 on ClinicalTrials.gov