CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 58 enrolled
Drug / intervention
Sertraline Liquid Placebo +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02385799
NCT02385799Phase 2Completed
CompareCT.gov

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

Randi J. Hagerman, MD·interventional·Posted Mar 11, 2015·Updated Oct 22, 2019

In Brief

A Phase 2 clinical trial evaluating Sertraline Liquid Placebo and Sertraline for Autism Spectrum Disorder. Completed, enrolled 58 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAutism Spectrum Disorder
CountriesUnited States
CollaboratorsHealth Resources and Services Administration (HRSA)

Timeline

Phase 2CompletedFinished
201520162017201820192020202120222023202420252026
First PostedMar 11, 2015
Enrollment StartApr 1, 2015
Primary CompletionJul 1, 2018
TodayJul 2, 2026
Enrollment to primary: 3.3 yearsPosted 11.3 years ago

Interventions

Sertraline Liquid Placebodrug

Liquid placebo given in parallel to active medication

Sertralinedrug

Active medication