CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 57 enrolled
Drug / intervention
Sertraline +1 moredrug
Likely dose
Sertraline 20 mgfrom 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/NCT01474746
NCT01474746Phase 2Completed
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A Controlled Trial of Sertraline in Young Children With Fragile X Syndrome

Randi J. Hagerman, MD·interventional·Posted Nov 18, 2011·Updated Sep 25, 2017

In Brief

A Phase 2 clinical trial evaluating Sertraline and Placebo for Fragile X Syndrome. Completed, enrolled 57 participants across 1 site.

Detailed Summary

This study is a control trial of sertraline (Zoloft) in fragile X syndrome children aged 2 years to 5 years 8 months old. 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 a decrease in autistic symptoms.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsFragile X Syndrome
CountriesUnited States
Collaborators--

Timeline

Phase 2CompletedFinished
201220132014201520162017201820192020202120222023202420252026
First PostedNov 18, 2011
Enrollment StartJan 1, 2012
Primary CompletionAug 1, 2015
Study CompletionSep 1, 2015
TodayJul 2, 2026
Enrollment to primary: 3.6 yearsPosted 14.6 years ago

Interventions

Sertralinedrug

Liquid sertraline (20 mg/mL) will be dosed in an age-dependent manner. Participants aged 2-3 years of age will be given 2.5 mg (0.125 mL) of liquid sertraline once per day for a period of six months. Participants aged 4 years to 5 years 8 months will be given 5 mg (0.25 mL) of liquid sertraline once per day for a period of six months.

Placebodrug

The placebo will be dosed in an age-dependent manner. Participants aged 2-3 years of age will be given 2.5 mg (0.125 mL) of liquid placebo once per day for a period of six months. Participants aged 4 years to 5 years 8 months will be given 5 mg (0.25 mL) of liquid placebo once per day for a period of six months.