Status:

COMPLETED

Trial of Sertraline to Treat Children With Fragile X Syndrome

Lead Sponsor:

Randi J. Hagerman, MD

Conditions:

Fragile X Syndrome

Eligibility:

All Genders

24-68 years

Phase:

PHASE2

Brief 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 te...

Detailed Description

This is a single center study and the UC Davis MIND Institute for fragile X syndrome (FXS) patients aged between 2 years and 5 years, 8 months old funded by the Health Resources and Services Administr...

Eligibility Criteria

Inclusion

  • Fragile X Syndrome

Exclusion

  • Current or past SSRI treatment
  • Current or past MAOI (monoamine oxidase inhibitor ) treatment
  • Serious co-morbid medical disorder affecting brain function and behavior (not including fragile X syndrome).
  • Uncontrolled seizure disorder or epilepsy
  • Bipolar disorder
  • Latex allergies

Key Trial Info

Start Date :

January 1 2012

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

September 1 2015

Estimated Enrollment :

57 Patients enrolled

Trial Details

Trial ID

NCT01474746

Start Date

January 1 2012

End Date

September 1 2015

Last Update

September 25 2017

Active Locations (1)

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1

UC Davis M.I.N.D. Institute

Sacramento, California, United States, 95817