Trial of Sertraline to Treat Children With Fragile X Syndrome

Completed · Phase 2 · Has a placebo group

Conditions studied: Fragile X Syndrome

In brief

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.

Key facts

Study ID

NCT01474746

Run by

Randi J. Hagerman, MD

People needed

57

Starts

2012-01-01

Expected to finish

2015-09-01

Last updated by the study team

2017-09-25

Who can join

Age: 2 and older, up to 6. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Fragile X Syndrome

You may not qualify if…

• 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

Where it is running

• UC Davis M.I.N.D. Institute — Sacramento, California, United States

Full record on ClinicalTrials.gov

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