Sertraline Study for 24-60 Month Old Children with Fragile X Syndrome

Sertraline Study – Clinical Trials

We are actively recruiting children diagnosed with FXS between 24-60 months old to participate in a groundbreaking study!

We have preliminary evidence that sertraline, a selective serotonin reuptake inhibitor (SSRI) is beneficial for langauge development in young children with FXS. It is our hope that this study will lead to a better understanding of the benefits of early treatment with sertraline for young children with FXS and inform future treatment and interventions.

Who can participate?

• Children between the ages of 24-60 months of age diagnosed with FXS (documentation by DNA testing).
• A reliable parent or caregiver who can report the side effects and communicate effectively with the research team for 6 months.

Exclusion Criteria

• Current or past SSRI treatment
• Other serious co-morbid medical disorders affecting brain function and behavior, including uncontrolled seizures.

What does it involve?

• 2 visits to the MIND Institute
• Collaborative assessments by MIND Institute FXS team Speech and Occupational therapists.
• Children will participate in cognitive, language, sensory and social assessments.
• Medical appointment(s) with Dr. Randi Hagerman and FXS team.
• Randomized assignment to liquid Sertraline or placebo with routine follow up by research team.

What are the benefits?

• Families will receive feedback on their child’s performance on the standardized tests that are part of the study.
• Results from this study will have the potential to positively influence the trajectory of development in FXS.

For more information please contact one of our research coordinators or visit the website below:

clinicaltrials.gov/show/NCT01474746