Clinical Trial: Trial of Sertraline to Treat Children With Fragile X Syndrome

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: A Controlled Trial of Sertraline in Young Children With Fragile X Syndrome

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 tests at both the beginning and end of the study. The researchers hope to show improvements in language and a decrease in autistic symptoms.

Detailed Summary:

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 Administration (HRSA). It is a double-blind control trial of sertraline (Zoloft), an anti-depressant typically used in the treatment of depression, obsessive-compulsive disorder, panic disorder, and other conditions. The researchers are investigating the use of this selective serotonin reuptake inhibitor (SSRI) in FXS because a retrospective study has shown significant improvements in language and decreases in autistic behavior. There is also emerging evidence regarding the stimulation of brain-derived neurotrophic factor (BDNF) and the stimulation of neurogenesis when an SSRI is given early on in the development of animal models of Down syndrome. The researchers hope to see improvements in language stimulation, social gaze and social reciprocity, spatial attention, and a decrease in autistic behaviors.

The aim of this study is to carry out a double-blind placebo controlled trial of sertraline in children with FXS who are between the ages of 2 years and 5 years, 8 months old. At baseline, the researchers will assess behavioral and cognitive development. These children will be treated for six months with either sertraline or placebo. At the end of the six months, the researchers assess the same behavioral and cognitive measures as at the beginning of the study. The researchers will also assess the side effects of the sertraline treatment throughout the study.


Sponsor: University of California, Davis

Current Primary Outcome:

  • Mullen Scales of Early Learning [ Time Frame: Baseline and six months. ]
    The Mullen Scales of Early Learning is a cognitive test to measure cognitive ability and language development.
  • Clinical Global Impression [ Time Frame: Baseline and six months. ]
    The Clinical Global Impression will be used to measure the overall behavioral change of an individual.


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Autism Diagnostic Observation Schedule [ Time Frame: Baseline and six months. ]
    The Autism Diagnostic Observation Schedule assess and diagnoses autism and pervasive developmental disorder across ages, developmental levels, and language skills.
  • Visual Analog Scale [ Time Frame: Baseline and six months. ]
    The Visual Analog Scale will be used to measure the severity of specific behavioral symptoms chosen by the caregiver(s).
  • Eye tracking [ Time Frame: Baseline and six months. ]
    There are several eye tracking measures, each intended to measure different outcomes including social gaze, social reciprocity, and attention.
  • Preschool Language Scale [ Time Frame: Baseline and six months. ]
    The Preschool Language Scale is designed to measure language comprehension and communication in young children.
  • Sensory Processing Measure [ Time Frame: Baseline and six months ]
    The Sensory Processing Measure is a questionnaire that will be used to measure specific problems, including under- and over-responsiveness, sensory-seeking behavior, and perceptual problems
  • Sensory Profile [ Time Frame: Baseline and six months ]
    The Sensory Profile is designed to measure sensory-related difficulties.
  • Vineland Adaptive Behavior Scales, Second Edition (Vineland-II) [ Time Frame: Baseline and six months ]
    The Vineland-II measures the personal and social skills of individuals from birth through adulthood.


Original Secondary Outcome:

  • Autism Diagnostic Observation Schedule [ Time Frame: Baseline and six months. ]
    The Autism Diagnostic Observation Schedule assess and diagnoses autism and pervasive developmental disorder across ages, developmental levels, and language skills.
  • Visual Analog Scale [ Time Frame: Baseline and six months. ]
    The Visual Analog Scale will be used to measure the severity of specific behavioral symptoms of autism.
  • Eye tracking [ Time Frame: Baseline and six months. ]
    There are several eye tracking measures, each intended to measure different outcomes including social gaze, social reciprocity, and attention.
  • Preschool Language Scale [ Time Frame: Baseline and six months. ]
    The Preschool Language Scale is designed to measure language comprehension and communication in young children.


Information By: University of California, Davis

Dates:
Date Received: November 10, 2011
Date Started: January 2012
Date Completion:
Last Updated: January 26, 2016
Last Verified: January 2016