Trial of Sertraline to Treat Children With Fragile X Syndrome
Information source: University of California, Davis
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Fragile X Syndrome
Intervention: Sertraline (Drug); Placebo (Drug)
Phase: Phase 2
Status: Active, not recruiting
Sponsored by: University of California, Davis Official(s) and/or principal investigator(s): Randi J Hagerman, MD, Principal Investigator, Affiliation: UC Davis MIND Institute Kathleen Angkustsiri, MD, Principal Investigator, Affiliation: UC Davis MIND Institute
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.
Clinical Details
Official title: A Controlled Trial of Sertraline in Young Children With Fragile X Syndrome
Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment
Primary outcome: Mullen Scales of Early LearningClinical Global Impression
Secondary outcome: Autism Diagnostic Observation ScheduleVisual Analog Scale Eye tracking Preschool Language Scale Sensory Processing Measure Sensory Profile Vineland Adaptive Behavior Scales, Second Edition (Vineland-II)
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 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.
Eligibility
Minimum age: 24 Months.
Maximum age: 68 Months.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- Fragile X Syndrome
Exclusion Criteria:
- 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
Locations and Contacts
UC Davis M.I.N.D. Institute, Sacramento, California 95817, United States
Additional Information
Starting date: January 2012
Last updated: August 12, 2015
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