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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 Learning

Clinical Global Impression

Secondary outcome:

Autism Diagnostic Observation Schedule

Visual 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

Page last updated: August 23, 2015

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