Trial of Sertraline to Treat Children With Fragile X Syndrome
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.
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
|Official Title:||A Controlled Trial of Sertraline in Young Children With Fragile X Syndrome|
- Mullen Scales of Early Learning [ Time Frame: Baseline and six months. ] [ Designated as safety issue: No ]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. ] [ Designated as safety issue: No ]The Clinical Global Impression will be used to measure the overall behavioral change of an individual.
- Autism Diagnostic Observation Schedule [ Time Frame: Baseline and six months. ] [ Designated as safety issue: No ]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. ] [ Designated as safety issue: No ]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. ] [ Designated as safety issue: No ]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. ] [ Designated as safety issue: No ]The Preschool Language Scale is designed to measure language comprehension and communication in young children.
- Sensory Processing Measure [ Time Frame: Baseline and six months ] [ Designated as safety issue: No ]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 ] [ Designated as safety issue: No ]The Sensory Profile is designed to measure sensory-related difficulties.
|Study Start Date:||January 2012|
|Estimated Study Completion Date:||December 2014|
|Estimated Primary Completion Date:||July 2014 (Final data collection date for primary outcome measure)|
Placebo Comparator: Placebo
This arm will undergo identical treatment as the experimental group, with the exception of the active agent (sertraline). This group will be placed on a placebo.
The placebo will be dosed in an age depended manner. Participants aged 2-3 years of age will be given 2.5 mg of liquid placebo once per day for a period of six months. Participants aged 4 years to 5 years 8 months will be given 5 mg of liquid placebo once per day for a period of six months.
This arm will undergo identical treatment as the placebo group. This group will be placed on a the active agent.
Liquid sertraline (20 mg/cc) will be dosed in an age depended manner. Participants aged 2-3 years of age will be given 2.5 mg of liquid sertraline once per day for a period of six months. Participants aged 4 years to 5 years 8 months will be given 5 mg of liquid sertraline once per day for a period of six months.
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.
|Contact: Tasleem Chechi, BS||(916) firstname.lastname@example.org|
|Contact: Jonathan Polussa, BS||(916) email@example.com|
|United States, California|
|UC Davis M.I.N.D. Institute||Recruiting|
|Sacramento, California, United States, 95817|
|Principal Investigator: Randi J Hagerman, MD|
|Principal Investigator: Kathleen Angkustsiri, MD|
|Sub-Investigator: David Hessl, PhD|
|Sub-Investigator: Lauren Plumer, MD|
|Sub-Investigator: Flora Tassone, PhD|
|Sub-Investigator: Danh V Nguyen, PhD|
|Sub-Investigator: Andrea Schneider, PhD|
|Sub-Investigator: Louise W Gane, MS|
|Sub-Investigator: Michele Y Ono, MS|
|Sub-Investigator: Susan Harris|
|Sub-Investigator: Susan Bacalman|
|Sub-Investigator: Kylee Cook|
|Sub-Investigator: Antoniya Boyd|
|Sub-Investigator: Norman Brule|
|Sub-Investigator: Emma Hare, CCRP|
|Sub-Investigator: Lindsey Partington|
|Sub-Investigator: Tasleem Chechi|
|Sub-Investigator: Jonathan Polussa|
|Sub-Investigator: Scott Summers, MD, PhD|
|Sub-Investigator: Kerrie Lemons-Chitwood, MA, CCC-SLP|
|Sub-Investigator: Laura Greiss-Hess, MS, OTR/L|
|Sub-Investigator: Kushma Govindappa, MD|
|Sub-Investigator: Gayatri Mahajan, MD|
|Sub-Investigator: Beth Goodlin-Jones, PhD|
|Sub-Investigator: Mary Jacena-Leigh, MD|
|Sub-Investigator: Clara Ramirez|
|Sub-Investigator: Erika Bickel|
|Sub-Investigator: Stephanie Maltas, MS|
|Sub-Investigator: Yingratana McLennan|
|Sub-Investigator: Jessica Burris|
|Sub-Investigator: Lena Rothstein|
|Sub-Investigator: Pam Gallego|
|Sub-Investigator: Emily Owen|
|Sub-Investigator: Laura Berkowitz-Sutherland|
|Principal Investigator:||Randi J Hagerman, MD||UC Davis MIND Institute|
|Principal Investigator:||Kathleen Angkustsiri, MD||UC Davis MIND Institute|