Trial of Sertraline to Treat Children With Fragile X Syndrome
| Status: | Completed |
|---|---|
| Conditions: | Other Indications |
| Therapuetic Areas: | Other |
| Healthy: | No |
| Age Range: | Any |
| Updated: | 4/21/2016 |
| Start Date: | January 2012 |
| End Date: | September 2015 |
A Controlled Trial of Sertraline in Young 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.
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.
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.
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.
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
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