Phase 2 N=57 Randomized Triple-blind Treatment

Trial of Sertraline to Treat Children With Fragile X Syndrome

Fragile X Syndrome

Bottom Line

View on ClinicalTrials.gov: NCT01474746 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Sep 2017

Primary outcome: Primary: Change in Mullen Scales of Early Learning - Expressive Language Raw Score — 19.3; 21.3; 21.3; 25.04 units on a scale

Study Design & Population

Study type: Interventional
Phase: Phase 2
Interventions: Sertraline (Drug); Placebo (Drug)
Age: Pediatric · 0+ yrs
Sex: All
Sponsor: Randi J. Hagerman, MD
Primary completion: Aug 2015

Outcome Measures

Outcome	Result	p-value
PRIMARY Change in Mullen Scales of Early Learning - Expressive Language Raw Score	19.3; 21.3; 21.3; 25.04	—
PRIMARY Clinical Global Impression - Improvement	2.59; 2.28	—
PRIMARY Change in Mullen Scales of Early Learning - Expressive Language Standard T Score	23.3; 25.8; 22.6; 25.8	—
SECONDARY Autism Diagnostic Observation Schedule	10.73; 11.00	—
SECONDARY Visual Analog Scale	2.95; 2.62	—
SECONDARY Eye Tracking	0.505969231; 0.538312222	—
SECONDARY Preschool Language Scale-fifth Edition (PLS-5): AC+EC Total Raw Score	59.89; 62.80	—
SECONDARY Sensory Processing Measure - Preschool (SPM-P) Social Participation: Raw Score	20.6; 20.5	—
SECONDARY Sensory Profile - Sensation Seeking Subscale Raw Score	—	—
SECONDARY Vineland Adaptive Behavior Scales, Second Edition (Vineland-II) - Adaptive Behavior Composite Standard Score	73.3; 66.5	—
SECONDARY Mullen Scales of Early Learning - Visual Reception Raw Score	30.9; 32.4	—
SECONDARY Mullen Scales of Early Learning - Fine Motor Raw Score	25.2; 27.3	—
SECONDARY The Autism Diagnostic Observation Schedule (ADOS-2)	11.00; 11.67	—
SECONDARY The Visual Analog Scale	5.16; 5.58	—
SECONDARY Eye Tracking	0.505969231; 0.538312222	—
SECONDARY Preschool Language Scale-fifth Edition (PLS-5): AC+EC Total Raw Score	59.89; 62.80	—
SECONDARY Sensory Processing Measure-Preschool (SPM-P) Social Participation: Raw Score	19.7; 18.0	—
SECONDARY Sensory Profile - Sensation Seeking Subscale Raw Score	—	—
SECONDARY Vineland Adaptive Behavior Scales, Second Edition (Vineland-II) Adaptive Behavior Composite Standard Score	74.5; 66.4	—
SECONDARY Mullen Scales of Early Learning - Visual Reception Raw Score	30.9; 32.4	—
SECONDARY Mullen Scales of Early Learning - Visual Reception Age-equivalent Score	30.6; 33.7	—
SECONDARY Mullen Scales of Early Learning - Visual Reception Age-equivalent Score	30.6; 33.7	—
SECONDARY Mullen Scales of Early Learning - Fine Motor Raw Score	25.2; 27.3	—
SECONDARY Mullen Scales of Early Learning - Fine Motor Age-equivalent Score	25.0; 28.4	—
SECONDARY Mullen Scales of Early Learning - Fine Motor Age-equivalent Score	25.0; 28.4	—
SECONDARY Mullen Scales of Early Learning - Cognitive T Score Sum	93.0; 105.4	—
SECONDARY Mullen Scales of Early Learning - Cognitive T Score Sum	93.0; 105.4	—
SECONDARY Mullen Scales of Early Learning - Summary Age-equivalent Score	23.6; 30.1	—
SECONDARY Mullen Scales of Early Learning - Summary Age-equivalent Score	23.6; 30.1	—

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.

Eligibility 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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01474746). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.