Fragile X Syndrome | Trial of Sertraline to Treat Children With Fragile X Syndrome
Fragile X Syndrome research study
What is the primary objective of this study?
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.
Who is eligible to participate?
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
Which medical condition, disease, disorder, syndrome, illness, or injury is researched?
Fragile X Syndrome
Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.
Drug:SertralineLiquid sertraline (20 mg/mL) will be dosed in an age-dependent manner. Participants aged 2-3 years of age will be given 2.5 mg (0.125 mL) 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 (0.25 mL) of liquid sertraline once per day for a period of six months.
Drug:PlaceboThe placebo will be dosed in an age-dependent manner. Participants aged 2-3 years of age will be given 2.5 mg (0.125 mL) 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 (0.25 mL) of liquid placebo once per day for a period of six months.
Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.
PlaceboThis arm will undergo identical treatment and assessments as the experimental group, with the exception of the active agent, sertraline. This group will be placed on a placebo.
ActiveThis arm will undergo identical treatment and assessments as the placebo group. This group will receive the active agent, sertraline.
Start Date: January 2012
Completed Date: September 2015
Phase: Phase 2
Primary Outcome: Change in Mullen Scales of Early Learning - Expressive Language Raw Score
Secondary Outcome: Autism Diagnostic Observation Schedule
Study sponsors, principal investigator, and references
Principal Investigator: Randi J Hagerman, MD
Lead Sponsor: Randi J. Hagerman, MD