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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

Study Interventions

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.

Study Arms

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.

Study Status

Completed

Start Date: January 2012

Completed Date: September 2015

Phase: Phase 2

Type: Interventional

Design:

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

Collaborator:

More information:https://clinicaltrials.gov/show/NCT01474746

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