NCT01474746View on ClinicalTrials.gov

Trial of Sertraline to Treat Children With Fragile X Syndrome

PHASE2CompletedINTERVENTIONAL
Enrollment

57

Participants

Timeline

Start Date

January 31, 2012

Primary Completion Date

August 31, 2015

Study Completion Date

September 30, 2015

Conditions
Fragile X Syndrome
Interventions
DRUG

Sertraline

Liquid 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

Placebo

The 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.

Trial Locations (1)

95817

UC Davis M.I.N.D. Institute, Sacramento

All Listed Sponsors
lead

Randi J. Hagerman, MD

OTHER

NCT01474746 - Trial of Sertraline to Treat Children With Fragile X Syndrome | Biotech Hunter | Biotech Hunter