Inositol and Omega-3 Fatty Acids in Pediatric Mania

PHASE4CompletedINTERVENTIONAL
Enrollment

69

Participants

Timeline

Start Date

February 3, 2012

Primary Completion Date

April 11, 2019

Study Completion Date

April 11, 2019

Conditions
Pediatric Bipolar Spectrum Disorders
Interventions
DRUG

Omega-3

Children with bipolar spectrum disorders ages 6-12 will receive treatment with omega-3 fatty acids. Study subjects may be randomized to receive 3000mg (6 500mg capsules) of omega-3 fatty acids for the duration of the study. Omega-3 fatty acid capsules are in the form of Nordic Naturals brand, ProOmega Junior, which contains 325mg EPA and 225mg DHA per two capsules.

DRUG

Inositol

Children with bipolar spectrum disorders ages 6-12 will receive treatment with inositol, omega-3 fatty acids, or both weekly for 12 weeks. Subjects weighing 25kg or more may be randomized to receive 2000mg (4 500mg capsules) of inositol (80mg/kg for a 25kg child). Children weighing less than 25kg will be dosed at 80mg/kg rounded down to the nearest thousand mg dose. Dosage will remain constant throughout the study.

Trial Locations (1)

02114

Massachusetts General Hospital, Boston

All Listed Sponsors
lead

Massachusetts General Hospital

OTHER

NCT01396486 - Inositol and Omega-3 Fatty Acids in Pediatric Mania | Biotech Hunter | Biotech Hunter