Omega-3 Fatty Acids in Children and Adolescents With Bipolar Disorder

NACompletedINTERVENTIONAL
Enrollment

65

Participants

Timeline

Start Date

November 30, 2001

Primary Completion Date

June 30, 2005

Study Completion Date

June 30, 2005

Conditions
Bipolar Disorder
Interventions
DRUG

Flax oil

Flax oil and olive oil placebo were analyzed for quality and purity; sufficient bioactivity was confirmed for the flax oil independently at the University of Massachusetts mid-way through the study. Each capsule of omega -3 fatty acid concentrate contained 550 mg of α-linolenic acid (α-LNA) from flax seed oil.A stepped but flexible dose-titration schedule was carried out with doses increased by 1-2 grams at each visit as tolerated, to an attempted total dose of 6 capsules twice per day, as requested by the FDA (up to 6.6 grams of daily α-linolenic acid).

Trial Locations (1)

14642

University of Rochester, Rochester

All Listed Sponsors
collaborator

Stanley Medical Research Institute

OTHER

lead

University of Rochester

OTHER

NCT00252486 - Omega-3 Fatty Acids in Children and Adolescents With Bipolar Disorder | Biotech Hunter | Biotech Hunter