drugset / Trial / NCT01396486

Inositol and Omega-3 Fatty Acids in Pediatric Mania

NCT01396486

Phase 4 Completed 69 enrolled Massachusetts General Hospital
RandomizedSingle-groupQuadruple-blindTreatment

Summary

The purpose of this study is to a) evaluate the efficacy of omega-3 fatty acids versus inositol in the treatment of pediatric bipolar disorder, b) evaluate the efficacy of omega-3 fatty acid plus inositol in the treatment of pediatric bipolar disorder, and c) assess the side effect profile of omega-3 fatty acids plus inositol. This study will be a 12-week trial with children ages 5-12 years old with bipolar spectrum disorders.

Timeline

Start
2012-02-03
Primary completion
2019-04-11
Completion
2019-04-11

Drugs

EvaluationDrugModalityDoseRoute
Comparator Inositol Small molecule 80 mg/kg
Comparator Inositol Small molecule 2000 mg
Comparator Omega-3 fatty acids Unknown 3000 mg

Indications