drugset / Trial / NCT01396486
Inositol and Omega-3 Fatty Acids in Pediatric Mania
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
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Inositol | Small molecule | 80 mg/kg | — |
| Comparator | Inositol | Small molecule | 2000 mg | — |
| Comparator | Omega-3 fatty acids | Unknown | 3000 mg | — |