drugset / Trial / NCT00592683
Omega-3 Fatty Acid Adjunctive to Open-Label Aripiprazole for the Treatment of Bipolar Disorder in Children and Adolescents
RandomizedSingle-groupTriple-blindTreatment
Summary
This will be a 12 week, double blind study of omega-3 fatty acids vs. placebo adjunctive to open-label aripiprazole treatment in children and adolescents (ages 6-17) who meet DSM-IV criteria for bipolar disorder (BPD) (currently manic or mixed). Specific hypotheses are as follows: Hypothesis 1: Omega-3 fatty acids will be well-tolerated and efficacious in the treatment of children and adolescents with BPD Hypothesis 2: The total dose of aripiprazole will be lower in those subjects receiving active omega-3 treatment
Timeline
- Start
- 2007-12
- Primary completion
- 2010-04
- Completion
- 2010-04
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Aripiprazole | Other / unclassified | 2 mg | — |