drugset / Trial / NCT00844857
A Study for Assessing Treatment of Patients Ages 10-17 With Bipolar Depression
RandomizedParallel-groupQuadruple-blindTreatment
Summary
The main goal of this study is to help answer the following research question(s) and not to treat the child's illness. * Can this study drug make children with bipolar depression feel better? * Does this study drug work better than a placebo (sugar pill)? * Does this study drug cause side effects in children who take it? * Is this drug safe to use in children? (The study drug is a mixture of olanzapine and fluoxetine)
Timeline
- Start
- 2009-04
- Primary completion
- 2012-02
- Completion
- 2012-02
Publications
- Walker DJ, DelBello MP, Landry J, D'Souza DN, Detke HC. Quality of life in children and adolescents with bipolar I depression treated with olanzapine/fluoxetine combination. Child Adolesc Psychiatry Ment Health. 2017 Jul 12;11:34. doi: 10.1186/s13034-017-0170-7. eCollection 2017.
- Detke HC, DelBello MP, Landry J, Usher RW. Olanzapine/Fluoxetine combination in children and adolescents with bipolar I depression: a randomized, double-blind, placebo-controlled trial. J Am Acad Child Adolesc Psychiatry. 2015 Mar;54(3):217-24. doi: 10.1016/j.jaac.2014.12.012. Epub 2014 Dec 29.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Fluoxetine | Small molecule | 25 mg | Oral |
| Subject | Fluoxetine | Small molecule | 50 mg | Oral |
| Subject | Olanzapine | Small molecule | 3 mg | Oral |
| Subject | Olanzapine | Small molecule | 6 mg | Oral |
| Subject | Olanzapine | Small molecule | 12 mg | Oral |