drugset / Trial / NCT00849901
A Study in the Treatment of Children and Adolescents With Major Depressive Disorder
RandomizedParallel-groupQuadruple-blindTreatment
Summary
The purpose of this study is to assess whether duloxetine is superior to placebo in the treatment of children and adolescents with major depressive disorder (MDD)
Timeline
- Start
- 2009-03
- Primary completion
- 2011-03
- Completion
- 2011-10
Publications
- Emslie GJ, Wells TG, Prakash A, Zhang Q, Pangallo BA, Bangs ME, March JS. Acute and longer-term safety results from a pooled analysis of duloxetine studies for the treatment of children and adolescents with major depressive disorder. J Child Adolesc Psychopharmacol. 2015 May;25(4):293-305. doi: 10.1089/cap.2014.0076.
- Atkinson SD, Prakash A, Zhang Q, Pangallo BA, Bangs ME, Emslie GJ, March JS. A double-blind efficacy and safety study of duloxetine flexible dosing in children and adolescents with major depressive disorder. J Child Adolesc Psychopharmacol. 2014 May;24(4):180-9. doi: 10.1089/cap.2013.0146. Epub 2014 May 9.
- Bliznak L, Berg R, Hage A, Dittmann RW. High rate of non-eligibility: methodological factors impacting on recruitment for a multicentre, double-blind study of paediatric patients with major depressive disorder. Pharmacopsychiatry. 2013 Jan;46(1):23-8. doi: 10.1055/s-0032-1314806. Epub 2012 Jun 14.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Duloxetine | Small molecule | 30 mg | Oral |
| Subject | Duloxetine | Small molecule | 120 mg | Oral |
| Comparator | Fluoxetine | Small molecule | 10 mg | Oral |
| Comparator | Fluoxetine | Small molecule | 40 mg | Oral |