drugset / Trial / NCT00849693
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
- 2011-02
- Completion
- 2011-09
Outcome
Missed primary endpoint
registry analysis (superiority or other test); Duloxetine 60mg vs Placebo; p = 0.193; Mixed Models Analysis NCT00849693 ↗
paper Neither active drug (duloxetine or fluoxetine) separated significantly (p<0.05) from placebo on mean change from baseline to end-point (10 weeks) on the CDRS-R total score. PMID 24815533 ↗
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.
- Emslie GJ, Prakash A, Zhang Q, Pangallo BA, Bangs ME, March JS. A double-blind efficacy and safety study of duloxetine fixed doses in children and adolescents with major depressive disorder. J Child Adolesc Psychopharmacol. 2014 May;24(4):170-9. doi: 10.1089/cap.2013.0096. Epub 2014 May 9.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Duloxetine | Small molecule | 30 mg | Oral |
| Subject | Duloxetine | Small molecule | 60 mg | Oral |
| Comparator | Fluoxetine | Small molecule | 20 mg | Oral |