drugset / Trial / NCT03321526
A Study to Compare the Efficacy, Safety, and Tolerability of JNJ-42847922 Versus Quetiapine Extended-Release as Adjunctive Therapy to Antidepressants in Adult Participants With Major Depressive Disorder Who Have Responded Inadequately to Antidepressant Therapy
RandomizedParallel-groupDouble-blindTreatment
Summary
The purpose of this study is to assess the efficacy of flexibly dosed JNJ-42847922 (20 milligram \[mg\] or 40 mg) compared to flexibly dosed quetiapine extended-release (XR) (150 mg or 300 mg) as adjunctive therapy to an antidepressant drug in delaying time to all-cause discontinuation of study drug over a 6-months (24 weeks) treatment period, in participants with major depressive disorder (MDD) who have had an inadequate response to current antidepressant therapy with a selective serotonin reuptake inhibitor (SSRI) or serotonin-norepinephrine reuptake inhibitor (SNRI).
Timeline
- Start
- 2017-12-12
- Primary completion
- 2019-06-13
- Completion
- 2019-06-27
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Quetiapine | Small molecule | 150 mg | Oral |
| Comparator | Quetiapine | Small molecule | 300 mg | Oral |
| Subject | Seltorexant | Small molecule | 20 mg | Oral |
| Subject | Seltorexant | Small molecule | 40 mg | Oral |
| Background | Citalopram | Small molecule | — | — |
| Background | Desvenlafaxine | Other / unclassified | — | — |
| Background | Duloxetine | Small molecule | — | — |
| Background | Escitalopram | Small molecule | — | — |
| Background | Fluoxetine | Small molecule | — | — |
| Background | Fluvoxamine | Unknown | — | — |
| Background | Levomilnacipran | Small molecule | — | — |
| Background | Milnacipran | Other / unclassified | — | — |
| Background | Paroxetine | Small molecule | — | — |
| Background | Sertraline | Small molecule | — | — |
| Background | Venlafaxine | Small molecule | — | — |
| Background | Vilazodone | Small molecule | — | — |
| Background | Vortioxetine | Unknown | — | — |