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

NCT03321526

Phase 2 Completed 107 enrolled Janssen Research & Development, LLC
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

EvaluationDrugModalityDoseRoute
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