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

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

Outcome

Missed primary endpoint

registry analysis (superiority test); Seltorexant vs Quetiapine XR; p = 0.5355; Log Rank NCT03321526 ↗

paper did not differ significantly between treatment groups. PMID 41795948 ↗

Publications

• Pinter C, Thase ME, McIntyre RS, Cooper K, Xu H, Pandina G, Savitz A, Drevets WC. Safety, tolerability, and preliminary efficacy of seltorexant versus quetiapine extended release as adjunctive therapy in major depressive disorder: a randomized, flexible-dose, 6-month, parallel-group, exploratory study. Int J Neuropsychopharmacol. 2026 Apr 6;29(4):pyag009. doi: 10.1093/ijnp/pyag009.

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	—	—

Indications