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

A 6-Month, Multicenter, Double-Blind, Randomized, Flexible-Dose, Parallel-Group Study to Compare the Efficacy, Safety, and Tolerability of JNJ-42847922 Versus Quetiapine Extended-Release as Adjunctive Therapy to Antidepressants in Adult Subjects With Major Depressive Disorder Who Have Responded Inadequately to Antidepressant Therapy

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 107 (actual)
• Sponsor: Janssen Research & Development, LLC · Industry
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

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).

Conditions

• Depressive Disorder, Major

Interventions

Type	Name	Description
DRUG	JNJ-42847922	Participants will receive JNJ-42847922 capsule orally.
DRUG	Placebo Matching to JNJ-42847922	Participants will receive placebo capsule matching to JNJ-42847922 orally.
DRUG	Quetiapine XR	Participants will receive quetiapine XR capsule orally.
DRUG	Placebo Matching to Quetiapine XR	Participants will receive placebo capsule matching to quetiapine XR orally.
DRUG	Selective Serotonin Reuptake Inhibitor (SSRI)	Participants will receive SSRI antidepressant (such as, citalopram, escitalopram, fluvoxamine, fluoxetine, paroxetine, sertraline, vilazodone or vortioxetine) as a part of background therapy (at the same dose, without change, every day and at approximately the same time as prior to entering the study) throughout the screening, double-blind, and follow-up phases (approximately up to Week 26).
DRUG	Serotonin-Norepinephrine Reuptake Inhibitor (SNRI)	Participants will receive SNRI antidepressant (such as duloxetine, milnacipran, levomilnacipran, venlafaxine, desvenlafaxine) as a part of background therapy (at the same dose, without change, every day and at approximately the same time as prior to entering the study) throughout the screening, double-blind, and follow-up phases (approximately up to Week 26).

Timeline

• Start date: 2017-12-12
• Primary completion: 2019-06-13
• Completion: 2019-06-27
• First posted: 2017-10-25
• Last updated: 2025-04-29
• Results posted: 2022-08-16

Locations

50 sites across 1 country: United States

Regulatory

• FDA-regulated drug study