An Efficacy, Safety and Tolerability Study of JNJ-42165279 in Participants With Major Depressive Disorder With Anxious Distress

Summary

The purpose of this study is to evaluate the efficacy and safety and tolerability of JNJ-42165279 in participants with major depressive disorder (MDD) with anxiety symptoms who have had inadequate response to treatment with a selective serotonin reuptake inhibitor (SSRI) or serotonergic/noradrenergic reuptake inhibitor (SNRI).

Timeline

Start

2015-10-07

Primary completion

2019-02-04

Completion

2019-02-04

Outcome

Missed primary endpoint

registry analysis (superiority test); Placebo vs JNJ-42165279 25 mg; p = 0.416 NCT02498392 ↗

registry analysis (superiority test); Placebo vs JNJ-42165279 25 mg; p = 0.647 NCT02498392 ↗

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	JNJ-42165279	Small molecule	25 mg	Oral

Indications