A Study to Evaluate the Efficacy and Safety of JNJ-42847922 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 dose-response relationship of 2 doses of JNJ-42847922 before interim analysis, and potentially 3 doses based on interim analysis results, compared to placebo as adjunctive therapy to an antidepressant drug in improving depressive symptoms 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); and to assess the safety and tolerability of JNJ-42847922 compared to placebo as adjunctive therapy to an antidepressant in participants with MDD.

Timeline

Start

2017-08-16

Primary completion

2019-01-12

Completion

2019-01-19

Outcome

Sources disagree · no verdict is set; each source's reading is shown below

registry Placebo vs Seltorexant 20 mg; p = 0.083; Difference of Least Square Means -3.1 (90% CI -6.13 to -0.16) reads as missed primary endpoint NCT03227224 ↗

registry Placebo vs Seltorexant 10 mg; p = 0.724; Difference of Least Square Means 0.9 (90% CI -3.12 to 4.82) reads as missed primary endpoint NCT03227224 ↗

registry Placebo vs Seltorexant 40 mg; p = 0.424; Difference of Least Square Means -1.5 (90% CI -4.70 to 1.63) reads as missed primary endpoint NCT03227224 ↗

release “positive top line results from a Phase 2b clinical trial of seltorexant as adjunctive therapy to antidepressants in adult patients with MDD” reads as met primary endpoint minervaneurosciences.com ↗

Publications

• Savitz A, Wajs E, Zhang Y, Xu H, Etropolski M, Thase ME, Drevets WC. Efficacy and Safety of Seltorexant as Adjunctive Therapy in Major Depressive Disorder: A Phase 2b, Randomized, Placebo-Controlled, Adaptive Dose-Finding Study. Int J Neuropsychopharmacol. 2021 Dec 8;24(12):965-976. doi: 10.1093/ijnp/pyab050.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Seltorexant	Small molecule	10 mg	Oral
Subject	Seltorexant	Small molecule	20 mg	Oral
Subject	Seltorexant	Small molecule	40 mg	Oral

Indications