A Study to Investigate the Antidepressant Mechanism-of-action of JNJ-42847922 in Participants With Major Depressive Disorder

Phase 1 Completed 140 enrolled Janssen Research & Development, LLC

RandomizedParallel-groupDouble-blindTreatment

Summary

The purpose of this study is to explore if the magnitude of treatment effect (JNJ-42847922; placebo) on symptoms of depression (as measured by Hamilton rating scale for depression-17 \[HDRS17\], Sleep item-adjusted HDRS17, Anxiety/somatization factor score and the 6-item subscale from HDRS17 \[HAM-D6\]) differs across different levels of hyper-arousal status (characterized by Sleep parameters, ruminative response scale \[RRS\], Sleep and Worry visual analogue scale \[VAS\], quantitative electro-encephalography \[qEEG\], heart rate variability \[HRV\] and others).

Timeline

Start: 2018-01-05
Primary completion: 2019-04-29
Completion: 2019-04-29

Outcome

Met primary endpoint

paper -7.0 (5.04) for seltorexant 20 mg, -5.5 (4.34) for seltorexant 40 mg, and -4.4 (3.67) for placebo (p = 0.0456) PMID 39663378 ↗

paper which was attributable to the difference between the 20 mg and placebo arms (p = 0.0049). PMID 39663378 ↗

Publications

Mesens S, Kezic I, Van Der Ark P, Etropolski M, Pandina G, Benes H, Savitz A, Drevets WC. Treatment effect and safety of seltorexant as monotherapy for patients with major depressive disorder: a randomized, placebo-controlled clinical trial. Mol Psychiatry. 2025 Jun;30(6):2427-2435. doi: 10.1038/s41380-024-02846-5. Epub 2024 Dec 11.

Drugs

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