A Study of JNJ-61393215 in the Treatment of Depression

Phase 2 Completed 222 enrolled Janssen Research & Development, LLC

RandomizedParallel-groupDouble-blindTreatment

Summary

The purpose of this study is to evaluate the efficacy of JNJ-61393215 as adjunctive treatment compared to adjunctive placebo, as assessed by the change from baseline to week 6 on a 17-item Hamilton Depression Rating Scale (HDRS-17) in participants with major depressive disorder (MDD) with anxious distress with a score greater than or equal to (\>=) 2 on item 26 or 27 of the Inventory of Depressive Symptomatology, Clinician Rating -30 (IDS-C30), who have a suboptimal response to current treatment with a standard antidepressant.

Timeline

Start: 2019-09-17
Primary completion: 2021-09-02
Completion: 2021-09-02

Outcome

Missed primary endpoint

registry p = 0.2494; Least Square (LS) Mean Difference -0.61 (80% CI -1.76 to 0.55) NCT04080752 ↗

paper The study results for the full intent-to-treat analysis dataset did not show significant treatment effects of adjunctive treatment with JNJ-61393215 on either the primary endpoint PMID 40215570 ↗

Publications

Schmidt ME, Moyer JA, Kezic I, Zhou X, Samtani MN, Bleys C, Dallas S, Salvadore G, Drevets WC. Efficacy, safety, and tolerability of JNJ-61393215 (tebideutorexant), a selective orexin-1 receptor antagonist, as adjunctive treatment for major depressive disorder with anxious distress: A double-blind, placebo-controlled, randomized phase 2a study. Eur Neuropsychopharmacol. 2025 Jun;95:14-23. doi: 10.1016/j.euroneuro.2025.03.007. Epub 2025 Apr 13.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	TEBITOREXANT	Small molecule	135 mg	Oral