NCT04080752

A Study of JNJ-61393215 in the Treatment of Depression

Double-Blind, Placebo-Controlled, Multi-Center Study Investigating the Efficacy, Safety, and Tolerability of JNJ-61393215 as Adjunctive Treatment in Adults With Major Depressive Disorder With Anxious Distress With Suboptimal Response to Standard Antidepressants

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 222 (actual)
• Sponsor: Janssen Research & Development, LLC · Industry
• Sex: All
• Age: 18 Years – 64 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Major Depressive Disorder With Anxious Distress

Interventions

Type	Name	Description
DRUG	JNJ-61393215	JNJ-61393215 will be administrated orally.
DRUG	Placebo	Matching placebo will be administered orally.

Timeline

• Start date: 2019-09-17
• Primary completion: 2021-09-02
• Completion: 2021-09-02
• First posted: 2019-09-06
• Last updated: 2025-04-29
• Results posted: 2022-09-29

Locations

35 sites across 5 countries: United States, Moldova, Russia, Ukraine, United Kingdom

Regulatory

• FDA-regulated drug study