Completed PHASE3 INTERVENTIONAL 2-arm NCT03434041

A Study to Evaluate the Efficacy, Pharmacokinetics, Safety and Tolerability of Flexible Doses of Intranasal Esketamine Plus an Oral Antidepressant in Adult Participants With Treatment-resistant Depression

A Randomized, Double-blind, Multicenter Active-controlled Study to Evaluate the Efficacy, Pharmacokinetics, Safety and Tolerability of Flexible Doses of Intranasal Esketamine Plus an Oral Antidepressant in Adult Subjects With Treatment-resistant Depression

Sponsor: Janssen Research & Development, LLC

Conditions Depressive Disorder, Treatment-Resistant

Interventions Duloxetine (Oral Antidepressant) Escitalopram (Oral Antidepressant) Esketamine 56 mg Esketamine 84 mg Placebo Sertraline (Oral Antidepressant) Venlafaxine Extended Release (XR) (Oral Antidepressant)

Updated 28 times since 2018 Last updated: Apr 25, 2025 Started: May 25, 2018 Primary completion: Apr 13, 2021 Completion: Apr 13, 2021

This information is for research purposes only and is not medical advice. Consult a healthcare provider before making any medical decision.

A PHASE3 clinical study on Depressive Disorder, Treatment-Resistant, this trial is completed. The trial is conducted by Janssen Research & Development, LLC and has accumulated 28 data snapshots since 2018. Longitudinal tracking of this trial contributes to a broader understanding of treatment development timelines.

Status Flow

Change History

28 versions recorded

Sep 2025 — Present [monthly]

Completed PHASE3
May 2025 — Sep 2025 [monthly]

Completed PHASE3
Mar 2025 — May 2025 [monthly]

Completed PHASE3
Sep 2024 — Mar 2025 [monthly]

Completed PHASE3
Jul 2024 — Sep 2024 [monthly]

Completed PHASE3

▶ Show 23 earlier versions

May 2024 — Jul 2024 [monthly]

Completed PHASE3
Jun 2022 — May 2024 [monthly]

Completed PHASE3
Jun 2021 — Jun 2022 [monthly]

Completed PHASE3

Status: Active Not Recruiting → Completed
May 2021 — Jun 2021 [monthly]

Active Not Recruiting PHASE3
Apr 2021 — May 2021 [monthly]

Active Not Recruiting PHASE3
Mar 2021 — Apr 2021 [monthly]

Active Not Recruiting PHASE3

Status: Recruiting → Active Not Recruiting
Jan 2021 — Mar 2021 [monthly]

Recruiting PHASE3
Aug 2020 — Jan 2021 [monthly]

Recruiting PHASE3
Dec 2019 — Aug 2020 [monthly]

Recruiting PHASE3
Oct 2019 — Dec 2019 [monthly]

Recruiting PHASE3
Aug 2019 — Oct 2019 [monthly]

Recruiting PHASE3
May 2019 — Aug 2019 [monthly]

Recruiting PHASE3
Apr 2019 — May 2019 [monthly]

Recruiting PHASE3
Mar 2019 — Apr 2019 [monthly]

Recruiting PHASE3
Dec 2018 — Mar 2019 [monthly]

Recruiting PHASE3
Nov 2018 — Dec 2018 [monthly]

Recruiting PHASE3
Oct 2018 — Nov 2018 [monthly]

Recruiting PHASE3
Sep 2018 — Oct 2018 [monthly]

Recruiting PHASE3
Aug 2018 — Sep 2018 [monthly]

Recruiting PHASE3
Jul 2018 — Aug 2018 [monthly]

Recruiting PHASE3

Status: Not Yet Recruiting → Recruiting
Jun 2018 — Jul 2018 [monthly]

Not Yet Recruiting PHASE3
May 2018 — Jun 2018 [monthly]

Not Yet Recruiting PHASE3
Mar 2018 — May 2018 [monthly]

Not Yet Recruiting PHASE3

First recorded

Eligibility Summary

No eligibility information available.

Contact Information

Sponsor contact:

Janssen Research & Development, LLC

Data source: Janssen Research & Development, LLC

For direct contact, visit the study record on ClinicalTrials.gov .

Study Locations

Atlanta, United States , Beijing, China , Changsha, China , Chengdu, China , Chongqing, China , Gaithersburg, United States , Guangzhou, China , Hangzhou, China , Huzhou, China , Kunming, China and 12 more locations