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Clinical trial

A Randomized, Open-label, Rater-Blinded, Active-Controlled, International, Multicenter Study to Evaluate the Efficacy, Safety, and Tolerability of Flexibly Dosed Esketamine Nasal Spray Compared With Quetiapine Extended-Release in Adult and Elderly Participants With Treatment-Resistant Major Depressive Disorder Who Are Continuing a Selective Serotonin Reuptake Inhibitor/Serotonin-Norepinephrine Reuptake Inhibitor

NCT04338321 is registered in ClinicalTrials.gov with Janssen-Cilag International NV as lead sponsor.

NCT NCT04338321
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Registry record

As filed in ClinicalTrials.gov.

Title
A Randomized, Open-label, Rater-Blinded, Active-Controlled, International, Multicenter Study to Evaluate the Efficacy, Safety, and Tolerability of Flexibly Dosed Esketamine Nasal Spray Compared With Quetiapine Extended-Release in Adult and Elderly Participants With Treatment-Resistant Major Depressive Disorder Who Are Continuing a Selective Serotonin Reuptake Inhibitor/Serotonin-Norepinephrine Reuptake Inhibitor
Lead sponsor
Janssen-Cilag International NV
Phase
Phase 3
Overall status
Completed
Start date
August 21, 2020
Completion date
July 15, 2022
Enrollment
676 (actual)
Sites
171

Conditions

As the registry lists them; a condition with its own page is linked.

depressive disorder, major