Safety and efficacy with esketamine in treatment-resistant depression: long-term extension study.

ABSTRACT:

Importance

The rates of relapse and suicide risk are higher in treatment-resistant depression (TRD) vs non-treatment-resistant major depressive disorder. Even among patients with TRD who initially respond, the majority (70%) relapse within 6 months.

Objective

To evaluate the long-term safety and efficacy of esketamine nasal spray, combined with an oral antidepressant, in patients with TRD.

Design

Phase 3, open-label, single-arm long-term extension study (SUSTAIN-3) conducted from June 2016 to December 2022.

Setting

Outpatient.

Participants

Adults with TRD who participated in ≥1 of 6 phase 3 "parent" studies continued esketamine by either entering a 4-week induction phase followed by an optimization/maintenance phase of variable duration (n = 458) or dire

SUBMITTER: Zaki N 

PROVIDER: S-EPMC12143125 | biostudies-literature | 2025 Jun

REPOSITORIES: biostudies-literature