Non-inferiority, comparative effectiveness study of intravenous ketamine v. intranasal esketamine for treatment-resistant depression: The EQUIVALENCE trial protocol.
Samuel T. Wilkinson, Sandhya Prashad, Rachel Dalthorp, Lisa Harding, Brandon Kitay, Sagar V. Parikh, James Dziura, Ashley Clayton, Geena Fram, Valerie Lepoutre, Julianna Brown, Robert B. Ostroff, Gerard Sanacora
Contemp Clin Trials March 2, 2026 DOI: 10.1016/j.cct.2026.108273 via PubMed
Summary
AI-generated from the abstractThe EQUIVALENCE trial protocol describes a non-inferiority, comparative effectiveness study designed to test whether intranasal esketamine is no less effective than intravenous ketamine for treating treatment-resistant depression. The study will compare the two treatments head-to-head in patients who have not responded to prior antidepressant therapies. The protocol outlines the trial's design, including randomization, dosing regimens, outcome measures, and statistical analysis plan. By directly comparing these two forms of ketamine, the trial aims to provide evidence on whether the more convenient intranasal route can match the efficacy of the intravenous formulation, potentially offering a more accessible treatment option.
Study at a glance
| Characteristics | Non-inferiority, comparative effectiveness study Peer reviewed |
|---|---|
| Population | Patients with treatment-resistant depression |
| Interventions | Intravenous ketamine Intranasal esketamine |
| Citations | 1 |
| Key finding | The protocol describes a planned non-inferiority trial comparing intranasal esketamine to intravenous ketamine for treatment-resistant depression. |
Abstract
Non-inferiority, comparative effectiveness study of intravenous ketamine v. intranasal esketamine for treatment-resistant depression: The EQUIVALENCE trial protocol.