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Repeated subcutaneous esketamine on treatment-resistant depression: An open-label dose titration study.

Fernanda Palhano-Fontes, Patrícia Cavalcanti-Ribeiro, Kaike Thiê da Costa Gonçalves, Victor Rocha Nobrega de Almeida, David C Barbosa, Marcos André de Araújo Ferreira, Raynara Bolcont, Lara Carvalho Araújo Melo De Souza, Nestor Caetano Santos, Eduardo Igor Torquato Cardoso Lopes, Nicole Bezerra de Medeiros Lima, Aldielyson Jorge Cavalcanti de Brito, Marcelo Falchi-Carvalho, Emerson Arcoverde, Draulio B Araujo, Nicole Leite Galvão‐coelho

Journal of Affective Disorders January 15, 2025 DOI: 10.1016/j.jad.2024.09.141 (opens in new tab)

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Study at a glance

AI-extracted from the abstract
Characteristics Open-label clinical trial Peer reviewed
Sample size 30
Population Patients with unipolar treatment-resistant depression
Intervention Subcutaneous esketamine
Duration 8-week intervention, 6-month follow-up
Topics Depression Ketamine Esketamine
Keywords Subcutaneous Unipolar depression Depression treatment Ketamine therapy Mental health research Psychiatric medicine
Citations 7
Key findings Eight weekly subcutaneous esketamine sessions yielded a 52.17% response rate and 34.78% remission rate, with sustained antidepressant effects up to six months.

Abstract

Ketamine has gained prominence as one of the most effective therapeutic options in unipolar treatment-resistant depression (TRD). However, most studies related to the antidepressant action of ketamine used intravenous (IV) or intranasal (IN) administration. The subcutaneous (SC) route of administration is a promising alternative, as it results in plasma levels comparable to IV, causes fewer side effects, and is easier and cheaper to administer than both IV and/or IN routes. In this context, we conducted an open-label clinical trial for investigating the efficacy and safety of 8 weekly sessions of SC esketamine in TRD patients (n = 30). At the end of the treatment, a partial response rate of 26.09 %, a response rate of 52.17 % and remission rate of 34.78 % were observed, assessed by Montgomery-Åsberg Depression Rating Scale. Moreover, the self-reported depressive symptoms, as measured by the Beck Depression Inventory II (BDI-II), significantly decreased from the baseline to the final session, and the improvements were sustained throughout the week. Follow-up evaluations (BDI-II) up to the sixth month consistently showed scores lower than the baseline. The small sample size and the drop-out during the follow-up phase may limit the generalizability of the findings. Additionally, the absence of a control group necessitates cautious interpretation of causality. This groundbreaking study, which addresses SC esketamine treatment for TRD, reported promising response and remission rates, as well as sustained antidepressant effects. It highlights the need for further research to improve and expand our knowledge of this innovative, more accessible, and cost-effective therapeutic approach.

Comparable studies

Other non-randomized and open-label trials on esketamine for depression, most cited first.

Study Year Design Participants
Esketamine Nasal Spray Plus Oral Antidepressant in Patients With Treatment-Resistant Depression Adults (≥ 18 years) with treatment-resistant depression 2020 Phase 3, open-label, multicenter, long-term study n = 802
Long-Term Safety and Maintenance of Response With Esketamine Nasal Spray in Participants With Treatment-Resistant Depression: Interim Results of the SUSTAIN-3 Study Adults with treatment-resistant depression 2023 Open-label, long-term extension study n = 1,148
Safety and efficacy with esketamine in treatment-resistant depression: long-term extension study. Adults with treatment-resistant depression who participated in ≥1 of 6 phase 3 parent... 2025 Open-label, single-arm long-term extension study n = 1,148
Efficacy and Safety of Intranasal Esketamine in Patients With Treatment-Resistant Depression and Comorbid Chronic Post-traumatic Stress Disorder: Open-Label Single-Arm Pilot Study Patients with treatment-resistant major depressive disorder and comorbid post-traumatic... 2022 Open-label, single-arm, retrospective pilot study n = 11
Rapid and long-lasting effects of subcutaneous esketamine on suicidality: An open-label study in patients with treatment-resistant depression. Treatment-resistant depressive patients 2024 Open-label clinical trial n = 18

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