1. Arketamine for bipolar depression: Open-label, dose-escalation, pilot study.
- Author
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Bandeira ID, Leal GC, Correia-Melo FS, Souza-Marques B, Silva SS, Lins-Silva DH, Mello RP, Vieira F, Dorea-Bandeira I, Faria-Guimarães D, Carneiro B, Caliman-Fontes AT, Kapczinski F, Miranda-Scippa Â, Lacerda ALT, and Quarantini LC
- Subjects
- Female, Humans, Male, Antidepressive Agents therapeutic use, Depression, Double-Blind Method, Pilot Projects, Treatment Outcome, Bipolar Disorder drug therapy, Bipolar Disorder diagnosis, Depressive Disorder, Major drug therapy, Ketamine
- Abstract
There are significantly fewer options for the treatment of bipolar depression than major depressive disorder, with an urgent need for alternative therapies. In this pilot study, we treated six subjects with bipolar disorder types I and II (according to the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) criteria) who had been in a current depressive episode for at least four weeks. Four subjects were female (66.66%), and the mean age was 45.33 (±12.32). Subjects received adjunct treatment with two arketamine intravenous infusions one week apart-0.5 mg/kg first and then 1 mg/kg. The mean baseline Montgomery-Åsberg Depression Rating Scale (MADRS) total score was 36.66, which decreased to 27.83 24h after the first infusion of 0.5 mg/kg of arketamine (p = 0.036). In respect of the 1 mg/kg dose, the mean MADRS total score before the second infusion was 32.0, which dropped to 17.66 after 24h (p < 0.001). Arketamine appears to have rapid-acting antidepressant properties, consistent with previous animal studies on major depression. All individuals tolerated both doses, exhibiting nearly absent dissociation, and no manic symptoms. To the best of our knowledge, this pilot trial is the first to test the feasibility and safety of the (R)-enantiomer of ketamine (arketamine) for bipolar depression., Competing Interests: Declaration of competing interest Dr. Quarantini reports consulting fees from Allergan, Abbott, Janssen Pharmaceuticals and Lundbeck and research fees from Janssen Pharmaceuticals. Dr. Lacerda reports grants and personal fees from Janssen Pharmaceuticals, personal fees from Daiichi Sankyo, Cristalia Produtos Químicos e Farmacêuticos, Libbs, Pfizer, Myralis Farma, Aché Laboratórios, Hypera Pharmaand Sanofi-Aventis, grants from Eli Lilly, H. Lundbeck A/S, Servier Laboratories, Hoffman-La Roche, Forum Pharmaceuticals and from public programs: CNPq and FAPESP., (Copyright © 2023 Elsevier Ltd. All rights reserved.)
- Published
- 2023
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