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. 2026 Jan 1:392:120192.
doi: 10.1016/j.jad.2025.120192. Epub 2025 Sep 8.

Real-world clinical data on the long-term effectiveness and safety of generic racemic ketamine treatment

Clara Massaneda-Tuneu  1 , Donel Martin  2 , Nicholas Glozier  3 , Adam Bayes  4 , Thanh Vinh Cao  5 , Nicollette Thornton  3 , Louise Brettell  5 , Stella Antoniou  6 , Ana Rita Barreiros  5 , Michaela Flynn  5 , Vanessa Dong  5 , Elizabeth Lun  6 , Natasha Karunaratne  6 , Dalia Moreno  7 , Justine Ellis  7 , Owen Samuels  7 , Ian Fowler  7 , Michael Bull  7 , Philip B Mitchell  8 , Colleen K Loo  2
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Free article

Real-world clinical data on the long-term effectiveness and safety of generic racemic ketamine treatment

Clara Massaneda-Tuneu et al. J Affect Disord. .
Free article

Abstract

Ketamine is a highly effective treatment for difficult-to-treat or treatment-resistant depression (TRD). The commercially developed intranasal spray containing S-ketamine has demonstrated short and long-term efficacy and safety in phase 3 clinical trials leading to regulatory approval for TRD in many countries. Conversely, generic racemic ketamine is prescribed 'off-label'. There is minimal data on the effectiveness and safety of generic racemic ketamine treatment of >4 weeks duration. The aim of this study was to report the effectiveness and safety of ongoing racemic ketamine treatment for TRD for up to six months in real-world clinical settings. Safety was assessed using a structured monitoring framework (Ketamine Side Effect Tool). Retrospective, deidentified data were collected and analysed from 65 patients with TRD (46.1 ± 14.9 years old; 52.3 % female) who received racemic ketamine treatments over a period of 8 weeks to 6 months. Effectiveness and safety data were summarised using descriptive statistics and frequency distributions. Data suggested effectiveness, with response rates of 35 % at 8 weeks (16/45) and 44.2 % at 6 months (19/43). Suicidality scores improved in 73.3 % of patients at their last available assessment. Similarly, the results indicated that racemic ketamine was well tolerated. Our findings suggest structured safety monitoring facilitated early identification of emerging adverse effects in a few patients, allowing prompt clinical management, with no adverse sequelae. These findings support the effectiveness and safety of long-term racemic ketamine treatment for patients with TRD and highlight the importance of using a structured safety monitoring framework in clinical care.

Keywords: Mood disorders; Racemic ketamine; Treatment resistant depression.

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Conflict of interest statement

Declaration of competing interest The authors declare the following financial interests/personal relationships which may be considered as potential competing interests: Nicollette Thornton reports a relationship with Janssen-Cilag Pty Limited that includes: consulting or advisory. Philip Mitchell reports a relationship with Janssen-Cilag Pty Limited that includes: consulting or advisory and speaking and lecture fees. Colleen Loo reports a relationship with Douglas Pharmaceuticals Ltd. that includes: consulting or advisory. If there are other authors, they declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper.

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