2023-07-14 ニューサウスウェールズ大学(UNSW)
◆この研究は、オーストラリアとニュージーランドの7つの臨床気分障害ユニットによる共同研究で、オーストラリア国立保健医療研究評議会(NHMRC)の資金援助を受けて行われた。この治療法は一般的なケタミンよりも安価であり、効果が早く現れることから、うつ病治療の新たな選択肢となる可能性がある。
<関連情報>
- https://newsroom.unsw.edu.au/news/health/ketamine-effective-treatment-resistant-depression-clinical-trial
- https://www.cambridge.org/core/journals/the-british-journal-of-psychiatry/article/efficacy-and-safety-of-a-4week-course-of-repeated-subcutaneous-ketamine-injections-for-treatmentresistant-depression-kads-study-randomised-doubleblind-activecontrolled-trial/FDBAEC51F0891B57F5B04C572D13DA17
治療抵抗性うつ病に対するケタミン皮下注射の反復4週間コースの有効性と安全性(KADS試験):無作為化二重盲検能動比較試験 Efficacy and safety of a 4-week course of repeated subcutaneous ketamine injections for treatment-resistant depression (KADS study): randomised double-blind active-controlled trial
Colleen Loo,Nick Glozier,David Barton,Bernhard T. Baune,Natalie T. Mills,Paul Fitzgerald,Paul Glue,Shanthi Sarma,Veronica Galvez-Ortiz,Dusan Hadzi-Pavlovic,Angelo Alonzo,Vanessa Dong,Donel Martin,Stevan Nikolin[,Philip B. Mitchell,Michael Berk,Gregory Carter,Maree Hackett,John Leyden,Sean Hood[,Andrew A. Somogyi,Kyle Lapidus,Elizabeth Stratton,Kirsten Gainsford,Deepak Garg,Nicollette L. R. Thornton,Célia Fourrier,Karyn Richardson,Demi Rozakis,Anish Scaria,Cathrine Mihalopoulos,Mary Lou Chatterton,William M. McDonald,Philip Boyce[],Paul E. Holtzheimer,F. Andrew Kozel,Patricio Riva-Posse and Anthony Rodgers
British Journal of Psychiatry Published:14 July 2023
DOI:https://doi.org/10.1192/bjp.2023.79
Abstract
Background
Prior trials suggest that intravenous racemic ketamine is a highly effective for treatment-resistant depression (TRD), but phase 3 trials of racemic ketamine are needed.
Aims
To assess the acute efficacy and safety of a 4-week course of subcutaneous racemic ketamine in participants with TRD. Trial registration: ACTRN12616001096448 at www.anzctr.org.au.
Method
This phase 3, double-blind, randomised, active-controlled multicentre trial was conducted at seven mood disorders centres in Australia and New Zealand. Participants received twice-weekly subcutaneous racemic ketamine or midazolam for 4 weeks. Initially, the trial tested fixed-dose ketamine 0.5 mg/kg versus midazolam 0.025 mg/kg (cohort 1). Dosing was revised, after a Data Safety Monitoring Board recommendation, to flexible-dose ketamine 0.5–0.9 mg/kg or midazolam 0.025–0.045 mg/kg, with response-guided dosing increments (cohort 2). The primary outcome was remission (Montgomery-Åsberg Rating Scale for Depression score ≤10) at the end of week 4.
Results
The final analysis (those who received at least one treatment) comprised 68 in cohort 1 (fixed-dose), 106 in cohort 2 (flexible-dose). Ketamine was more efficacious than midazolam in cohort 2 (remission rate 19.6% v. 2.0%; OR = 12.1, 95% CI 2.1–69.2, P = 0.005), but not different in cohort 1 (remission rate 6.3% v. 8.8%; OR = 1.3, 95% CI 0.2–8.2, P = 0.76). Ketamine was well tolerated. Acute adverse effects (psychotomimetic, blood pressure increases) resolved within 2 h.
Conclusions
Adequately dosed subcutaneous racemic ketamine was efficacious and safe in treating TRD over a 4-week treatment period. The subcutaneous route is practical and feasible.
