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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.
Loo, Colleen; Glozier, Nick; Barton, David; Baune, Bernhard T; Mills, Natalie T; Fitzgerald, Paul; Glue, Paul; Sarma, Shanthi; Galvez-Ortiz, Veronica; Hadzi-Pavlovic, Dusan; Alonzo, Angelo; Dong, Vanessa; Martin, Donel; Nikolin, Stevan; Mitchell, Philip B; Berk, Michael; Carter, Gregory; Hackett, Maree; Leyden, John; Hood, Sean; Somogyi, Andrew A; Lapidus, Kyle; Stratton, Elizabeth; Gainsford, Kirsten; Garg, Deepak; Thornton, Nicollette L R; Fourrier, Célia; Richardson, Karyn; Rozakis, Demi; Scaria, Anish; Mihalopoulos, Cathrine; Chatterton, Mary Lou; McDonald, William M; Boyce, Philip; Holtzheimer, Paul E; Kozel, F Andrew; Riva-Posse, Patricio; Rodgers, Anthony.
Afiliação
  • Loo C; Black Dog Institute, University of New South Wales, Randwick, New South Wales, Australia; and George Institute for Global Health, Newtown, New South Wales, Australia.
  • Glozier N; Central Clinical School, Faculty of Medicine and Health, University of Sydney, Sydney, New South Wales, Australia; and Australian Research Council Centre of Excellence for Children and Families over the Life Course, University of Sydney, Sydney, New South Wales, Australia.
  • Barton D; Australian Centre for Heart Health, Royal Melbourne Hospital, North Melbourne, Victoria, Australia; and NeuroCentrix, South Carlton, Victoria, Australia.
  • Baune BT; Department of Psychiatry, University of Münster, Münster, Germany; Department of Psychiatry, Melbourne Medical School, University of Melbourne, Melbourne, Victoria, Australia; and Florey Institute of Neuroscience and Mental Health, Parkville, Victoria, Australia.
  • Mills NT; Discipline of Psychiatry, University of Adelaide, Adelaide, South Australia, Australia.
  • Fitzgerald P; Australian National University School of Medicine and Psychology, Canberra, Australian Capital Territory, Australia.
  • Glue P; Dunedin School of Medicine, University of Otago, Dunedin, New Zealand.
  • Sarma S; Mental Health and Specialist Services, Gold Coast Health, Bond University, Robina, Queensland, Australia.
  • Galvez-Ortiz V; Department of Psychiatry and Mental Health, Hospital Universitari Parc Tauli, Sabadell, Spain; and Institut Investigacio I Innovacio Parc Tauli, Sabadell, Spain.
  • Hadzi-Pavlovic D; Discipline of Psychiatry and Mental Health, University of New South Wales, Sydney, New South Wales, Australia.
  • Alonzo A; Discipline of Psychiatry and Mental Health, University of New South Wales, Sydney, New South Wales, Australia; University of New South Wales, Randwick, New South Wales, Australia; and George Institute for Global Health, Newtown, New South Wales, Australia.
  • Dong V; Discipline of Psychiatry and Mental Health, University of New South Wales, Sydney, New South Wales, Australia; University of New South Wales, Randwick, New South Wales, Australia; and George Institute for Global Health, Newtown, New South Wales, Australia.
  • Martin D; Discipline of Psychiatry and Mental Health, University of New South Wales, Sydney, New South Wales, Australia; University of New South Wales, Randwick, New South Wales, Australia; and George Institute for Global Health, Newtown, New South Wales, Australia.
  • Nikolin S; Discipline of Psychiatry and Mental Health, University of New South Wales, Sydney, New South Wales, Australia; University of New South Wales, Randwick, New South Wales, Australia; and George Institute for Global Health, Newtown, New South Wales, Australia.
  • Mitchell PB; Discipline of Psychiatry and Mental Health, University of New South Wales, Sydney, New South Wales, Australia.
  • Berk M; Institute for Mental and Physical Health and Clinical Translation (IMPACT), School of Medicine, Barwon Health, Deakin University, Geelong, Australia.
  • Carter G; College of Health, Medicine and Wellbeing, School of Medicine and Public Health, University of Newcastle, Callaghan, New South Wales, Australia.
  • Hackett M; George Institute for Global Health, Newtown, New South Wales, Australia.
  • Leyden J; Royal North Shore Hospital, St Leonards, New South Wales, Australia; and Northern Sydney Anaesthetic Research Institute, St Leonards, New South Wales, Australia.
  • Hood S; Division of Psychiatry, University of Western Australia, Perth, Western Australia, Australia.
  • Somogyi AA; Discipline of Pharmacology, School of Biomedicine, Faculty of Health and Medical Sciences, University of Adelaide, Adelaide, Australia.
  • Lapidus K; Affective Care, Northwell Health, New York, New York, USA.
  • Stratton E; Faculty of Medicine and Health, Central Clinical School, University of Sydney, Sydney, New South Wales, Australia.
  • Gainsford K; Epworth Centre for Innovation in Mental Health, Epworth Healthcare and Monash University, Camberwell, Victoria, Australia.
  • Garg D; Mental Health and Specialist Services, Gold Coast Health, Bond University, Robina, Queensland, Australia.
  • Thornton NLR; Central Clinical School, Faculty of Medicine and Health, University of Sydney, Sydney, New South Wales, Australia; and Australian Research Council Centre of Excellence for Children and Families over the Life Course, University of Sydney, Sydney, New South Wales, Australia.
  • Fourrier C; Discipline of Psychiatry, University of Adelaide, Adelaide, South Australia, Australia; and Lysosomal Health in Ageing, Hopwood Centre for Neurobiology, South Australian Health and Medical Research Institute, Adelaide, South Australia, Australia.
  • Richardson K; BrainPark, Turner Institute for Brain and Mental Health, Monash University, Clayton, Victoria, Australia; and Epworth Centre for Innovation in Mental Health, Epworth Healthcare and Monash University, Camberwell, Victoria, Australia.
  • Rozakis D; NeuroCentrix, Noble Park, Victoria, Australia.
  • Scaria A; George Institute for Global Health, Newtown, New South Wales, Australia.
  • Mihalopoulos C; School of Public Health and Preventive Medicine, Monash University, Melbourne, Victoria, Australia; and School of Health and Social Development, Deakin University, Geelong, Australia.
  • Chatterton ML; School of Public Health and Preventive Medicine, Monash University, Melbourne, Victoria, Australia.
  • McDonald WM; Department of Psychiatry and Behavioral Sciences, Emory University School of Medicine, Atlanta, Georgia, USA.
  • Boyce P; Specialty of Psychiatry, Westmead Institute of Medical Research, Faculty of Medicine and Health, University of Sydney, Sydney, New South Wales, Australia.
  • Holtzheimer PE; Department of Psychiatry, Geisel School of Medicine at Dartmouth, Lebanon, New Hampshire, USA; and Department of Surgery, Geisel School of Medicine at Dartmouth, Lebanon, New Hampshire, USA.
  • Kozel FA; Department of Behavioral Sciences and Social Medicine, Florida State University College of Medicine, Tallahassee, Florida, USA.
  • Riva-Posse P; Department of Psychiatry and Behavioral Sciences, Emory University School of Medicine, Atlanta, Georgia, USA.
  • Rodgers A; George Institute for Global Health, Newtown, New South Wales, Australia.
Br J Psychiatry ; 223(6): 533-541, 2023 12.
Article em En | MEDLINE | ID: mdl-38108319
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.
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Texto completo: 1 Base de dados: MEDLINE Assunto principal: Transtorno Depressivo Resistente a Tratamento / Ketamina Limite: Humans País/Região como assunto: Oceania Idioma: En Revista: Br J Psychiatry Ano de publicação: 2023 Tipo de documento: Article País de afiliação: Austrália
Texto completo
Imprimir
XML
PubMed Links
Buscar no Google

Texto completo: 1 Base de dados: MEDLINE Assunto principal: Transtorno Depressivo Resistente a Tratamento / Ketamina Limite: Humans País/Região como assunto: Oceania Idioma: En Revista: Br J Psychiatry Ano de publicação: 2023 Tipo de documento: Article País de afiliação: Austrália