4 results
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, Anthony Rodgers
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- Journal:
- The British Journal of Psychiatry / Volume 223 / Issue 6 / December 2023
- Published online by Cambridge University Press:
- 14 July 2023, pp. 533-541
- Print publication:
- December 2023
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- Article
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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.
AimsTo 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.
MethodThis 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.
ResultsThe 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.
ConclusionsAdequately dosed subcutaneous racemic ketamine was efficacious and safe in treating TRD over a 4-week treatment period. The subcutaneous route is practical and feasible.
Contributors
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- By Lenard A. Adler, Pinky Agarwal, Rehan Ahmed, Jagga Rao Alluri, Fawaz Al-Mufti, Samuel Alperin, Michael Amoashiy, Michael Andary, David J. Anschel, Padmaja Aradhya, Vandana Aspen, Esther Baldinger, Jee Bang, George D. Baquis, John J. Barry, Jason J. S. Barton, Julius Bazan, Amanda R. Bedford, Marlene Behrmann, Lourdes Bello-Espinosa, Ajay Berdia, Alan R. Berger, Mark Beyer, Don C. Bienfang, Kevin M. Biglan, Thomas M. Boes, Paul W. Brazis, Jonathan L. Brisman, Jeffrey A. Brown, Scott E. Brown, Ryan R. Byrne, Rina Caprarella, Casey A. Chamberlain, Wan-Tsu W. Chang, Grace M. Charles, Jasvinder Chawla, David Clark, Todd J. Cohen, Joe Colombo, Howard Crystal, Vladimir Dadashev, Sarita B. Dave, Jean Robert Desrouleaux, Richard L. Doty, Robert Duarte, Jeffrey S. Durmer, Christyn M. Edmundson, Eric R. Eggenberger, Steven Ender, Noam Epstein, Alberto J. Espay, Alan B. Ettinger, Niloofar (Nelly) Faghani, Amtul Farheen, Edward Firouztale, Rod Foroozan, Anne L. Foundas, David Elliot Friedman, Deborah I. Friedman, Steven J. Frucht, Oded Gerber, Tal Gilboa, Martin Gizzi, Teneille G. Gofton, Louis J. Goodrich, Malcolm H. Gottesman, Varda Gross-Tsur, Deepak Grover, David A. Gudis, John J. Halperin, Maxim D. Hammer, Andrew R. Harrison, L. Anne Hayman, Galen V. Henderson, Steven Herskovitz, Caitlin Hoffman, Laryssa A. Huryn, Andres M. Kanner, Gary P. Kaplan, Bashar Katirji, Kenneth R. Kaufman, Annie Killoran, Nina Kirz, Gad E. Klein, Danielle G. Koby, Christopher P. Kogut, W. Curt LaFrance, Patrick J.M. Lavin, Susan W. Law, James L. Levenson, Richard B. Lipton, Glenn Lopate, Daniel J. Luciano, Reema Maindiratta, Robert M. Mallery, Georgios Manousakis, Alan Mazurek, Luis J. Mejico, Dragana Micic, Ali Mokhtarzadeh, Walter J. Molofsky, Heather E. Moss, Mark L. Moster, Manpreet Multani, Siddhartha Nadkarni, George C. Newman, Rolla Nuoman, Paul A. Nyquist, Gaia Donata Oggioni, Odi Oguh, Denis Ostrovskiy, Kristina Y. Pao, Juwen Park, Anastas F. Pass, Victoria S. Pelak, Jeffrey Peterson, John Pile-Spellman, Misha L. Pless, Gregory M. Pontone, Aparna M. Prabhu, Michael T. Pulley, Philip Ragone, Prajwal Rajappa, Venkat Ramani, Sindhu Ramchandren, Ritesh A. Ramdhani, Ramses Ribot, Heidi D. Riney, Diana Rojas-Soto, Michael Ronthal, Daniel M. Rosenbaum, David B. Rosenfield, Durga Roy, Michael J. Ruckenstein, Max C. Rudansky, Eva Sahay, Friedhelm Sandbrink, Jade S. Schiffman, Angela Scicutella, Maroun T. Semaan, Robert C. Sergott, Aashit K. Shah, David M. Shaw, Amit M. Shelat, Claire A. Sheldon, Anant M. Shenoy, Yelizaveta Sher, Jessica A. Shields, Tanya Simuni, Rajpaul Singh, Eric E. Smouha, David Solomon, Mehri Songhorian, Steven A. Sparr, Egilius L. H. Spierings, Eve G. Spratt, Beth Stein, S.H. Subramony, Rosa Ana Tang, Cara Tannenbaum, Hakan Tekeli, Amanda J. Thompson, Michael J. Thorpy, Matthew J. Thurtell, Pedro J. Torrico, Ira M. Turner, Scott Uretsky, Ruth H. Walker, Deborah M. Weisbrot, Michael A. Williams, Jacques Winter, Randall J. Wright, Jay Elliot Yasen, Shicong Ye, G. Bryan Young, Huiying Yu, Ryan J. Zehnder
- Edited by Alan B. Ettinger, Albert Einstein College of Medicine, New York, Deborah M. Weisbrot, State University of New York, Stony Brook
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- Book:
- Neurologic Differential Diagnosis
- Published online:
- 05 June 2014
- Print publication:
- 17 April 2014, pp xi-xx
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Contributors
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- By Krista Adamek, Ana Luisa K. Albernaz, J. Marcio Ayres†, Andrew J. Baker, Karen L. Bales, Adrian A. Barnett, Christopher Barton, John M. Bates, Jennie Becker, Bruna M. Bezerra, Júlio César Bicca-Marques, Richard Bodmer, Jean P. Boubli, Mark Bowler, Sarah A. Boyle, Christini Barbosa Caselli, Janice Chism, Elena P. Cunningham, José Maria C. da Silva, Lesa C. Davies, Nayara de Alcântara Cardoso, Manuella A. de Souza, Stella de la Torre, Ana Gabriela de Luna, Thomas R. Defler, Anthony Di Fiore, Eduardo Fernandez-Duque, Stephen F. Ferrari, Wilsea M.B. Figueiredo-Ready, Tracy Frampton, Paul A. Garber, Brian W. Grafton, L. Tremaine Gregory, Maria L. Harada, Amy Harrison-Levine, Walter C. Hartwig, Stefanie Heiduck, Eckhard W. Heymann, André Hirsch, Leandro Jerusalinsky, Gareth Jones, Richard F. Kay, Martin M. Kowalewski, Shawn M. Lehman, Laura Marsh, Jesús Martinez, William A. Mason, Hope Matthews, Wynlyn McBride, Shona McCann-Wood, W. Scott McGraw, D. Jeffrey Meldrum, Sally P. Mendoza, Nohelia Mercado, Russell A. Mittermeier, Mirjam N. Nadjafzadeh, Marilyn A. Norconk, Robert Gary Norman, Marcela Oliveira, Marcelo M. Oliveira, Maria Juliana Ospina Rodríguez, Erwin Palacios, Suzanne Palminteri, Liliam P. Pinto, Marcio Port-Carvalho, Leila Porter, Carlos Portillo-Quintero, George Powell, Ghillean T. Prance, Rodrigo C. Printes, Pablo Puertas, P. Kirsten Pullen, Helder L. Queiroz, Luis Reginaldo R. Rodrigues, Adriana Rodríguez, Alfred L. Rosenberger, Anthony B. Rylands, Ricardo R. Santos, Horacio Schneider, Eleonore Z.F. Setz, Suleima S.B. Silva, José S. Silva Júnior, Andrew T. Smith, Marcelo C. Sousa, Antonio S. Souto, Wilson R. Spironello, Masanaru Takai, Marcelo F. Tejedor, Cynthia L. Thompson, Diego G. Tirira, Raul Tupayachi, Bernardo Urbani, Liza M. Veiga, Marianela Velilla, João Valsecchi, Jean-Christophe Vié, Tatiana M. Vieira, Suzanne E. Walker-Pacheco, Rob Wallace, Patricia C. Wright, Charles E. Zartman
- Edited by Liza M. Veiga, Universidade Federal do Pará, Brazil, Adrian A. Barnett, Roehampton University, London, Stephen F. Ferrari, Universidade Federal de Sergipe, Brazil, Marilyn A. Norconk, Kent State University, Ohio
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- Book:
- Evolutionary Biology and Conservation of Titis, Sakis and Uacaris
- Published online:
- 05 April 2013
- Print publication:
- 11 April 2013, pp xii-xv
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12 - Community responses to disaster: the Gander plane crash
- from Part III - The role of psychosocial context in responses to trauma and disasters
- Edited by Robert J. Ursano, Uniformed Services University of the Health Sciences, Maryland, Brian G. McCaughey, Uniformed Services University of the Health Sciences, Maryland, Carol S. Fullerton, Uniformed Services University of the Health Sciences, Maryland
- Foreword by Beverley Raphael
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- Book:
- Individual and Community Responses to Trauma and Disaster
- Published online:
- 13 October 2009
- Print publication:
- 24 February 1994, pp 267-284
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Summary
Several theoretical approaches or models are available to those interested in studying community responses to disaster and trauma. Unfortunately, recent experience with disasters proves that these models are overly restrictive. This chapter draws on observations following a major military air disaster to develop a new, expanded model of the impact on communities from such events. This model avoids the key restrictions of earlier models.
One critical restriction of community disaster models is the principal level of analysis that is adopted. Some models focus on individuals within the community, and aggregate individual reactions to form a picture of community response. Others view the community as a social unit that must be considered as a separate entity. These different views are usually assumed to be mutually exclusive, leading to a debate over which is more correct (Melick, 1985; Quarantelli, 1985; Powell & Penick, 1983; Tierney, 1986).
Tierney (1986) summarizes the controversy about theoretical orientation. Each orientation focuses either on a group or an individual level of analysis to the exclusion of the other. Those researchers who assume a community perspective conclude that psychological effects following disaster are minimal and short term, and that poor outcomes arise from inadequate disaster planning and resources on the part of community organizations (Quarantelli, 1985). The alternative orientation is a ‘psychological trauma’ perspective. It concludes that the catastrophic nature of the event and the subsequent trauma of dealing with the experience and its aftermath result in significant, adverse, and typically long-term psychological effects (Erikson, 1976; Lifton & Olson, 1976).