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77 Long-term Valbenazine Treatment in Patients with Schizophrenia/Schizoaffective Disorder or Mood Disorder and Tardive Dyskinesia
- Jean-Pierre Lindenmayer, Stephen R. Marder, Carlos Singer, Cynthia Comella, Khody Farahmand, Joshua Burke, Roland Jimenez, Scott Siegert
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- Journal:
- CNS Spectrums / Volume 24 / Issue 1 / February 2019
- Published online by Cambridge University Press:
- 12 March 2019, pp. 214-215
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Background
Patients treated with antipsychotics, regardless of psychiatric diagnosis, are at risk for developing tardive dyskinesia (TD), a potentially debilitating drug-induced movement disorder. Valbenazine (INGREZZA; VBZ) is a novel vesicular monoamine transporter 2 (VMAT2) inhibitor approved to treat TD in adults. Data from KINECT 4 (NCT02405091) were analyzed to evaluate the long-term effects of VBZ in adults with schizophrenia/schizoaffective disorder (SZD) or mood disorder (MD) and moderate or severe TD.
MethodsKINECT 4 included open-label treatment (48weeks) followed by washout (4weeks). Entry requirements included: moderate or severe TD, qualitatively assessed at screening by a blinded, external reviewer; DSM diagnosis of SZD or MD; psychiatric stability (Brief Psychiatric Rating Scale score <50). Stable concomitant psychiatric medications were allowed. Dosing was initiated at 40mg, with escalation to 80mg at Wk4 if participants had a Clinical Global Impression of Change-TD score of ≥3 (minimally improved to very much worse) and tolerated 40mg. A reduction to 40mg was allowed if 80mg was not tolerated (80/40mg); participants unable to tolerate 40mg were discontinued. Safety was the primary focus, but the Abnormal Involuntary Movement Scale (AIMS) total score (sum of items 1–7) was used to evaluate changes in TD. Mean changes from baseline (BL) in AIMS total score (rated by on-site investigators) were analyzed descriptively. Safety assessments included treatment-emergent adverse events (TEAEs) and psychiatric scales (Positive and Negative Syndrome Scale [PANSS], Calgary Depression Scale for Schizophrenia [CDSS], Montgomery-Åsberg Depression Rating Scale [MADRS], Young Mania Rating Scale [YMRS], and Columbia-Suicide Severity Rating Scale [C SSRS]).
ResultsOf 163 participants in the analyses, 103 completed the study. Adverse events (n=26) was the most common reason for discontinuation. Analyses included 119 participants with SZD (40mg=37; 80mg=76; 80/40mg=6) and 44 with MD (40mg=8; 80mg=31; 80/40mg=5). At Wk48, mean improvements from BL in AIMS total score were: SZD (40mg, –10.1; 80mg,–10.7); MD (40mg, 10.2; 80mg: –11.6). AIMS total scores at Wk52 (end of washout) indicated a return toward BL levels. Compared to SZD, the MD subgroup had a higher incidence of any TEAE (84% vs 61% [all doses]) but fewer TEAEs leading to discontinuation (7% vs 18%). Urinary tract infection was the most common TEAE in the MD subgroup (18%); somnolence and headache were most common in the SZD subgroup (7% each). Psychiatric status remained stable from BL to Wk48: SZD (PANSS positive, –0.7, PANSS negative, –0.6; CDSS, –0.7); MD (MADRS, –0.3; YMRS, –0.3). Most participants (95%) had no change in C-SSRS score during the study.
ConclusionSustained and clinically meaningful TD improvements were observed with VBZ, regardless of primary psychiatric diagnosis. VBZ was generally well tolerated and no notable changes in psychiatric status were observed.
Funding Acknowledgements: Supported by Neurocrine Biosciences, Inc.
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- By Mitchell Aboulafia, Frederick Adams, Marilyn McCord Adams, Robert M. Adams, Laird Addis, James W. Allard, David Allison, William P. Alston, Karl Ameriks, C. Anthony Anderson, David Leech Anderson, Lanier Anderson, Roger Ariew, David Armstrong, Denis G. Arnold, E. J. Ashworth, Margaret Atherton, Robin Attfield, Bruce Aune, Edward Wilson Averill, Jody Azzouni, Kent Bach, Andrew Bailey, Lynne Rudder Baker, Thomas R. Baldwin, Jon Barwise, George Bealer, William Bechtel, Lawrence C. Becker, Mark A. Bedau, Ernst Behler, José A. Benardete, Ermanno Bencivenga, Jan Berg, Michael Bergmann, Robert L. Bernasconi, Sven Bernecker, Bernard Berofsky, Rod Bertolet, Charles J. Beyer, Christian Beyer, Joseph Bien, Joseph Bien, Peg Birmingham, Ivan Boh, James Bohman, Daniel Bonevac, Laurence BonJour, William J. Bouwsma, Raymond D. Bradley, Myles Brand, Richard B. Brandt, Michael E. Bratman, Stephen E. Braude, Daniel Breazeale, Angela Breitenbach, Jason Bridges, David O. Brink, Gordon G. Brittan, Justin Broackes, Dan W. Brock, Aaron Bronfman, Jeffrey E. Brower, Bartosz Brozek, Anthony Brueckner, Jeffrey Bub, Lara Buchak, Otavio Bueno, Ann E. Bumpus, Robert W. Burch, John Burgess, Arthur W. Burks, Panayot Butchvarov, Robert E. Butts, Marina Bykova, Patrick Byrne, David Carr, Noël Carroll, Edward S. Casey, Victor Caston, Victor Caston, Albert Casullo, Robert L. Causey, Alan K. L. Chan, Ruth Chang, Deen K. Chatterjee, Andrew Chignell, Roderick M. Chisholm, Kelly J. Clark, E. J. Coffman, Robin Collins, Brian P. Copenhaver, John Corcoran, John Cottingham, Roger Crisp, Frederick J. Crosson, Antonio S. Cua, Phillip D. Cummins, Martin Curd, Adam Cureton, Andrew Cutrofello, Stephen Darwall, Paul Sheldon Davies, Wayne A. Davis, Timothy Joseph Day, Claudio de Almeida, Mario De Caro, Mario De Caro, John Deigh, C. F. Delaney, Daniel C. Dennett, Michael R. DePaul, Michael Detlefsen, Daniel Trent Devereux, Philip E. Devine, John M. Dillon, Martin C. 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Thomasson, Katherine Thomson-Jones, Joshua C. Thurow, Vzalerie Tiberius, Terrence N. Tice, Paul Tidman, Mark C. Timmons, William Tolhurst, James E. Tomberlin, Rosemarie Tong, Lawrence Torcello, Kelly Trogdon, J. D. Trout, Robert E. Tully, Raimo Tuomela, John Turri, Martin M. Tweedale, Thomas Uebel, Jennifer Uleman, James Van Cleve, Harry van der Linden, Peter van Inwagen, Bryan W. Van Norden, René van Woudenberg, Donald Phillip Verene, Samantha Vice, Thomas Vinci, Donald Wayne Viney, Barbara Von Eckardt, Peter B. M. Vranas, Steven J. Wagner, William J. Wainwright, Paul E. Walker, Robert E. Wall, Craig Walton, Douglas Walton, Eric Watkins, Richard A. Watson, Michael V. Wedin, Rudolph H. Weingartner, Paul Weirich, Paul J. Weithman, Carl Wellman, Howard Wettstein, Samuel C. Wheeler, Stephen A. White, Jennifer Whiting, Edward R. Wierenga, Michael Williams, Fred Wilson, W. Kent Wilson, Kenneth P. Winkler, John F. Wippel, Jan Woleński, Allan B. Wolter, Nicholas P. Wolterstorff, Rega Wood, W. Jay Wood, Paul Woodruff, Alison Wylie, Gideon Yaffe, Takashi Yagisawa, Yutaka Yamamoto, Keith E. Yandell, Xiaomei Yang, Dean Zimmerman, Günter Zoller, Catherine Zuckert, Michael Zuckert, Jack A. Zupko (J.A.Z.)
- Edited by Robert Audi, University of Notre Dame, Indiana
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- The Cambridge Dictionary of Philosophy
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- 05 August 2015
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- By Mowaffaq Almikhlafi, Osama Al-muslim, Robert Arntfield, Ian M Ball, Sue Berney, Mohit Bhutani, Clay A Block, Ken Blonde, Rudi Brits, Ron Butler, Lois Champion, Chris Clarke, Linda Denehy, Joseph Dreier, A Ebersohn, Shane W English, Ari Ercole, Darren H Freed, John Fuller, Julio P Zavala Georffino, RT Noel Gibney, Jeff Granton, Donald EG Griesdale, Arun K Gupta, Wael Haddara, Ahmed F Hegazy, Umjeet Singh Jolly, Philip M Jones, Ilya Kagan, Kala Kathirgamanathan, Harneet Kaur, John Kellett, Bhupesh Khadka, Biniam Kidane, Carlos Kidel, Anand Kumar, Alejandro Lazo-Langner, David Leasa, W Robert Leeper, Stephen Y Liang, Tania Ligori, Jaimie Manlucu, Janet Martin, Ian McConachie, Alan McGlennan, Lauralyn McIntyre, Tina Mele, MJ Naisbitt, Raj Nichani, Daniel H Ovakim, Neil Parry, Daniel Castro Pereira, Thomas Piraino, Brian Pollard, Valerie Schulz, Michael D Sharpe, Rohit K Singal, Pierre Singer, Mark Soth, Christian P Subbe, Jaffer Syed, Ravi Taneja, Tom Varughese, Jennifer Vergel Del Dios, Jessie R Welbourne, Christopher W White, Rebecca P Winsett, Titus C Yeung, G Bryan Young, Shelley R Zieroth
- Edited by John Fuller, University of Western Ontario, Jeff Granton, University of Western Ontario, Ian McConachie, University of Western Ontario
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- Handbook of ICU Therapy
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- 05 February 2015
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- 04 December 2014, pp vii-xii
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Chapter 10 - Nutrition
- from Section 1 - Basic principles
- Edited by John Fuller, University of Western Ontario, Jeff Granton, University of Western Ontario, Ian McConachie, University of Western Ontario
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- Handbook of ICU Therapy
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- 05 February 2015
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- 04 December 2014, pp 95-104
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7 - Nutritional supplements in critically ill patients
- from Section 2 - Nutritional Delivery and Dietetics
- Edited by Peter Faber, Mario Siervo, University of Newcastle upon Tyne
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- Nutrition in Critical Care
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- 05 April 2014
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- 06 March 2014, pp 67-72
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- By Bjarne F. Alsbjoern, Caroline M. Apovian, Danny Collins, Roland N. Dickerson, Timothy Eden, Peter Faber, Andrew J. Ferguson, David C. Frankenfield, Dympna Gallagher, Maria Gabriella Gentile, Wilson I. Gonsalves, Andrew M. Hetreed, Michael H. Hooper, Jan O. Jansen, Aminah Jatoi, Ying Ji, Ilya Kagan, Andrew J. Kerwin, Dong Wook Kim, Andrew A. Klein, Alistair Lee, Shaul Lev, Peter K. Linden, Paul E. Marik, Robert Martindale, Peter McCanny, Paolo Merlani, Shay Nanthakumaran, Michael S. Nussbaum, Andreas Perren, Carla Prado, Jean-Charles Preiser, Minha Rajput-Ray, Sumantra Ray, Nils Siegenthaler, Mario Siervo, Jonathan A. Silversides, Pierre Singer, John A. Tayek, Euan Thomson, Krista L. Turner, Malissa Warren, Stephen T. Webb, Patricia Wiesen
- Edited by Peter Faber, Mario Siervo, University of Newcastle upon Tyne
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- Nutrition in Critical Care
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- 05 April 2014
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- 06 March 2014, pp viii-xii
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- By Adam K. Anderson, Jorge Armony, Anthony P. Atkinson, Sonia Bishop, Carolin Brück, Roberto Cabeza, Frances S. Chen, Hugo D. Critchley, Mauricio R. Delgado, Ricardo de Oliveira-Souza, Gregor Domes, Judith Domínguez-Borràs, Joseph E. Dunsmoor, Thomas Ethofer, Dominic S. Fareri, Lesley K. Fellows, Sophie Forster, Katherine Gardhouse, Nathalie George, Jay A. Gottfried, Jung Eun Han, Ahmad R. Hariri, Neil A. Harrison, Markus Heinrichs, Alisha C. Holland, Andreas Keil, Elizabeth A. Kensinger, Johanna Kissler, Olga Klimecki, Stefan Koelsch, Sylvia D. Kreibig, Benjamin Kreifelts, Robert Kumsta, Kevin S. LaBar, Eamon J. McCrory, Aprajita Mohanty, Jorge Moll, John P. O’Doherty, Leticia Oliveira, Mirtes Pereira, Luiz Pessoa, K. Luan Phan, Pierre Rainville, David Sander, Annett Schirmer, Catherine L. Sebastian, Tania Singer, Chandra Sekhar Sripada, Peggy L. St. Jacques, Essi Viding, Patrik Vuilleumier, Dirk Wildgruber, Amy Winecoff, Roland Zahn
- Edited by Jorge Armony, McGill University, Montréal, Patrik Vuilleumier, Université de Genève
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- The Cambridge Handbook of Human Affective Neuroscience
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- 05 February 2013
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- 21 January 2013, pp xi-xii
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Enteral n-3 fatty acids and micronutrients enhance percentage of positive neutrophil and lymphocyte adhesion molecules: a potential mediator of pressure ulcer healing in critically ill patients
- Miriam Theilla, Betty Schwartz, Yael Zimra, Haim Shapiro, Ronit Anbar, Esther Rabizadeh, Jonathan Cohen, Pierre Singer
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- British Journal of Nutrition / Volume 107 / Issue 7 / 14 April 2012
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- 01 November 2011, pp. 1056-1061
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- 14 April 2012
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n-3 Fatty acids are recognised as influencing both wound healing and immunity. We assessed the impact of a fish oil- and micronutrient-enriched formula (study formula) on the healing of pressure ulcers and on immune function in critically ill patients in an intensive care unit. A total of forty patients with pressure ulcers and receiving nutritional support were enrolled (intervention group, n 20, received study formula; and a control group, n 20, received an isoenergetic formula). Total and differential leucocyte count and percentage of adhesion molecule positive granulocyte and lymphocyte cells (CD11a, CD11b, CD18 and CD49b) were measured on days 0, 7 and 14. Percentage of positive lymphocytes for CD54, CD49b, CD49d and CD8 were also measured on days 0, 7 and 14. The state of pressure ulcers was assessed by using the pressure ulcer scale for healing tool score on days 7, 14 and 28 of treatment. No between-group differences in patient demographics, anthropometry or diagnostic class were observed. Patients who received the study formula showed significant increases in the percentage of positive CD18 and CD11a lymphocytes and of CD49b granulocytes as compared to controls (P < 0·05). While the severity of pressure ulcers was not significantly different between the two groups on admission, severity increased significantly over time for the control group (P < 0·05), but not for the study group. The present study suggests that a fish oil- and micronutrient-enriched formula may prevent worsening of pressure ulcers and that this effect may be mediated by an effect on adhesion molecule expression.