4 results
A Placebo-Controlled Study Evaluating the Efficacy and Safety of Flexible-Dose Desvenlafaxine Treatment in Outpatients with Major Depressive Disorder
- Alan D. Feiger, Karen A. Tourian, Gregory R. Rosas, S. Krishna Padmanabhan
-
- Journal:
- CNS Spectrums / Volume 14 / Issue 1 / January 2009
- Published online by Cambridge University Press:
- 07 November 2014, pp. 41-50
-
- Article
- Export citation
-
Introduction: This research compares the efficacy and safety of desvenlafaxine (administered as desvenlafaxine succinate) versus placebo in treating major depressive disorder.
Methods: In this randomized, double-blind study, outpatients with major depressive disorder ≥18 years of age received desvenlafaxine 200–400 mg/day or placebo for 8 weeks. Efficacy endpoints included (primary) change in 17-item Hamilton Rating Scale for Depression score at the final evaluation (last observation carried forward, analysis of covariance) and (secondary) Clinical Global Impressions—Improvement and—Severity of Illness scales.
Results: The difference between desvenlafaxine (n=117) and placebo (n=118) on the primary endpoint was not significant (−9.1 vs −7.5, P=.078). Week 8 observed cases (desvenlafaxine, n=80; placebo, n=94) results were significant (−10.7 vs −7.9, P=.008). Differences at the final evaluation (last observation carried forward) were significant for Clinical Global Impressions—Improvement (2.9 vs 2.5, P=.037) and Clinical Global Impressions—Severity of Illness (−1.9 vs −1.2, P=.041). Discontinuation rates due to adverse events (AEs) were 12% and 3% for desvenlafaxine and placebo, respectively (P=.008). The most frequently reported AE associated with desvenlafaxine was nausea (36% vs 9% [placebo]).
Conclusion: In this study, the primary analysis did not show significant differences between desvenlafaxine and placebo; discontinuations due to AEs associated with the desvenlafaxine dose range may have contributed to the lack of statistical separation.
Contributors
-
- 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
-
- Book:
- Neurologic Differential Diagnosis
- Published online:
- 05 June 2014
- Print publication:
- 17 April 2014, pp xi-xx
-
- Chapter
- Export citation
High-dose desvenlafaxine in outpatients with major depressive disorder
- James M. Ferguson, Karen A. Tourian, Gregory R. Rosas
-
- Journal:
- CNS Spectrums / Volume 17 / Issue 3 / September 2012
- Published online by Cambridge University Press:
- 10 August 2012, pp. 121-130
-
- Article
- Export citation
-
Objective
This study investigated the safety and efficacy of long-term treatment with high-dose desvenlafaxine (administered as desvenlafaxine succinate) in major depressive disorder (MDD).
MethodsIn this multicenter, open-label study, adult outpatients with MDD aged 18–75 were treated with flexible doses of desvenlafaxine (200–400 mg/d) for ≤ 1 year. Safety assessments included monitoring of treatment-emergent adverse events (TEAEs), patient discontinuations due to adverse events, electrocardiograms, vital signs, and laboratory determinations. The primary efficacy measure was mean change from baseline in the 17-item Hamilton Rating Scale for Depression [HAM-D(17)] total score.
ResultsThe mean daily desvenlafaxine dose range over the duration of the trial was 267–356 mg (after titration). The most frequent TEAEs in the safety population (n = 104) were nausea (52%) and headache (41%), dizziness (31%), insomnia (29%), and dry mouth (27%). All TEAEs were mild or moderate in severity. Thirty-four (33%) patients discontinued from the study because of TEAEs; nausea (12%) and dizziness (9%) were the most frequently cited reasons. The mean change in HAM-D(17) total score for the intent-to-treat population (n = 99) was −9.9 at the last on-therapy visit in the last-observation-carried-forward analysis and −14.0 at month 12 in the observed cases analysis.
ConclusionHigh-dose desvenlafaxine (200–400 mg/d) was generally safe and effective in the long-term treatment of MDD.
Contributors
-
- By Shamsuddin Akhtar, Greg Albert, Sidney Allison, Muhammad Anwar, Haruo Arita, Amanda Barker, Mary Hanna Bekhit, Jeanna Blitz, Tyson Bolinske, David Burbulys, Asokumar Buvanendran, Gregory Cain, Keith A. Candiotti, Daniel B. Carr, Derek Chalmers, John Charney, Rex Cheng, Roger Chou, Keun Sam Chung, Anna Clebone, Frederick Conlin, Susan Dabu-Bondoc, Tiffany Denepitiya-Balicki, Jeanette Derdemezi, Anahat Kaur Dhillon, Ho Dzung, Juan Jose Egas, Stephen M. Eskaros, Zhuang T. Fang, Claudia R. Fernandez Robles, Victor A. Filadora, Ellen Flanagan, Dan Froicu, Allison Gandey, Nehal Gatha, Boris Gelman, Christopher Gharibo, Muhammad K. Ghori, Brian Ginsberg, Michael E. Goldberg, Jeff Gudin, Thomas Halaszynski, Martin Hale, Dorothea Hall, Craig T. Hartrick, Justin Hata, Lars E. Helgeson, Joe C. Hong, Richard W. Hong, Balazs Horvath, Eric S. Hsu, Gabriel Jacobs, Jonathan S. Jahr, Rongjie Jaing, Inderjeet Singh Julka, Zeev N. Kain, Clinton Kakazu, Kianusch Kiai, Mary Keyes, Michael M. Kim, Peter G. Lacouture, Ryan Lanier, Vivian K. Lee, Mark J. Lema, Oscar A. de Leon-Casasola, Imanuel Lerman, Philip Levin, Steven Levin, JinLei Li, Eric C. Lin, Sharon Lin, David A. Lindley, Ana M. Lobo, Marisa Lomanto, Mirjana Lovrincevic, Brenda C. McClain, Tariq Malik, Jure Marijic, Joseph Marino, Laura Mechtler, Alan Miller, Carly Miller, Amit Mirchandani, Sukanya Mitra, Fleurise Montecillo, James M. Moore, Debra E. Morrison, Philip F. Morway, Carsten Nadjat-Haiem, Hamid Nourmand, Dana Oprea, Sunil J. Panchal, Edward J. Park, Kathleen Ji Park, Kellie Park, Parisa Partownavid, Akta Patel, Bijal Patel, Komal D. Patel, Neesa Patel, Swati Patel, Paul M. Peloso, Danielle Perret, Anthony DePlato, Marjorie Podraza Stiegler, Despina Psillides, Mamatha Punjala, Johan Raeder, Siamak Rahman, Aziz M. Razzuk, Maggy G. Riad, Kristin L. Richards, R. Todd Rinnier, Ian W. Rodger, Joseph Rosa, Abraham Rosenbaum, Alireza Sadoughi, Veena Salgar, Leslie Schechter, Michael Seneca, Yasser F. Shaheen, James H. Shull, Elizabeth Sinatra, Raymond S. Sinatra, Neil Singla, Neil Sinha, Denis V. Snegovskikh, Dmitri Souzdalnitski, Julie Sramcik, Zoreh Steffens, Alexander Timchenko, Vadim Tokhner, Marc C. Torjman, Co T. Truong, Nalini Vadivelu, Ashley Vaughn, Anjali Vira, Eugene R. Viscusi, Dajie Wang, Shu-ming Wang, J. Michael Watkins-Pitchford, Steven J. Weisman, Ira Whitten, Bryan S. Williams, Jeremy M. Wong, Thomas Wong, Christopher Wray, Yaw Wu, Anthony T. Yarussi, Laurie Yonemoto, Bita H. Zadeh, Jill Zafar, Martha Zegarra, Keren Ziv
- Edited by Raymond S. Sinatra, Jonathan S. Jahr, University of California, Los Angeles, School of Medicine, J. Michael Watkins-Pitchford
-
- Book:
- The Essence of Analgesia and Analgesics
- Published online:
- 06 December 2010
- Print publication:
- 14 October 2010, pp xi-xviii
-
- Chapter
- Export citation