TY - JOUR
T1 - Randomized comparison of selective serotonin reuptake inhibitor (escitalopram) monotherapy and antidepressant combination pharmacotherapy for major depressive disorder with melancholic features
T2 - A CO-MED report
AU - Bobo, William V.
AU - Chen, Helen
AU - Trivedi, Madhukar H.
AU - Stewart, Jonathan W.
AU - Nierenberg, Andrew A.
AU - Fava, Maurizio
AU - Kurian, Benji T.
AU - Warden, Diane
AU - Morris, David W.
AU - Luther, James F.
AU - Husain, Mustafa M.
AU - Cook, Ian A.
AU - Lesser, Ira M.
AU - Kornstein, Susan G.
AU - Wisniewski, Stephen R.
AU - Rush, A. John
AU - Shelton, Richard C.
N1 - Funding Information:
William V. Bobo, MD, MPH, has received research/grant support from Cephalon, Inc., the National Alliance for Research on Schizophrenia and Depression (NARSAD), and the National Institute of Mental Health (NIMH); and has served in the past on speaker bureaus for Janssen Pharmaceutica and Pfizer, Inc.
Funding Information:
Ian A. Cook, MD, has served as an advisor and consultant for Ascend Media, Bristol-Myers Squibb, Cyb eronics, Janssen Pharmaceutica, NeuroSigma, and the U.S. Departments of Defense and of Justice. He has served on the speaker bureaus for Bristol-Myers Squibb, Neuronetics, and Wyeth/Pfizer. He has received research support from Aspect Medical Systems/Covidien, Cyberonics, Eli Lilly and Company, Neuronetics, Novartis, Pfizer, Sepracor, and the National Institutes of Health. His patents on biomedical devices are assigned to the Regents of the University of California.
Funding Information:
Ira M. Lesser, MD, has received research support from the National Institute of Mental Health and Aspect Medical System/Covidian.
Funding Information:
Benji T. Kurian, MD, has received research support from Targacept, Inc., and Pfizer, Inc.
Funding Information:
Richard C. Shelton, MD, has served as a consultant for Eli Lilly and Company, Evotec AG, Forest Pharmaceuticals, Gideon Richter PLC, Janssen Pharmaceutica, Medronic, Inc., Otsuka Pharmaceuticals, Pamlab, Inc., Pfizer, Inc., Repligen, Inc., and Sierra Neuropharmaceuticals. He has received research support from Eli Lilly and Company, Forest Pharmaceuticals, Janssen Pharmaceutica, Novartis Pharmaceuticals, Otsuka Pharmaceuticals, Pamlab, Pfizer, Inc., Repligen, Inc., and St. Jude Medical.
Funding Information:
This project was funded by the National Institute of Mental Health under Contract N01MH90003 to UT Southwestern Medical Center at Dallas (PIs A.J. Rush, M.H. Trivedi). The content of this publication does not necessarily reflect the views or policies of the Department of Health and Human Services, nor does mention of trade names, commercial products, or organizations imply endorsement by the U. S. Government. The NIMH had no role in the drafting or review of the manuscript, nor in the collection or analysis of the data.
Funding Information:
Susan G. Kornstein, MD, has served as a consultant for Bristol-Myers Squibb, Forest Laboratories, Eli Lilly and Company, Pfizer, Inc., Rexahn, Dey Pharma, PGxhealth, Takeda, and Wyeth. She has received research support from the National Institute of Mental Health, Boehringer-Ingelheim, Bristol-Myers Squibb, Eli Lilly and Company, Forest Laboratories, Wyeth, Novartis, Pfizer, Inc., Otsuka, and Takeda. She has received book royalties from Guildord Press.
PY - 2011/10
Y1 - 2011/10
N2 - Background: The clinical effects of antidepressant combinations vs. monotherapy as initial treatment for major depression with melancholic features (MDD-MF) are unknown. Methods: Outpatients with chronic or recurrent major depression (MDD) were randomized to initial treatment with escitalopram + placebo (the MONO condition), bupropion-sustained release + escitalopram, or venlafaxine-extended release + mirtazapine (the COMB conditions) in the Combining Medications to Enhance Depression Outcomes (CO-MED) trial. Secondary data analyses were conducted to compare demographic and clinical characteristics, and contrast clinical responses according to drug treatment, in patients with MDD-MF (n = 124) and non-melancholic MDD (n = 481). Results: While numerically lower, remission rates in MDD-MF did not differ significantly from those with non-melancholic MDD either at 12 (33.1% vs. 41.0%, aOR 1.16, p = 0.58) or 28 (39.5% vs. 46.8%, aOR = 1.02, p = 0.93) weeks of treatment. Remission rates did not differ significantly between combination and monotherapy groups in either MDD-MF or non-melancholic MDD patients at either time point. Similar conclusions were reached for response rates, premature study discontinuation, and self-rated depression symptom severity. Limitations: This is a secondary analysis of data from the CO-MED trial, which was not designed to address differential treatment response in melancholic and non-melancholic MDD. Conclusions: We found no evidence of differential remission or response rates to antidepressant combination or monotherapy between melancholic/non-melancholic MDD patients, or according to antidepressant treatment group, after 12 and 28 weeks. Melancholic features may not be a valid predictor of more favorable response to antidepressant combination therapy as initial treatment.
AB - Background: The clinical effects of antidepressant combinations vs. monotherapy as initial treatment for major depression with melancholic features (MDD-MF) are unknown. Methods: Outpatients with chronic or recurrent major depression (MDD) were randomized to initial treatment with escitalopram + placebo (the MONO condition), bupropion-sustained release + escitalopram, or venlafaxine-extended release + mirtazapine (the COMB conditions) in the Combining Medications to Enhance Depression Outcomes (CO-MED) trial. Secondary data analyses were conducted to compare demographic and clinical characteristics, and contrast clinical responses according to drug treatment, in patients with MDD-MF (n = 124) and non-melancholic MDD (n = 481). Results: While numerically lower, remission rates in MDD-MF did not differ significantly from those with non-melancholic MDD either at 12 (33.1% vs. 41.0%, aOR 1.16, p = 0.58) or 28 (39.5% vs. 46.8%, aOR = 1.02, p = 0.93) weeks of treatment. Remission rates did not differ significantly between combination and monotherapy groups in either MDD-MF or non-melancholic MDD patients at either time point. Similar conclusions were reached for response rates, premature study discontinuation, and self-rated depression symptom severity. Limitations: This is a secondary analysis of data from the CO-MED trial, which was not designed to address differential treatment response in melancholic and non-melancholic MDD. Conclusions: We found no evidence of differential remission or response rates to antidepressant combination or monotherapy between melancholic/non-melancholic MDD patients, or according to antidepressant treatment group, after 12 and 28 weeks. Melancholic features may not be a valid predictor of more favorable response to antidepressant combination therapy as initial treatment.
KW - Bupropion
KW - Escitalopram
KW - Major depressive disorder
KW - Melancholic features
KW - Mirtazapine
KW - Venlafaxine
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U2 - 10.1016/j.jad.2011.04.032
DO - 10.1016/j.jad.2011.04.032
M3 - Article
C2 - 21601287
AN - SCOPUS:80052080314
VL - 133
SP - 467
EP - 476
JO - Journal of Affective Disorders
JF - Journal of Affective Disorders
SN - 0165-0327
IS - 3
ER -