The safety and tolerability of duloxetine in depressed elderly patients with and without medical comorbidity: Duloxetine in elderly patients with depression
Open accessAbstract
AIM AND METHODS: The impact of medical comorbidity on the efficacy and tolerability of duloxetine in elderly patients with major depressive disorder (MDD) was investigated in this study. Data were obtained from a multicentre, randomised, double-blind, placebo-controlled study in 311 patients with MDD aged 65-89. The primary outcome measure was a prespecified composite cognitive score based on four cognitive tests: (i) Verbal Learning and Recall Test; (ii) Symbol Digit Substitution Test; (iii) 2-Digit Cancellation Test and (iv) Letter-Number Sequencing Test. Secondary measures included the Geriatric Depression Scale (GDS), 17-Item Hamilton Depression Scale (HAMD17), Clinical Global Impression-Severity (CGI-S) Scale, Visual Analogue Scale (VAS) for pain and 36-Item Short Form Health Survey (SF-36). Tolerability measures included adverse events reported as the reason for discontinuation and treatment-emergent adverse events (TEAEs). The consistency of the effect of duloxetine vs. placebo comparing patients with and without medical comorbidity (vascular disease, diabetes, arthritis or any of these) was investigated. RESULTS: Overall, duloxetine 60 mg/day demonstrated significantly greater improvement compared with placebo for the composite cognitive score, GDS and HAMD17 total scores, CGI-Severity, HAMD17 response and remission rates, and some of the SF-36 and VAS measures. There were few significant treatment-by-comorbidity subgroup interactions for these efficacy variables, or for adverse events reported as the reason for discontinuation and common TEAEs. CONCLUSIONS: The present analyses suggested that the efficacy of duloxetine on cognition and depression in elderly patients, and its tolerability, were not largely affected by the comorbidity status. These results further support the use of duloxetine in elderly patients with MDD.
The claims and statistics of this paper haven’t been checked yet.
Run the check — free, no account needed. It reads the open-access text and checks the sources it cites.
Integrity signals
Registry
Cites
Statistics
Claims the paper makes
The claims and statistics of this paper haven’t been checked yet.
Run the check — free, no account needed. It reads the open-access text and checks the sources it cites.
Claims other papers make about this one
Each is checked against this paper’s own text: does it say what the citing paper says it does?
Except for the report by Wise et al, the potential impact of comorbid medical conditions on cognitive function was generally not addressed.
“except for the report by Wise et al,30 the potential impact of comorbid medical conditions on cognitive function were generally not addressed.”
From Cognitive Effects of Pharmacotherapy for Major Depressive Disorder: A Systematic Review (2014) · cites this paper as [30]
Six reports stated or described analyses indicating that corrections for multiple comparisons were not made.
“6 reports24,25,30,31,41,55 stated or described the analyses in such a manner as to indicate that corrections were not made.”
From Cognitive Effects of Pharmacotherapy for Major Depressive Disorder: A Systematic Review (2014) · cites this paper as [30]
Self-check
Percentages, sums and reported differences re-computed from the paper’s own numbers.
The self-check needs the paper’s full text.
Cites
Kok, J. S., Berg, I. J., & Scherder, E. J. A. (2013) · Dementia and Geriatric Cognitive Disorders Extra · doi:10.1159/000353441 · Cited by 20,589 · see citing works
Depression and Diabetes: Impact of Depressive Symptoms on Adherence, Function, and Costs
Ciechanowski, P. S., Katon, W. J., & Russo, J. E. (2000) · Archives of Internal Medicine · doi:10.1001/archinte.160.21.3278 · Cited by 1,465 · see citing works
(1996) · American Journal of Psychiatry · doi:10.1176/ajp.153.8.1001 · Cited by 725 · see citing works
Unützer, J. (1997) · JAMA · doi:10.1001/jama.1997.03540440052032 · Cited by 697 · see citing works
Impact of major depression on chronic medical illness
Katon, W., & Ciechanowski, P. (2002) · Journal of Psychosomatic Research · doi:10.1016/s0022-3999(02)00313-6 · Cited by 485 · see citing works
Raskin, J., Wiltse, C. G., Siegal, A., Sheikh, J., Xu, J., Dinkel, J. J., Rotz, B. T., & Mohs, R. C. (2007) · American Journal of Psychiatry · doi:10.1176/ajp.2007.164.6.900 · Cited by 329 · see citing works
Self-citation
Flagged first, then by citations
Research works printed but not linked: 43
- [1]NIH consensus conference Diagnosis and treatment of depression in late life JAMA 1992 268 1018 24 1501308
- [2]Steffens DC Skoog I Norton MC Prevalence of depression and its treatment in an elderly population: the Cache County study Arch Gen Psychiatry 2000 57 601 7 10839339
- [4]Palsson S Skoog I The epidemiology of affective disorders in the elderly: a review Int Clin Psychopharmacol 1997 12 Suppl. 7 S3 13 9476134
- [6]Ziegelstein RC Depression in patients recovering from a myocardial infarction JAMA 2001 286 1621 7 11585486
- [7]Anderson RJ Freedland KE Clouse RE Lustman PJ The prevalence of comorbid depression in adults with diabetes: a meta-analysis Diabetes Care 2001 24 1069 78 11375373
- [8]Dickens C McGowan L Clark-Carter D Creed F Depression in rheumatoid arthritis: a systematic review of the literature with meta-analysis Psychosom Med 2002 64 52 60 11818586
- [9]Frasure-Smith N Lesperance F Talajic M Depression following myocardial infarction. Impact on 6-month survival JAMA 1993 270 1819 25 8411525
- [10]Frasure-Smith N Lesperance F Talajic M Depression and 18-month prognosis after myocardial infarction Circulation 1995 91 999 1005 7531624
- [11]Ickovics JR Hamburger ME Vlahov D Mortality, CD4 cell count decline, and depressive symptoms among HIV-seropositive women: longitudinal analysis from the HIV Epidemiology Research Study JAMA 2001 285 1466 74 11255423
- [12]Wassertheil-Smoller S Applegate WB Berge K Change in depression as a precursor of cardiovascular events. SHEP Cooperative Research Group (Systoloc Hypertension in the elderly) Arch Intern Med 1996 156 553 61 8604962
- [15]Bymaster FP Dreshfield-Ahmad LJ Threlkeld PG Comparative affinity of duloxetine and venlafaxine for serotonin and norepinephrine transporters in vitro and in vivo, human serotonin receptor subtypes, and other neuronal receptors Neuropsychopharmacology 2001 25 871 80 11750180
- [16]Ressler KJ Nemeroff CB Role of norepinephrine in the pathophysiology of neuropsychiatric disorders CNS Spectr 2001 6 670 15520614
- [17]Reneman L Lavalaye J Schmand B Cortical serotonin transporter density and verbal memory in individuals who stopped using 3,4-methylenedioxymethamphetamine (MDMA or ‘ecstasy’): preliminary findings Arch Gen Psychiatry 2001 58 901 6 11576026
- [18]Nelson JC Wohlreich MM Mallinckrodt CH Detke MJ Watkin JG Kennedy JS Duloxetine for the treatment of major depressive disorder in older patients Am J Geriatr Psychiatry 2005 13 227 35 15728754
- [21]Sheehan DV Lecrubier Y Sheehan KH The Mini-International Neuropsychiatric Interview (M.I.N.I.): the development and validation of a structured diagnostic psychiatric interview for DSM-IV and ICD-10 J Clin Psychiatry 1998 59 Suppl. 20 22 33 9881538
- [22]Hamilton M A rating scale for depression J Neurol Neurosurg Psychiatry 1960 23 56 62 14399272 PMC495331
- [23]Folstein MF Folstein SE McHugh PR ‘Mini-mental state’. A practical method for grading the cognitive state of patients for the clinician J Psychiatr Res 1975 12 189 98 1202204
- [25]Lezak M Neuropsychological Assessment 1995 New York Oxford 438 45
- [27]Burt DB Zembar MJ Niederehe G Depression and memory impairment: a meta-analysis of the association, its pattern, and specificity Psychol Bull 1995 117 285 305 7724692
- [28]Cohen RM Weingartner H Smallberg SA Pickar D Murphy DL Effort and cognition in depression Arch Gen Psychiatry 1982 39 593 7 7092490
- [29]Yesavage JA Brink TL Rose TL Development and validation of a geriatric depression screening scale: a preliminary report J Psychiatr Res 1982 17 37 49 7183759
- [30]Sheikh JI Yesavage JA Geriatric Depression Scale (GDS): Recent evidence and development of a shorter version. Clinical Gerontology: A Guide to Assessment and Intervention 1986 New York The Haworth Press 165 73
- [31]DeLoach LJ Higgins MS Caplan AB Stiff JL The visual analog scale in the immediate postoperative period: intrasubject variability and correlation with a numeric scale Anesth Analg 1998 86 102 6 9428860
- [32]Butters MA Becker JT Nebes RD Changes in cognitive functioning following treatment of late-life depression Am J Psychiatry 2000 157 1949 54 11097959
- [33]Nebes RD Pollock BG Houck PR Persistence of cognitive impairment in geriatric patients following antidepressant treatment: a randomized, double-blind clinical trial with nortriptyline and paroxetine J Psychiatr Res 2003 37 99 108 12842163
- [34]O'Brien J Ames D Chiu E Schweitzer I Desmond P Tress B Severe deep white matter lesions and outcome in elderly patients with major depressive disorder: follow up study BMJ 1998 317 982 4 9765166 PMC28682
- [35]Sternberg DE Jarvik ME Memory functions in depression Arch Gen Psychiatry 1976 33 219 24 1252098
- [36]Andersson HI Ejlertsson G Leden I Rosenberg C Chronic pain in a geographically defined general population: studies of differences in age, gender, social class, and pain localization Clin J Pain 1993 9 174 82 8219517
- [37]Turk DC Okifuji A Scharff L Chronic pain and depression: role of perceived impact and perceived control in different age cohorts Pain 1995 61 93 101 7644253
- [38]Raskin J Pritchett YL Wang F A double-blind, randomized multicenter trial comparing duloxetine with placebo in the management of diabetic peripheral neuropathic pain Pain Med 2005 6 346 56 16266355
- [39]Wernicke JF Pritchett YL D'Souza DN A randomized controlled trial of duloxetine in diabetic peripheral neuropathic pain Neurology 2006 24 1411 20 17060567
- [40]Brannan SK Mallinckrodt CH Brown EB Wohlreich MM Watkin JG Schatzberg AF Duloxetine 60 mg once-daily in the treatment of painful physical symptoms in patients with major depressive disorder J Psychiatr Res 2005 39 43 53 15504423
- [41]Sheikh JI Cassidy EL Doraiswamy PM Efficacy, safety, and tolerability of sertraline in patients with late-life depression and comorbid medical illness J Am Geriatr Soc 2004 52 86 92 14687320
- [42]Gill D Hatcher S A systematic review of the treatment of depression with antidepressant drugs in patients who also have a physical illness J Psychosom Res 1999 47 131 43 10579497
- [43]Evans M Hammond M Wilson K Lye M Copeland J Treatment of depression in the elderly: effect of physical illness on response Int J Geriatr Psychiatry 1997 12 1189 94 9444543
- [44]Krishnan KR Doraiswamy PM Clary CM Clinical and treatment response characteristics of late-life depression associated with vascular disease: a pooled analysis of two multicenter trials with sertraline Prog Neuropsychopharmacol Biol Psychiatry 2001 25 347 61 11294481
- [45]Small GW Birkett M Meyers BS Koran LM Bystritsky A Nemeroff CB Impact of physical illness on quality of life and antidepressant response in geriatric major depression. Fluoxetine Collaborative Study Group J Am Geriatr Soc 1996 44 1220 5 8856002
- [46]Walsh BT Sysko R Placebo control groups in trials of major depressive disorder among older patients J Clin Psychopharmacol 2005 25 4 Suppl. 1 S29 33 16027558
- [47]Schatzberg A Roose S A double-blind, placebo-controlled study of venlafaxine and fluoxetine in geriatric outpatients with major depression Am J Geriatr Psychiatry 2006 14 361 70 16582045
- [48]Roose SP Sackeim HA Krishnan KR Antidepressant pharmacotherapy in the treatment of depression in the very old: a randomized, placebo-controlled trial Am J Psychiatry 2004 161 2050 9 15514406
- [49]Tollefson GD Bosomworth JC Heiligenstein JH Potvin JH Holman S A double-blind, placebo-controlled clinical trial of fluoxetine in geriatric patients with major depression. The Fluoxetine Collaborative Study Group Int Psychogeriatr 1995 7 89 104 7579025
- [50]Goldstein DJ Lu Y Detke MJ Hudson JI Demitrack MA Effects of duloxetine on painful physical symptoms associated with depression Psychosomatics 2004 45 17 28 14709757
- [51]Roose SP Sackeim HA Clinical trials in late-life depression: revisited Am J Geriatr Psychiatry 2002 10 503 5 12213683
Cited by
Sorted by citations
Cognitive Effects of Pharmacotherapy for Major Depressive Disorder: A Systematic Review
Keefe, R. S. E., McClintock, S. M., Roth, R. M., Doraiswamy, P. M., Tiger, S., & Madhoo, M. (2014) · The Journal of Clinical Psychiatry · doi:10.4088/jcp.13r08609 · Cited by 107 · see citing works
Tham, A., Jonsson, U., Andersson, G., Söderlund, A., Allard, P., & Bertilsson, G. (2016) · Journal of Affective Disorders · doi:10.1016/j.jad.2016.06.013 · Cited by 104 · see citing works
Baba, H., Kito, S., Nukariya, K., Takeshima, M., Fujise, N., Iga, J., Oshibuchi, H., Kawano, M., Kimura, M., Mizukami, K., et al. (2022) · Psychiatry and Clinical Neurosciences · doi:10.1111/pcn.13349 · Cited by 50 · see citing works
Adverse reactions to duloxetine in depression
Bitter, I., Filipovits, D., & Czobor, P. (2011) · Expert Opinion on Drug Safety · doi:10.1517/14740338.2011.582037 · Cited by 38 · see citing works
Florea, I., Danchenko, N., Brignone, M., Loft, H., Rive, B., & Abetz-Webb, L. (2015) · Clinical Therapeutics · doi:10.1016/j.clinthera.2015.08.008 · Cited by 35 · see citing works
Dodd, S., Berk, M., Kelin, K., Mancini, M., & Schacht, A. (2013) · Journal of Affective Disorders · doi:10.1016/j.jad.2013.04.016 · Cited by 20 · see citing works
Reddy, S., Fayyad, R., Edgar, C. J., Guico-Pabia, C. J., & Wesnes, K. (2016) · Journal of Psychopharmacology · doi:10.1177/0269881116631649 · Cited by 17 · see citing works
- Authors
- Wise, T. N., Wiltse, C. G., Iosifescu, D. V., Sheridan, M., Xu, J. Y., & Raskin, J.
- Affiliations
- Inova Fairfax Hospital (US)
- Eli Lilly (United States) (US)
- Massachusetts General Hospital (US)
- Eli Lilly (Canada) (CA)
- Corresponding author
- Raskin, J.
- Venue
- International Journal of Clinical Practice
- Publisher
- Hindawi Limited
- Published
- 2007-06-22
- Volume
- 61
- Issue
- 8
- Pages
- 1283-1293
- ISSN
- 1368-5031 (ISSN-L)
- PMC
- PMC2408656
- OpenAlex
- W1846868862
- Cited by
- 62
- References
- 6
- Citations by year
- 2025: 2 · 2023: 1 · 2022: 1 · 2021: 2 · 2020: 2 · 2019: 2 · 2017: 5 · 2016: 5 · 2015: 2 · 2014: 7 · 2013: 4 · 2012: 4
- FWCI
- 3.79
- Type
- journal article
- Language
- en
- Open access
- bronze
- doi.org
- Locations
- International Journal of Clinical Practice (publishedVersion)
- Europe PMC (PubMed Central) (publishedVersion)
- PubMed Central (publishedVersion)
- PubMed (publishedVersion)
- Funders
- Eli Lilly and Company
- Topics
- Health Sciences › Medicine › Pharmacology › Treatment of Major Depression
- Social Sciences › Psychology › Experimental and Cognitive Psychology › Anxiety, Depression, Psychometrics, Treatment, Cognitive Processes
- Social Sciences › Psychology › Social Psychology › Mental Health Treatment and Access
- Keywords
- duloxetine, major depressive disorder, elderly patients, comorbidities, antidepressant efficacy, tolerability, cognitive function, treatment-emergent adverse events, vascular disease, diabetes mellitus, arthritis, depression remission
- MeSH terms
- Duloxetine Hydrochloride, Aged, Aged, 80 and over, Antidepressive Agents, Arthritis, Cardiovascular Diseases, Depressive Disorder, Major, Major Depressive Disorder, Double-Blind Method, Female, Humans, Male, Pain, Pain Measurement, Severity of Illness Index, Thiophenes, Treatment Outcome
About these checks
Registry, retraction, Cites and statistics results are computed, not judged, with one exception: a printed reference that no index lists is read once by a model before it counts as a citation error. Claims are extracted by a model and kept only when their quote appears verbatim in the text; each cited source is then checked, with a model’s help, for whether it says what the claim relies on. Those verdicts can be wrong — read the claim’s quote and the cited source before relying on one.
Statistics and arithmetic are recomputed, not judged.
Confidence bands are shown only for fields calibrated on our annotated test set. None is calibrated yet, so no band is shown.
What counts as a claim ›How we measure confidence ›How we check this ›
Are you an author, or do you see a problem with this page? Request a review