Skip to main content
Top
Published in: Trials 1/2009

Open Access 01-12-2009 | Study protocol

Rationale, design and methodology of a double-blind, randomized, placebo-controlled study of escitalopram in prevention of Depression in Acute Coronary Syndrome (DECARD)

Authors: Baiba Hedegaard Hansen, Jamal Abed Hanash, Alice Rasmussen, Jørgen Fischer Hansen, Morten Birket-Smith

Published in: Trials | Issue 1/2009

Login to get access

Abstract

Background

The prevalence of depression in patients with acute coronary syndrome, i.e. myocardial infarction and unstable angina, is higher than in the general population. The prevalence of anxiety is higher as well. Both depression and anxiety are associated with poor cardiac outcomes and higher mortality. Comorbid depression in patients with acute coronary syndrome often goes undiagnosed, and it is therefore a challenging task to prevent this risk factor. The study of DEpression in Coronary ARtery Disease (DECARD) is designed to examine if it is possible to prevent depression in patients with acute coronary syndrome.

Methods

Two hundred forty non-depressed patients with acute coronary syndrome are randomized to treatment with either escitalopram or placebo for 1 year. Psychiatric and cardiac assessment of patients is performed to evaluate the possibility of preventing depression. Diagnosis of depression and Hamilton Depression Scale are the primary outcome measures.

Discussion

This is the first study of prevention of depression in patients after acute coronary syndrome with a selective serotonin reuptake inhibitor.

Trial Registration

Appendix
Available only for authorised users
Literature
1.
go back to reference Sorensen C, Brandes A, Hendricks O, Thrane J, Friis-Hasche E, Haghfelt T, Bech P: Psychosocial predictors of depression in patients with acute coronary syndrome. Acta Psychiatr Scand. 2005, 111: 116-124. 10.1111/j.1600-0447.2004.00430.x.CrossRefPubMed Sorensen C, Brandes A, Hendricks O, Thrane J, Friis-Hasche E, Haghfelt T, Bech P: Psychosocial predictors of depression in patients with acute coronary syndrome. Acta Psychiatr Scand. 2005, 111: 116-124. 10.1111/j.1600-0447.2004.00430.x.CrossRefPubMed
2.
go back to reference Ellis JJ, Eagle KA, Kline-Rogers EM, Erickson SR: Depressive symptoms and treatment after acute coronary syndrome. Int J Cardiol. 2005, 99: 443-447. 10.1016/j.ijcard.2004.09.011.CrossRefPubMed Ellis JJ, Eagle KA, Kline-Rogers EM, Erickson SR: Depressive symptoms and treatment after acute coronary syndrome. Int J Cardiol. 2005, 99: 443-447. 10.1016/j.ijcard.2004.09.011.CrossRefPubMed
3.
go back to reference Spijkerman T, de Jonge P, Brink van den RH, Jansen JH, May JF, Crijns HJ, Ormel J: Depression following myocardial infarction: first-ever versus ongoing and recurrent episodes. Gen Hosp Psychiatry. 2005, 27: 411-417. 10.1016/j.genhosppsych.2005.05.007.CrossRefPubMed Spijkerman T, de Jonge P, Brink van den RH, Jansen JH, May JF, Crijns HJ, Ormel J: Depression following myocardial infarction: first-ever versus ongoing and recurrent episodes. Gen Hosp Psychiatry. 2005, 27: 411-417. 10.1016/j.genhosppsych.2005.05.007.CrossRefPubMed
4.
go back to reference Mallik S, Spertus JA, Reid KJ, Krumholz HM, Rumsfeld JS, Weintraub WS, Agarwal P, Santra M, Bidyasar S, Lichtman JH, Wenger NK, Vaccarino V, PREMIER Registry Investigators: Depressive symptoms after acute myocardial infarction: evidence for highest rates in younger women. Arch Intern Med. 2006, 166: 876-883. 10.1001/archinte.166.8.876.CrossRefPubMed Mallik S, Spertus JA, Reid KJ, Krumholz HM, Rumsfeld JS, Weintraub WS, Agarwal P, Santra M, Bidyasar S, Lichtman JH, Wenger NK, Vaccarino V, PREMIER Registry Investigators: Depressive symptoms after acute myocardial infarction: evidence for highest rates in younger women. Arch Intern Med. 2006, 166: 876-883. 10.1001/archinte.166.8.876.CrossRefPubMed
5.
go back to reference McGee HM, Doyle F, Conroy RM, De La HD, Shelley E: Impact of briefly-assessed depression on secondary prevention outcomes after acute coronary syndrome: a one-year longitudinal survey. BMC Health Serv Res. 2006, 6: 9-10.1186/1472-6963-6-9.CrossRefPubMedPubMedCentral McGee HM, Doyle F, Conroy RM, De La HD, Shelley E: Impact of briefly-assessed depression on secondary prevention outcomes after acute coronary syndrome: a one-year longitudinal survey. BMC Health Serv Res. 2006, 6: 9-10.1186/1472-6963-6-9.CrossRefPubMedPubMedCentral
6.
go back to reference Frasure-Smith N, Lesperance F, Talajic M: Depression and 18-month prognosis after myocardial infarction. Circulation. 1995, 91: 999-1005.CrossRefPubMed Frasure-Smith N, Lesperance F, Talajic M: Depression and 18-month prognosis after myocardial infarction. Circulation. 1995, 91: 999-1005.CrossRefPubMed
7.
go back to reference Frasure-Smith N, Lesperance F, Gravel G, Masson A, Juneau M, Talajic M, Bourassa MG: Depression and health-care costs during the first year following myocardial infarction. J Psychosom Res. 2000, 48: 471-478. 10.1016/S0022-3999(99)00088-4.CrossRefPubMed Frasure-Smith N, Lesperance F, Gravel G, Masson A, Juneau M, Talajic M, Bourassa MG: Depression and health-care costs during the first year following myocardial infarction. J Psychosom Res. 2000, 48: 471-478. 10.1016/S0022-3999(99)00088-4.CrossRefPubMed
8.
go back to reference Grace SL, Abbey SE, Kapral MK, Fang J, Nolan RP, Stewart DE: Effect of depression on five-year mortality after an acute coronary syndrome. Am J Cardiol. 2005, 96: 1179-1185. 10.1016/j.amjcard.2005.06.052.CrossRefPubMed Grace SL, Abbey SE, Kapral MK, Fang J, Nolan RP, Stewart DE: Effect of depression on five-year mortality after an acute coronary syndrome. Am J Cardiol. 2005, 96: 1179-1185. 10.1016/j.amjcard.2005.06.052.CrossRefPubMed
9.
go back to reference Denollet J, Strik JJ, Lousberg R, Honig A: Recognizing increased risk of depressive comorbidity after myocardial infarction: looking for 4 symptoms of anxiety-depression. Psychother Psychosom. 2006, 75: 346-352. 10.1159/000095440.CrossRefPubMed Denollet J, Strik JJ, Lousberg R, Honig A: Recognizing increased risk of depressive comorbidity after myocardial infarction: looking for 4 symptoms of anxiety-depression. Psychother Psychosom. 2006, 75: 346-352. 10.1159/000095440.CrossRefPubMed
10.
go back to reference Pedersen SS, Denollet J, Spindler H, Ong AT, Serruys PW, Erdman RA, van Domburg RT: Anxiety enhances the detrimental effect of depressive symptoms on health status following percutaneous coronary intervention. J Psychosom Res. 2006, 61: 783-789. 10.1016/j.jpsychores.2006.06.009.CrossRefPubMed Pedersen SS, Denollet J, Spindler H, Ong AT, Serruys PW, Erdman RA, van Domburg RT: Anxiety enhances the detrimental effect of depressive symptoms on health status following percutaneous coronary intervention. J Psychosom Res. 2006, 61: 783-789. 10.1016/j.jpsychores.2006.06.009.CrossRefPubMed
11.
go back to reference Strik JJ, Denollet J, Lousberg R, Honig A: Comparing symptoms of depression and anxiety as predictors of cardiac events and increased health care consumption after myocardial infarction. J Am Coll Cardiol. 2003, 42: 1801-1807. 10.1016/j.jacc.2003.07.007.CrossRefPubMed Strik JJ, Denollet J, Lousberg R, Honig A: Comparing symptoms of depression and anxiety as predictors of cardiac events and increased health care consumption after myocardial infarction. J Am Coll Cardiol. 2003, 42: 1801-1807. 10.1016/j.jacc.2003.07.007.CrossRefPubMed
12.
go back to reference Frasure-Smith N, Lesperance F, Talajic M: The impact of negative emotions on prognosis following myocardial infarction: is it more than depression?. Health Psychol. 1995, 14: 388-398. 10.1037/0278-6133.14.5.388.CrossRefPubMed Frasure-Smith N, Lesperance F, Talajic M: The impact of negative emotions on prognosis following myocardial infarction: is it more than depression?. Health Psychol. 1995, 14: 388-398. 10.1037/0278-6133.14.5.388.CrossRefPubMed
13.
go back to reference Fauerbach JA, Bush DE, Thombs BD, McCann UD, Fogel J, Ziegelstein RC: Depression following acute myocardial infarction: a prospective relationship with ongoing health and function. Psychosomatics. 2005, 46: 355-361. 10.1176/appi.psy.46.4.355.CrossRefPubMed Fauerbach JA, Bush DE, Thombs BD, McCann UD, Fogel J, Ziegelstein RC: Depression following acute myocardial infarction: a prospective relationship with ongoing health and function. Psychosomatics. 2005, 46: 355-361. 10.1176/appi.psy.46.4.355.CrossRefPubMed
14.
go back to reference van Melle JP, de Jonge P, Ormel J, Crijns HJ, van Veldhuisen DJ, Honig A, Schene AH, Berg van den MP, MIND-IT investigators: Relationship between left ventricular dysfunction and depression following myocardial infarction: data from the MIND-IT. Eur Heart J. 2005, 26: 2650-2656. 10.1093/eurheartj/ehi480.CrossRefPubMed van Melle JP, de Jonge P, Ormel J, Crijns HJ, van Veldhuisen DJ, Honig A, Schene AH, Berg van den MP, MIND-IT investigators: Relationship between left ventricular dysfunction and depression following myocardial infarction: data from the MIND-IT. Eur Heart J. 2005, 26: 2650-2656. 10.1093/eurheartj/ehi480.CrossRefPubMed
15.
go back to reference Berkman LF, Blumenthal J, Burg M, Carney RM, Catellier D, Cowan MJ, Czajkowski SM, DeBusk R, Hosking J, Jaffe A, Kaufmann PG, Mitchell P, Norman J, Powell LH, Raczynski JM, Schneiderman N, Enhancing Recovery in Coronary Heart Disease Patients Investigators (ENRICHD): Effects of treating depression and low perceived social support on clinical events after myocardial infarction: the Enhancing Recovery in Coronary Heart Disease Patients (ENRICHD) Randomized Trial. JAMA. 2003, 289: 3106-3116. 10.1001/jama.289.23.3106.CrossRefPubMed Berkman LF, Blumenthal J, Burg M, Carney RM, Catellier D, Cowan MJ, Czajkowski SM, DeBusk R, Hosking J, Jaffe A, Kaufmann PG, Mitchell P, Norman J, Powell LH, Raczynski JM, Schneiderman N, Enhancing Recovery in Coronary Heart Disease Patients Investigators (ENRICHD): Effects of treating depression and low perceived social support on clinical events after myocardial infarction: the Enhancing Recovery in Coronary Heart Disease Patients (ENRICHD) Randomized Trial. JAMA. 2003, 289: 3106-3116. 10.1001/jama.289.23.3106.CrossRefPubMed
16.
go back to reference Glassman AH, O'Connor CM, Califf RM, Swedberg K, Schwartz P, Bigger JT, Krishnan KR, van Zyl LT, Swenson JR, Finkel MS, Landau C, Shapiro PA, Pepine CJ, Mardekian J, Harrison WM, Barton D, Mclvor M, Sertraline Antidepressant Heart Attack Randomized Trial (SADHEART) Group: Sertraline treatment of major depression in patients with acute MI or unstable angina. JAMA. 2002, 288: 701-709. 10.1001/jama.288.6.701.CrossRefPubMed Glassman AH, O'Connor CM, Califf RM, Swedberg K, Schwartz P, Bigger JT, Krishnan KR, van Zyl LT, Swenson JR, Finkel MS, Landau C, Shapiro PA, Pepine CJ, Mardekian J, Harrison WM, Barton D, Mclvor M, Sertraline Antidepressant Heart Attack Randomized Trial (SADHEART) Group: Sertraline treatment of major depression in patients with acute MI or unstable angina. JAMA. 2002, 288: 701-709. 10.1001/jama.288.6.701.CrossRefPubMed
17.
go back to reference van Melle JP, de Jonge P, Honig A, Schene AH, Kuyper AM, Crijns HJ, Schins A, Tulner D, Berg van den MP, Ormel J, MIND-IT investigators: Effects of antidepressant treatment following myocardial infarction. Br J Psychiatry. 2007, 190: 460-466. 10.1192/bjp.bp.106.028647.CrossRefPubMed van Melle JP, de Jonge P, Honig A, Schene AH, Kuyper AM, Crijns HJ, Schins A, Tulner D, Berg van den MP, Ormel J, MIND-IT investigators: Effects of antidepressant treatment following myocardial infarction. Br J Psychiatry. 2007, 190: 460-466. 10.1192/bjp.bp.106.028647.CrossRefPubMed
18.
go back to reference Lesperance F, Frasure-Smith N, Koszycki D, Laliberte MA, Van Zyl LT, Baker B, Swenson JR, Ghatavi K, Abramson BL, Dorian P, Guertin MC, CREATE Investigators: Effects of citalopram and interpersonal psychotherapy on depression in patients with coronary artery disease: the Canadian Cardiac Randomized Evaluation of Antidepressant and Psychotherapy Efficacy (CREATE) trial. JAMA. 2007, 297: 367-379. 10.1001/jama.297.4.367.CrossRefPubMed Lesperance F, Frasure-Smith N, Koszycki D, Laliberte MA, Van Zyl LT, Baker B, Swenson JR, Ghatavi K, Abramson BL, Dorian P, Guertin MC, CREATE Investigators: Effects of citalopram and interpersonal psychotherapy on depression in patients with coronary artery disease: the Canadian Cardiac Randomized Evaluation of Antidepressant and Psychotherapy Efficacy (CREATE) trial. JAMA. 2007, 297: 367-379. 10.1001/jama.297.4.367.CrossRefPubMed
19.
go back to reference Thombs BD, de Jonge P, Coyne JC, Whooley MA, Frasure-Smith N, Mitchell AJ, Zuidersma M, Eze-Nliam C, Lima BB, Smith CG, Soderlund K, Ziegelstein RC: Depression screening and patient outcomes in cardiovascular care: a systematic review. JAMA. 2008, 300: 2161-2171. 10.1001/jama.2008.667.CrossRefPubMed Thombs BD, de Jonge P, Coyne JC, Whooley MA, Frasure-Smith N, Mitchell AJ, Zuidersma M, Eze-Nliam C, Lima BB, Smith CG, Soderlund K, Ziegelstein RC: Depression screening and patient outcomes in cardiovascular care: a systematic review. JAMA. 2008, 300: 2161-2171. 10.1001/jama.2008.667.CrossRefPubMed
20.
go back to reference Carney RM, Saunders RD, Freedland KE, Stein P, Rich MW, Jaffe AS: Association of depression with reduced heart rate variability in coronary artery disease. Am J Cardiol. 1995, 76: 562-564. 10.1016/S0002-9149(99)80155-6.CrossRefPubMed Carney RM, Saunders RD, Freedland KE, Stein P, Rich MW, Jaffe AS: Association of depression with reduced heart rate variability in coronary artery disease. Am J Cardiol. 1995, 76: 562-564. 10.1016/S0002-9149(99)80155-6.CrossRefPubMed
21.
go back to reference Carney RM, Freedland KE, Veith RC, Cryer PE, Skala JA, Lynch T, Jaffe AS: Major depression, heart rate, and plasma norepinephrine in patients with coronary heart disease. Biol Psychiatry. 1999, 45: 458-463. 10.1016/S0006-3223(98)00049-3.CrossRefPubMed Carney RM, Freedland KE, Veith RC, Cryer PE, Skala JA, Lynch T, Jaffe AS: Major depression, heart rate, and plasma norepinephrine in patients with coronary heart disease. Biol Psychiatry. 1999, 45: 458-463. 10.1016/S0006-3223(98)00049-3.CrossRefPubMed
22.
go back to reference Carney RM, Freedland KE, Stein PK, Skala JA, Hoffman P, Jaffe AS: Change in heart rate and heart rate variability during treatment for depression in patients with coronary heart disease. Psychosom Med. 2000, 62: 639-647.CrossRefPubMed Carney RM, Freedland KE, Stein PK, Skala JA, Hoffman P, Jaffe AS: Change in heart rate and heart rate variability during treatment for depression in patients with coronary heart disease. Psychosom Med. 2000, 62: 639-647.CrossRefPubMed
23.
go back to reference Carney RM, Blumenthal JA, Stein PK, Watkins L, Catellier D, Berkman LF, Czajkowski SM, O'Connor C, Stone PH, Freedland KE: Depression, heart rate variability, and acute myocardial infarction. Circulation. 2001, 104: 2024-2028. 10.1161/hc4201.097834.CrossRefPubMed Carney RM, Blumenthal JA, Stein PK, Watkins L, Catellier D, Berkman LF, Czajkowski SM, O'Connor C, Stone PH, Freedland KE: Depression, heart rate variability, and acute myocardial infarction. Circulation. 2001, 104: 2024-2028. 10.1161/hc4201.097834.CrossRefPubMed
24.
go back to reference Carney RM, Blumenthal JA, Freedland KE, Stein PK, Howells WB, Berkman LF, Watkins LL, Czajkowski SM, Hayano J, Domitrovich PP, Jaffe AS: Low heart rate variability and the effect of depression on post-myocardial infarction mortality. Arch Intern Med. 2005, 165: 1486-1491. 10.1001/archinte.165.13.1486.CrossRefPubMed Carney RM, Blumenthal JA, Freedland KE, Stein PK, Howells WB, Berkman LF, Watkins LL, Czajkowski SM, Hayano J, Domitrovich PP, Jaffe AS: Low heart rate variability and the effect of depression on post-myocardial infarction mortality. Arch Intern Med. 2005, 165: 1486-1491. 10.1001/archinte.165.13.1486.CrossRefPubMed
25.
go back to reference Davidson J, Watkins L, Owens M, Krulewicz S, Connor K, Carpenter D, Krishnan R, Nemeroff C: Effects of paroxetine and venlafaxine XR on heart rate variability in depression. J Clin Psychopharmacol. 2005, 25: 480-484. 10.1097/01.jcp.0000177547.28961.03.CrossRefPubMed Davidson J, Watkins L, Owens M, Krulewicz S, Connor K, Carpenter D, Krishnan R, Nemeroff C: Effects of paroxetine and venlafaxine XR on heart rate variability in depression. J Clin Psychopharmacol. 2005, 25: 480-484. 10.1097/01.jcp.0000177547.28961.03.CrossRefPubMed
26.
go back to reference Kuijpers PM, Hamulyak K, Strik JJ, Wellens HJ, Honig A: Beta-thromboglobulin and platelet factor 4 levels in post-myocardial infarction patients with major depression. Psychiatry Res. 2002, 109: 207-210. 10.1016/S0165-1781(02)00017-3.CrossRefPubMed Kuijpers PM, Hamulyak K, Strik JJ, Wellens HJ, Honig A: Beta-thromboglobulin and platelet factor 4 levels in post-myocardial infarction patients with major depression. Psychiatry Res. 2002, 109: 207-210. 10.1016/S0165-1781(02)00017-3.CrossRefPubMed
27.
go back to reference Laghrissi-Thode F, Wagner WR, Pollock BG, Johnson PC, Finkel MS: Elevated platelet factor 4 and beta-thromboglobulin plasma levels in depressed patients with ischemic heart disease. Biol Psychiatry. 1997, 42: 290-295. 10.1016/S0006-3223(96)00345-9.CrossRefPubMed Laghrissi-Thode F, Wagner WR, Pollock BG, Johnson PC, Finkel MS: Elevated platelet factor 4 and beta-thromboglobulin plasma levels in depressed patients with ischemic heart disease. Biol Psychiatry. 1997, 42: 290-295. 10.1016/S0006-3223(96)00345-9.CrossRefPubMed
28.
go back to reference Serebruany VL, O'Connor CM, Gurbel PA: Effect of selective serotonin reuptake inhibitors on platelets in patients with coronary artery disease. Am J Cardiol. 2001, 87: 1398-1400. 10.1016/S0002-9149(01)01562-4.CrossRefPubMed Serebruany VL, O'Connor CM, Gurbel PA: Effect of selective serotonin reuptake inhibitors on platelets in patients with coronary artery disease. Am J Cardiol. 2001, 87: 1398-1400. 10.1016/S0002-9149(01)01562-4.CrossRefPubMed
29.
go back to reference Serebruany VL, Gurbel PA, O'Connor CM: Platelet inhibition by sertraline and N-desmethylsertraline: a possible missing link between depression, coronary events, and mortality benefits of selective serotonin reuptake inhibitors. Pharmacol Res. 2001, 43: 453-462. 10.1006/phrs.2001.0817.CrossRefPubMed Serebruany VL, Gurbel PA, O'Connor CM: Platelet inhibition by sertraline and N-desmethylsertraline: a possible missing link between depression, coronary events, and mortality benefits of selective serotonin reuptake inhibitors. Pharmacol Res. 2001, 43: 453-462. 10.1006/phrs.2001.0817.CrossRefPubMed
30.
go back to reference Broadley AJ, Korszun A, Jones CJ, Frenneaux MP: Arterial endothelial function is impaired in treated depression. Heart. 2002, 88: 521-523. 10.1136/heart.88.5.521.CrossRefPubMedPubMedCentral Broadley AJ, Korszun A, Jones CJ, Frenneaux MP: Arterial endothelial function is impaired in treated depression. Heart. 2002, 88: 521-523. 10.1136/heart.88.5.521.CrossRefPubMedPubMedCentral
31.
go back to reference Sherwood A, Hinderliter AL, Watkins LL, Waugh RA, Blumenthal JA: Impaired endothelial function in coronary heart disease patients with depressive symptomatology. J Am Coll Cardiol. 2005, 46: 656-659. 10.1016/j.jacc.2005.05.041.CrossRefPubMed Sherwood A, Hinderliter AL, Watkins LL, Waugh RA, Blumenthal JA: Impaired endothelial function in coronary heart disease patients with depressive symptomatology. J Am Coll Cardiol. 2005, 46: 656-659. 10.1016/j.jacc.2005.05.041.CrossRefPubMed
32.
go back to reference Amin AA, Jones AM, Nugent K, Rumsfeld JS, Spertus JA: The prevalence of unrecognized depression in patients with acute coronary syndrome. Am Heart J. 2006, 152: 928-934. 10.1016/j.ahj.2006.05.006.CrossRefPubMed Amin AA, Jones AM, Nugent K, Rumsfeld JS, Spertus JA: The prevalence of unrecognized depression in patients with acute coronary syndrome. Am Heart J. 2006, 152: 928-934. 10.1016/j.ahj.2006.05.006.CrossRefPubMed
33.
go back to reference Alpert JS, Thygesen K, Antman E, Bassand JP: Myocardial infarction redefined – a consensus document of The Joint European Society of Cardiology/American College of Cardiology Committee for the redefinition of myocardial infarction. J Am Coll Cardiol. 2000, 36: 959-969. 10.1016/S0735-1097(00)00804-4.CrossRefPubMed Alpert JS, Thygesen K, Antman E, Bassand JP: Myocardial infarction redefined – a consensus document of The Joint European Society of Cardiology/American College of Cardiology Committee for the redefinition of myocardial infarction. J Am Coll Cardiol. 2000, 36: 959-969. 10.1016/S0735-1097(00)00804-4.CrossRefPubMed
34.
go back to reference Schedules for Clinical Assessment in Neuropsychiatry, Version 2.1. Århus. 2000 Schedules for Clinical Assessment in Neuropsychiatry, Version 2.1. Århus. 2000
35.
go back to reference Spitzer RL, Williams JB, Kroenke K, Linzer M, deGruy FV, Hahn SR, Brody D, Johnson JG: Utility of a new procedure for diagnosing mental disorders in primary care. The PRIME-MD 1000 study. JAMA. 1994, 272: 1749-1756. 10.1001/jama.272.22.1749.CrossRefPubMed Spitzer RL, Williams JB, Kroenke K, Linzer M, deGruy FV, Hahn SR, Brody D, Johnson JG: Utility of a new procedure for diagnosing mental disorders in primary care. The PRIME-MD 1000 study. JAMA. 1994, 272: 1749-1756. 10.1001/jama.272.22.1749.CrossRefPubMed
37.
38.
go back to reference Guy W: ECDEU Assessment Manual for Psychopharmacology: Publication ADM 76-338. Washington, DC, US Department of Health, Education and Welfare. 1976, 218-222. Guy W: ECDEU Assessment Manual for Psychopharmacology: Publication ADM 76-338. Washington, DC, US Department of Health, Education and Welfare. 1976, 218-222.
39.
go back to reference Lingjaerde O, Ahlfors UG, Bech P, Dencker SJ, Elgen K: The UKU side effect rating scale. A new comprehensive rating scale for psychotropic drugs and a cross-sectional study of side effects in neuroleptic-treated patients. Acta Psychiatr Scand Suppl. 1987, 334: 1-100. 10.1111/j.1600-0447.1987.tb10566.x.CrossRefPubMed Lingjaerde O, Ahlfors UG, Bech P, Dencker SJ, Elgen K: The UKU side effect rating scale. A new comprehensive rating scale for psychotropic drugs and a cross-sectional study of side effects in neuroleptic-treated patients. Acta Psychiatr Scand Suppl. 1987, 334: 1-100. 10.1111/j.1600-0447.1987.tb10566.x.CrossRefPubMed
40.
go back to reference Beck AT, Ward CH, Mendelson M, Mock J, Erbaugh J: An inventory for measuring depression. Arch Gen Psychiatry. 1961, 4: 561-571.CrossRefPubMed Beck AT, Ward CH, Mendelson M, Mock J, Erbaugh J: An inventory for measuring depression. Arch Gen Psychiatry. 1961, 4: 561-571.CrossRefPubMed
41.
go back to reference Olsen LR, Mortensen EL, Bech P: The SCL-90 and SCL-90R versions validated by item response models in a Danish community sample. Acta Psychiatr Scand. 2004, 110: 225-229. 10.1111/j.1600-0447.2004.00399.x.CrossRefPubMed Olsen LR, Mortensen EL, Bech P: The SCL-90 and SCL-90R versions validated by item response models in a Danish community sample. Acta Psychiatr Scand. 2004, 110: 225-229. 10.1111/j.1600-0447.2004.00399.x.CrossRefPubMed
42.
go back to reference Ware JE, Sherbourne CD: The MOS 36-item short-form health survey (SF-36). I. Conceptual framework and item selection. Med Care. 1992, 30: 473-483. 10.1097/00005650-199206000-00002.CrossRefPubMed Ware JE, Sherbourne CD: The MOS 36-item short-form health survey (SF-36). I. Conceptual framework and item selection. Med Care. 1992, 30: 473-483. 10.1097/00005650-199206000-00002.CrossRefPubMed
43.
go back to reference Enhancing recovery in coronary heart disease patients (ENRICHD): study design and methods. The ENRICHD investigators. Am Heart J. 2000, 139: 1-9. Enhancing recovery in coronary heart disease patients (ENRICHD): study design and methods. The ENRICHD investigators. Am Heart J. 2000, 139: 1-9.
44.
go back to reference Murdoch D, Keam SJ: Escitalopram: a review of its use in the management of major depressive disorder. Drugs. 2005, 65: 2379-2404. 10.2165/00003495-200565160-00013.CrossRefPubMed Murdoch D, Keam SJ: Escitalopram: a review of its use in the management of major depressive disorder. Drugs. 2005, 65: 2379-2404. 10.2165/00003495-200565160-00013.CrossRefPubMed
45.
go back to reference Bech P O: Scales of Assessment of Diagnosis and Severity of Mental Disorders. Acta Psychiatr Scand Suppl. 1993, 87 (s372): 3-83. 10.1111/j.1600-0447.1993.tb05583.x.CrossRef Bech P O: Scales of Assessment of Diagnosis and Severity of Mental Disorders. Acta Psychiatr Scand Suppl. 1993, 87 (s372): 3-83. 10.1111/j.1600-0447.1993.tb05583.x.CrossRef
46.
go back to reference Lesperance F, Frasure-Smith N, Talajic M: Major depression before and after myocardial infarction: its nature and consequences. Psychosom Med. 1996, 58: 99-110.CrossRefPubMed Lesperance F, Frasure-Smith N, Talajic M: Major depression before and after myocardial infarction: its nature and consequences. Psychosom Med. 1996, 58: 99-110.CrossRefPubMed
47.
go back to reference Blier P, Keller MB, Pollack MH, Thase ME, Zajecka JM, Dunner DL: Preventing recurrent depression: long-term treatment for major depressive disorder. J Clin Psychiatry. 2007, 68: e06-CrossRefPubMed Blier P, Keller MB, Pollack MH, Thase ME, Zajecka JM, Dunner DL: Preventing recurrent depression: long-term treatment for major depressive disorder. J Clin Psychiatry. 2007, 68: e06-CrossRefPubMed
48.
go back to reference Lustman PJ, Clouse RE, Nix BD, Freedland KE, Rubin EH, McGill JB, Williams MM, Gelenberg AJ, Ciechanowski PS, Hirsch IB: Sertraline for prevention of depression recurrence in diabetes mellitus: a randomized, double-blind, placebo-controlled trial. Arch Gen Psychiatry. 2006, 63: 521-529. 10.1001/archpsyc.63.5.521.CrossRefPubMed Lustman PJ, Clouse RE, Nix BD, Freedland KE, Rubin EH, McGill JB, Williams MM, Gelenberg AJ, Ciechanowski PS, Hirsch IB: Sertraline for prevention of depression recurrence in diabetes mellitus: a randomized, double-blind, placebo-controlled trial. Arch Gen Psychiatry. 2006, 63: 521-529. 10.1001/archpsyc.63.5.521.CrossRefPubMed
49.
go back to reference Strik JJ, Honig A, Lousberg R, Lousberg AH, Cheriex EC, Tuynman-Qua HG, Kuijpers PM, Wellens HJ, Van Praag HM: Efficacy and safety of fluoxetine in the treatment of patients with major depression after first myocardial infarction: findings from a double-blind, placebo-controlled trial. Psychosom Med. 2000, 62: 783-789.CrossRefPubMed Strik JJ, Honig A, Lousberg R, Lousberg AH, Cheriex EC, Tuynman-Qua HG, Kuijpers PM, Wellens HJ, Van Praag HM: Efficacy and safety of fluoxetine in the treatment of patients with major depression after first myocardial infarction: findings from a double-blind, placebo-controlled trial. Psychosom Med. 2000, 62: 783-789.CrossRefPubMed
50.
go back to reference Rasmussen A, Lunde M, Poulsen DL, Sorensen K, Qvitzau S, Bech P: A double-blind, placebo-controlled study of sertraline in the prevention of depression in stroke patients. Psychosomatics. 2003, 44: 216-221. 10.1176/appi.psy.44.3.216.CrossRefPubMed Rasmussen A, Lunde M, Poulsen DL, Sorensen K, Qvitzau S, Bech P: A double-blind, placebo-controlled study of sertraline in the prevention of depression in stroke patients. Psychosomatics. 2003, 44: 216-221. 10.1176/appi.psy.44.3.216.CrossRefPubMed
51.
go back to reference Wade A, Despiegel N, Heldbo RE: Escitalopram in the long-term treatment of major depressive disorder. Ann Clin Psychiatry. 2006, 18: 83-89. 10.1080/10401230600614447.CrossRefPubMed Wade A, Despiegel N, Heldbo RE: Escitalopram in the long-term treatment of major depressive disorder. Ann Clin Psychiatry. 2006, 18: 83-89. 10.1080/10401230600614447.CrossRefPubMed
52.
go back to reference Swenson JR, Doucette S, Fergusson D: Adverse cardiovascular events in antidepressant trials involving high-risk patients: a systematic review of randomized trials. Can J Psychiatry. 2006, 51: 923-929.PubMed Swenson JR, Doucette S, Fergusson D: Adverse cardiovascular events in antidepressant trials involving high-risk patients: a systematic review of randomized trials. Can J Psychiatry. 2006, 51: 923-929.PubMed
53.
go back to reference Markovitz JH, Shuster JL, Chitwood WS, May RS, Tolbert LC: Platelet activation in depression and effects of sertraline treatment: An open-label study. Am J Psychiatry. 2000, 157: 1006-1008. 10.1176/appi.ajp.157.6.1006.CrossRefPubMed Markovitz JH, Shuster JL, Chitwood WS, May RS, Tolbert LC: Platelet activation in depression and effects of sertraline treatment: An open-label study. Am J Psychiatry. 2000, 157: 1006-1008. 10.1176/appi.ajp.157.6.1006.CrossRefPubMed
54.
go back to reference Javors MA, Houston JP, Tekell JL, Brannan SK, Frazer A: Reduction of platelet serotonin content in depressed patients treated with either paroxetine or desipramine. Int J Neuropsychopharmacol. 2000, 3: 229-235. 10.1017/S146114570000198X.CrossRefPubMed Javors MA, Houston JP, Tekell JL, Brannan SK, Frazer A: Reduction of platelet serotonin content in depressed patients treated with either paroxetine or desipramine. Int J Neuropsychopharmacol. 2000, 3: 229-235. 10.1017/S146114570000198X.CrossRefPubMed
55.
go back to reference Serebruany VL, Glassman AH, Malinin AI, Nemeroff CB, Musselman DL, Van Zyl LT, Finkel MS, Krishnan KR, Gaffney M, Harrison W, Califf RM, O'Connor CM, Sertraline AntiDepressant Heart Attack Randomized Trial Study Group: Platelet/endothelial biomarkers in depressed patients treated with the selective serotonin reuptake inhibitor sertraline after acute coronary events: the Sertraline AntiDepressant Heart Attack Randomized Trial (SADHART) Platelet Substudy. Circulation. 2003, 108: 939-944. 10.1161/01.CIR.0000085163.21752.0A.CrossRefPubMed Serebruany VL, Glassman AH, Malinin AI, Nemeroff CB, Musselman DL, Van Zyl LT, Finkel MS, Krishnan KR, Gaffney M, Harrison W, Califf RM, O'Connor CM, Sertraline AntiDepressant Heart Attack Randomized Trial Study Group: Platelet/endothelial biomarkers in depressed patients treated with the selective serotonin reuptake inhibitor sertraline after acute coronary events: the Sertraline AntiDepressant Heart Attack Randomized Trial (SADHART) Platelet Substudy. Circulation. 2003, 108: 939-944. 10.1161/01.CIR.0000085163.21752.0A.CrossRefPubMed
56.
go back to reference Maurer-Spurej E, Pittendreigh C, Solomons K: The influence of selective serotonin reuptake inhibitors on human platelet serotonin. Thromb Haemost. 2004, 91: 119-128.PubMed Maurer-Spurej E, Pittendreigh C, Solomons K: The influence of selective serotonin reuptake inhibitors on human platelet serotonin. Thromb Haemost. 2004, 91: 119-128.PubMed
57.
go back to reference Schlienger RG, Fischer LM, Jick H, Meier CR: Current use of selective serotonin reuptake inhibitors and risk of acute myocardial infarction. Drug Saf. 2004, 27: 1157-1165. 10.2165/00002018-200427140-00006.CrossRefPubMed Schlienger RG, Fischer LM, Jick H, Meier CR: Current use of selective serotonin reuptake inhibitors and risk of acute myocardial infarction. Drug Saf. 2004, 27: 1157-1165. 10.2165/00002018-200427140-00006.CrossRefPubMed
58.
go back to reference Sauer WH, Berlin JA, Kimmel SE: Effect of antidepressants and their relative affinity for the serotonin transporter on the risk of myocardial infarction. Circulation. 2003, 108: 32-36. 10.1161/01.CIR.0000079172.43229.CD.CrossRefPubMed Sauer WH, Berlin JA, Kimmel SE: Effect of antidepressants and their relative affinity for the serotonin transporter on the risk of myocardial infarction. Circulation. 2003, 108: 32-36. 10.1161/01.CIR.0000079172.43229.CD.CrossRefPubMed
59.
go back to reference Ziegelstein RC, Meuchel J, Kim TJ, Latif M, Alvarez W, Dasgupta N, Thombs BD: Selective serotonin reuptake inhibitor use by patients with acute coronary syndromes. Am J Med. 2007, 120: 525-530. 10.1016/j.amjmed.2006.10.026.CrossRefPubMed Ziegelstein RC, Meuchel J, Kim TJ, Latif M, Alvarez W, Dasgupta N, Thombs BD: Selective serotonin reuptake inhibitor use by patients with acute coronary syndromes. Am J Med. 2007, 120: 525-530. 10.1016/j.amjmed.2006.10.026.CrossRefPubMed
60.
go back to reference Belcher PR, Drake-Holland AJ, Noble MIM: Serotonin Reuptake Inhibitors and Cardiovascular Disease. Vascular Disease Prevention. 2005, 2: 67-76. 10.2174/1567270052774368.CrossRef Belcher PR, Drake-Holland AJ, Noble MIM: Serotonin Reuptake Inhibitors and Cardiovascular Disease. Vascular Disease Prevention. 2005, 2: 67-76. 10.2174/1567270052774368.CrossRef
61.
go back to reference Meijer WE, Heerdink ER, Nolen WA, Herings RM, Leufkens HG, Egberts AC: Association of risk of abnormal bleeding with degree of serotonin reuptake inhibition by antidepressants. Arch Intern Med. 2004, 164: 2367-2370. 10.1001/archinte.164.21.2367.CrossRefPubMed Meijer WE, Heerdink ER, Nolen WA, Herings RM, Leufkens HG, Egberts AC: Association of risk of abnormal bleeding with degree of serotonin reuptake inhibition by antidepressants. Arch Intern Med. 2004, 164: 2367-2370. 10.1001/archinte.164.21.2367.CrossRefPubMed
62.
go back to reference de Abajo FJ, Rodriguez LA, Montero D: Association between selective serotonin reuptake inhibitors and upper gastrointestinal bleeding: population based case-control study. BMJ. 1999, 319: 1106-1109.CrossRefPubMedPubMedCentral de Abajo FJ, Rodriguez LA, Montero D: Association between selective serotonin reuptake inhibitors and upper gastrointestinal bleeding: population based case-control study. BMJ. 1999, 319: 1106-1109.CrossRefPubMedPubMedCentral
63.
go back to reference Wessinger S, Kaplan M, Choi L, Williams M, Lau C, Sharp L, Crowell MD, Keshavarzian A, Jones MP: Increased use of selective serotonin reuptake inhibitors in patients admitted with gastrointestinal haemorrhage: a multicentre retrospective analysis. Aliment Pharmacol Ther. 2006, 23: 937-944. 10.1111/j.1365-2036.2006.02859.x.CrossRefPubMed Wessinger S, Kaplan M, Choi L, Williams M, Lau C, Sharp L, Crowell MD, Keshavarzian A, Jones MP: Increased use of selective serotonin reuptake inhibitors in patients admitted with gastrointestinal haemorrhage: a multicentre retrospective analysis. Aliment Pharmacol Ther. 2006, 23: 937-944. 10.1111/j.1365-2036.2006.02859.x.CrossRefPubMed
64.
go back to reference Dalton SO, Johansen C, Mellemkjaer L, Norgard B, Sorensen HT, Olsen JH: Use of selective serotonin reuptake inhibitors and risk of upper gastrointestinal tract bleeding: a population-based cohort study. Arch Intern Med. 2003, 163: 59-64. 10.1001/archinte.163.1.59.CrossRefPubMed Dalton SO, Johansen C, Mellemkjaer L, Norgard B, Sorensen HT, Olsen JH: Use of selective serotonin reuptake inhibitors and risk of upper gastrointestinal tract bleeding: a population-based cohort study. Arch Intern Med. 2003, 163: 59-64. 10.1001/archinte.163.1.59.CrossRefPubMed
65.
go back to reference Tata LJ, Fortun PJ, Hubbard RB, Smeeth L, Hawkey CJ, Smith CJ, Whitaker HJ, Farrington CP, Card TR, West J: Does concurrent prescription of selective serotonin reuptake inhibitors and non-steroidal anti-inflammatory drugs substantially increase the risk of upper gastrointestinal bleeding?. Aliment Pharmacol Ther. 2005, 22: 175-181. 10.1111/j.1365-2036.2005.02543.x.CrossRefPubMed Tata LJ, Fortun PJ, Hubbard RB, Smeeth L, Hawkey CJ, Smith CJ, Whitaker HJ, Farrington CP, Card TR, West J: Does concurrent prescription of selective serotonin reuptake inhibitors and non-steroidal anti-inflammatory drugs substantially increase the risk of upper gastrointestinal bleeding?. Aliment Pharmacol Ther. 2005, 22: 175-181. 10.1111/j.1365-2036.2005.02543.x.CrossRefPubMed
66.
go back to reference McFarlane A, Kamath MV, Fallen EL, Malcolm V, Cherian F, Norman G: Effect of sertraline on the recovery rate of cardiac autonomic function in depressed patients after acute myocardial infarction. Am Heart J. 2001, 142: 617-623. 10.1067/mhj.2001.116766.CrossRefPubMed McFarlane A, Kamath MV, Fallen EL, Malcolm V, Cherian F, Norman G: Effect of sertraline on the recovery rate of cardiac autonomic function in depressed patients after acute myocardial infarction. Am Heart J. 2001, 142: 617-623. 10.1067/mhj.2001.116766.CrossRefPubMed
67.
go back to reference Dickens CM, McGowan L, Percival C, Tomenson B, Cotter L, Heagerty A, Creed FH: Contribution of depression and anxiety to impaired health-related quality of life following first myocardial infarction. Br J Psychiatry. 2006, 189: 367-372. 10.1192/bjp.bp.105.018234.CrossRefPubMed Dickens CM, McGowan L, Percival C, Tomenson B, Cotter L, Heagerty A, Creed FH: Contribution of depression and anxiety to impaired health-related quality of life following first myocardial infarction. Br J Psychiatry. 2006, 189: 367-372. 10.1192/bjp.bp.105.018234.CrossRefPubMed
68.
go back to reference Konsensusrapport. Akut koronart syndrom. Retningslinjer for diagnostik og behandling. 2004, København, Dansk Cardiologisk Selskab Konsensusrapport. Akut koronart syndrom. Retningslinjer for diagnostik og behandling. 2004, København, Dansk Cardiologisk Selskab
Metadata
Title
Rationale, design and methodology of a double-blind, randomized, placebo-controlled study of escitalopram in prevention of Depression in Acute Coronary Syndrome (DECARD)
Authors
Baiba Hedegaard Hansen
Jamal Abed Hanash
Alice Rasmussen
Jørgen Fischer Hansen
Morten Birket-Smith
Publication date
01-12-2009
Publisher
BioMed Central
Published in
Trials / Issue 1/2009
Electronic ISSN: 1745-6215
DOI
https://doi.org/10.1186/1745-6215-10-20

Other articles of this Issue 1/2009

Trials 1/2009 Go to the issue