Relapse Prevention in Major Depressive Disorder After Successful Acute Electroconvulsive Treatment: a 6-month Double-blind Comparison of Three Fixed Dosages of Escitalopram and a Fixed Dose of Nortriptyline - Lessons from a Failed Randomised Trial of the Danish University Antidepressant Group (DUAG-7)

TY - JOUR

T1 - Relapse Prevention in Major Depressive Disorder After Successful Acute Electroconvulsive Treatment

T2 - a 6-month Double-blind Comparison of Three Fixed Dosages of Escitalopram and a Fixed Dose of Nortriptyline - Lessons from a Failed Randomised Trial of the Danish University Antidepressant Group (DUAG-7)

AU - Martiny, K

AU - Larsen, E R

AU - Licht, R W

AU - Nielsen, C T

AU - Damkier, P

AU - Refsgaard, E

AU - Lunde, M

AU - Straasø, B

AU - Christensen, E M

AU - Lolk, A

AU - Holmskov, J

AU - Sørensen, C H

AU - Brødsgaard, I

AU - Eftekhari, S Z

AU - Bendsen, B B

AU - Klysner, R

AU - Terp, I M

AU - Larsen, J K

AU - Vestergaard, P

AU - Buchholtz, P E

AU - Gram, L F

AU - Bech, P

AU - Danish University Antidepressant Group (DUAG)

N1 - © Georg Thieme Verlag KG Stuttgart · New York.

PY - 2015/11/3

Y1 - 2015/11/3

N2 - Introduction: Electroconvulsive treatment (ECT) is an effective treatment for severe depression but carries a risk of relapse in the following months. Methods: Major depressive disorder patients in a current episode attaining remission from ECT (17-item Hamilton Depression Rating Scale (HAM-D17) score≤9) received randomly escitalopram 10 mg, 20 mg, 30 mg or nortriptyline 100 mg as monotherapies and were followed for 6 months in a multicentre double-blind set-up. Primary endpoint was relapse (HAM-D17≥16). Results: As inclusion rate was low the study was prematurely stopped with only 47 patients randomised (20% of the planned sample size). No statistically significant between-group differences could be detected. When all patients receiving escitalopram were compared with those receiving nortriptyline, a marginal superiority of nortriptyline was found (p=0.08). One third of patients relapsed during the study period, and one third completed. Discussion: Due to small sample size, no valid efficacy inferences could be made. The outcome was poor, probably due to tapering off of non-study psychotropic drugs after randomisation; this has implications for future study designs. ClinicalTrials.gov

AB - Introduction: Electroconvulsive treatment (ECT) is an effective treatment for severe depression but carries a risk of relapse in the following months. Methods: Major depressive disorder patients in a current episode attaining remission from ECT (17-item Hamilton Depression Rating Scale (HAM-D17) score≤9) received randomly escitalopram 10 mg, 20 mg, 30 mg or nortriptyline 100 mg as monotherapies and were followed for 6 months in a multicentre double-blind set-up. Primary endpoint was relapse (HAM-D17≥16). Results: As inclusion rate was low the study was prematurely stopped with only 47 patients randomised (20% of the planned sample size). No statistically significant between-group differences could be detected. When all patients receiving escitalopram were compared with those receiving nortriptyline, a marginal superiority of nortriptyline was found (p=0.08). One third of patients relapsed during the study period, and one third completed. Discussion: Due to small sample size, no valid efficacy inferences could be made. The outcome was poor, probably due to tapering off of non-study psychotropic drugs after randomisation; this has implications for future study designs. ClinicalTrials.gov

U2 - 10.1055/s-0035-1565063

DO - 10.1055/s-0035-1565063

M3 - Journal article

C2 - 26529118

SN - 0176-3679

VL - 48

SP - 274

EP - 278

JO - Pharmacopsychiatry

JF - Pharmacopsychiatry

IS - 7

ER -