David G. S. Perahia, MD, MRCPsych; Deborah Quail, BS; Durisala Desaiah, PhD; Emmanuelle Corruble, MD; and Maurizio Fava, MD
Objective: To compare 2 methods of switching selective
serotonin reuptake inhibitor (SSRI) nonresponders or partial responders to
duloxetine.
Method: Adult outpatients with DSM-IV major depressive
disorder, a Hamilton Rating Scale for Depression (HAM-D17) total
score of >= 15, and a Clinical Global Impressions-Severity of Illness score of
>= 3 despite at least 6 weeks of SSRI treatment were randomly assigned to
either abrupt discontinuation of SSRI immediately followed by initiation of
duloxetine (direct switch [DS]; N = 183) or tapered discontinuation of SSRI
over 2 weeks and simultaneous administration of duloxetine (start-taper switch
[STS]; N = 185). Efficacy, safety, and tolerability outcomes associated with
these 2 switch methods were compared following switch and after 10 weeks of
duloxetine treatment. The study was conducted from August 2004 to March 2006.
Results: There was a significant improvement in depressive
symptom severity in both switch groups as measured by mean change in HAM-D17
total score (p <= .001), but no difference between the switch groups (-10.23 DS
vs. -10.49 STS). Criteria for noninferiority of the DS group to the STS group,
which was the primary objective of the study, were met. Response rates (54.4%
DS vs. 59.6% STS), remission rates (35.7% DS vs. 37.2% STS), and other
secondary outcome measures were similar for both switch groups. Few patients
discontinued the study due to adverse events (6.6% DS vs. 3.8% STS). Headache,
dry mouth, and nausea were the most frequently reported adverse events in both
switch groups.
Conclusions: Switch to duloxetine was associated with
significant improvements in both emotional and painful physical symptoms of
depression and was well tolerated and safe, regardless of which of the switch
methods was used.
J Clin Psychiatry 2008;69(1):95-105
© Copyright 2008 Physicians Postgraduate Press, Inc.