PMID- 17559729
OWN - NLM
STAT- MEDLINE
DCOM- 20080709
LR  - 20220321
IS  - 1473-4877 (Electronic)
IS  - 0300-7995 (Linking)
VI  - 23
IP  - 6
DP  - 2007 Jun
TI  - Duloxetine versus escitalopram and placebo: an 8-month, double-blind trial in 
      patients with major depressive disorder.
PG  - 1303-18
AB  - BACKGROUND: Duloxetine and escitalopram were compared in an 8-month, randomized, 
      double-blind, placebo-controlled trial in adult outpatients meeting DSM-IV 
      criteria for major depressive disorder (MDD). The results regarding the primary 
      objective of the study (onset of antidepressant action) have been previously 
      published. The current paper focuses on the longer-term (8-month) comparisons of 
      efficacy and safety between duloxetine and escitalopram. RESEARCH DESIGN AND 
      METHODS: Upon completion of the 8-week, fixed-dose, placebo-controlled, 
      acute-treatment phase (duloxetine 60 mg/day (n = 273), escitalopram 10 mg/day (n 
      = 274), placebo (n = 137)), patients remaining in the duloxetine (n = 188) and 
      escitalopram (n = 208) groups were eligible for double-blind dose increases 
      (duloxetine to 120 mg/day, escitalopram to 20 mg/day), and placebo non-responders 
      were eligible for double-blind rescue to active drug. MAIN OUTCOME MEASURES: 
      Efficacy was primarily assessed using the HAMD(17). Safety/tolerability 
      assessments included spontaneously reported adverse events (AEs), overall rates 
      and reasons for discontinuation, laboratory analyses, and vital signs. RESULTS: 
      Both drugs demonstrated similar remission rates over the course of the study, 
      with the probability of remission reaching 70% (duloxetine) and 75% 
      (escitalopram) at 8 months (p = 0.44). Similar improvement was observed for both 
      duloxetine and escitalopram on efficacy measures with the exception of the sleep 
      subscale of the HAMD(17), wherein escitalopram had a statistically significant 
      advantage over duloxetine in improving sleep. Over the entire 8-month study, 
      discontinuation rates differed significantly for duloxetine (62%) compared with 
      escitalopram (55%; p = 0.02). Rates of discontinuation due to AEs did not differ 
      significantly between duloxetine (12.8%), escitalopram (12.0%), and placebo 
      (10.2%) (p > 0.05 all pairwise comparisons). AEs associated with duloxetine 
      tended to emerge early in treatment (e.g., nausea, dry mouth), whereas AEs 
      associated with escitalopram tended to emerge later in treatment (e.g., diarrhea, 
      weight increase). The incidence of sustained hypertension was similar between 
      drugs (1.5 vs. 1.1% patients for duloxetine and escitalopram, respectively). 
      Statistically significant drug differences were identified in the mean changes 
      from baseline to study endpoint for pulse (+3.05 beats per minute (bpm), 
      duloxetine; -0.89 bpm, escitalopram; p < 0.001) and systolic blood pressure 
      (+3.73 mmHg, duloxetine; +0.31 mmHg, escitalopram; p < 0.05), but not diastolic 
      blood pressure (+0.81 mmHg, duloxetine; -0.24 mmHg, escitalopram; p = 0.27). At 8 
      months, mean change in weight was significantly higher for escitalopram compared 
      with duloxetine (+0.61 kg, duloxetine; +1.83 kg, escitalopram; p < 0.05), 
      however, the incidence of treatment-emergent abnormal weight gain (> or = 7% 
      increase in weight from baseline) was similar between drugs and was significantly 
      greater for both duloxetine and escitalopram compared with placebo. LIMITATIONS: 
      Because so few patients on placebo (n = 15), in comparison to duloxetine (n = 
      104) or escitalopram (n = 123), completed the entire 8-month study, the power to 
      detect a difference between the active treatments and placebo after 8 weeks was 
      significantly decreased and very likely insufficient. CONCLUSION: Throughout the 
      8-month study, similar improvement was observed for both duloxetine and 
      escitalopram on most efficacy measures with the exception of the sleep subscale 
      of the HAMD(17). Drug differences were identified in safety/tolerability 
      measures.
FAU - Pigott, Teresa A
AU  - Pigott TA
AD  - Department of Psychiatry, University of Florida, Gainesville, FL, USA.
FAU - Prakash, Apurva
AU  - Prakash A
FAU - Arnold, Lesley M
AU  - Arnold LM
FAU - Aaronson, Scott T
AU  - Aaronson ST
FAU - Mallinckrodt, Craig H
AU  - Mallinckrodt CH
FAU - Wohlreich, Madelaine M
AU  - Wohlreich MM
LA  - eng
SI  - ClinicalTrials.gov/NCT00073411
PT  - Journal Article
PT  - Multicenter Study
PT  - Randomized Controlled Trial
PT  - Research Support, Non-U.S. Gov't
DEP - 20070427
PL  - England
TA  - Curr Med Res Opin
JT  - Current medical research and opinion
JID - 0351014
RN  - 0 (Antidepressive Agents)
RN  - 0 (Placebos)
RN  - 0 (Thiophenes)
RN  - 0DHU5B8D6V (Citalopram)
RN  - 9044SC542W (Duloxetine Hydrochloride)
SB  - IM
MH  - Adolescent
MH  - Adult
MH  - Aged
MH  - Algorithms
MH  - Antidepressive Agents/adverse effects/therapeutic use
MH  - Citalopram/adverse effects/*therapeutic use
MH  - Depressive Disorder, Major/*drug therapy
MH  - Dose-Response Relationship, Drug
MH  - Double-Blind Method
MH  - Duloxetine Hydrochloride
MH  - Female
MH  - Humans
MH  - Male
MH  - Middle Aged
MH  - Placebos
MH  - Remission Induction
MH  - Thiophenes/adverse effects/*therapeutic use
MH  - Treatment Outcome
EDAT- 2007/06/15 09:00
MHDA- 2008/07/10 09:00
CRDT- 2007/06/15 09:00
PHST- 2007/06/15 09:00 [pubmed]
PHST- 2008/07/10 09:00 [medline]
PHST- 2007/06/15 09:00 [entrez]
AID - 10.1185/030079907X188107 [doi]
PST - ppublish
SO  - Curr Med Res Opin. 2007 Jun;23(6):1303-18. doi: 10.1185/030079907X188107. Epub 
      2007 Apr 27.