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OBJECTIVE This study compared the effects of duloxetine, 60 mg/day, versus placebo on cognition, depression, and pain in elderly patients with recurrent major depressive disorder. METHOD Patients were randomly assigned (2:1) to duloxetine, 60 mg/day (N=207), or placebo (N=104) for 8 weeks in a double-blind study. The primary outcome measure was a(More)
CONTEXT Major depressive disorder causes significant morbidity and mortality. Current therapies fail to fully treat both emotional and physical symptoms of major depressive disorder. OBJECTIVE To evaluate duloxetine, a dual reuptake inhibitor of serotonin and norepinephrine, on improvement of emotional and painful physical symptoms. DESIGN Randomized,(More)
OBJECTIVE Assess the efficacy of duloxetine 60/120 mg (N = 162) once daily compared with placebo (N = 168) in the treatment of patients with fibromyalgia, during six months of treatment. METHODS This was a phase-III, randomized, double-blind, placebo-controlled, parallel-group study assessing the efficacy and safety of duloxetine. RESULTS There were no(More)
BACKGROUND The association between sympathetic activation and mortality in chronic heart failure and the favorable effect of beta blocking drugs has raised the possibility of therapeutic efficacy for central sympathetic inhibition with sustained-release (SR) moxonidine, an imidazoline receptor agonist. METHODS A randomized double-blind, placebo-controlled(More)
BACKGROUND In chronic heart failure, sympathetic activation is increased. Moxonidine acts on central nervous system receptors to decrease sympathetic activation. We investigated the dose-response relationship of a new sustained-release (SR) preparation of moxonidine and the plasma concentration of norepinephrine in patients with chronic heart failure. (More)
This analysis assessed the effects of duloxetine, a dual reuptake inhibitor of serotonin and norepinephrine, on indices of cardiovascular safety, including heart rate, blood pressure (BP), and electrocardiograms (ECGs), in a large group of clinical trial patients with depression. Data were available from 8 double-blind, randomized, placebo-controlled (n =(More)
OBJECTIVE To compare the safety and tolerability profile of duloxetine versus placebo in elderly (> or = 65 years) patients with major depressive disorder (MDD). METHODS Patients were randomized (2:1) to duloxetine 60 mg/d (once daily) (n = 207) or placebo (n = 104) for 8 weeks. Safety and tolerability measures were analyzed in the total cohort of(More)
BACKGROUND Relapse rates may be as high as 50% in people with major depressive disorder (MDD) previously treated to remission. AIMS Duloxetine, an inhibitor of serotonin and noradrenaline reuptake that is licensed in Europe, the USA and elsewhere for the treatment of depressive episodes, was evaluated with regard to its efficacy, safety and tolerability(More)
BACKGROUND Using data from a relapse prevention study of duloxetine treatment for adults with major depressive disorder (MDD), we examined demographic- and illness-related variables to identify factors that may predict relapse of MDD. METHODS Post-hoc analyses, using the Cox proportional hazards model, were performed on data from a study designed to(More)
Deriving a population pharmacokinetic model from real data is always associated with numerous assumptions. Violations of these assumptions, especially if undetected, may lead to inappropriate conclusions being made from the analysis. Routinely, only a few of the assumptions are explicitly stated and justified in the reporting of a population model. Here, we(More)