Long-term safety, tolerability, and efficacy of duloxetine in the treatment of fibromyalgia.

Objectives: To assess the long-term safety, tolerability, and efficacy of duloxetine in patients with fibromyalgia.

Methods: We report results from the 6-month extension phases of 2 randomized, double-blind, placebo-controlled clinical trials having 6-month placebo-controlled phases. In Study 1, all patients received duloxetine 120 mg/d after 28 weeks on placebo or duloxetine 60 or 120 mg/d.

Safety and tolerability of duloxetine at 60 mg once daily in elderly patients with major depressive disorder.

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 patients, as well as in subgroups defined by age and preexisting hypertension.

Duloxetine in practice-based clinical settings: assessing effects on the emotional and physical symptoms of depression in an open-label, multicenter study.

Objective: In placebo-controlled clinical trials, duloxetine has been shown to be effective and well-tolerated in patients with major depressive disorder (MDD). However, patients in registration trials may not be representative of patients in clinical practice. This study sought to assess the effectiveness, safety, and tolerability of duloxetine in diverse populations of outpatients with MDD.

Efficacy of duloxetine on cognition, depression, and pain in elderly patients with major depressive disorder: an 8-week, double-blind, placebo-controlled trial.

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 prespecified composite cognitive score composed of four individual tests.

Effects of the antidepressant duloxetine on body weight: analyses of 10 clinical studies.

Objective: To assess the effect of duloxetine, an inhibitor of serotonin and norepinephrine reup-take, on body weight of patients with major depressive disorder (MDD).

Method: Body weight data were obtained from all 10 phase II and III registration studies of duloxetine in the treatment of MDD, as defined by the Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (DSM-IV), performed by Eli Lilly and Company between February 1999 and July 2003. Both acute (8-9 weeks) and long-term (26, 34, and 52 weeks) studies were analyzed.

Duloxetine in the prevention of relapse of major depressive disorder: double-blind placebo-controlled study.

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 in the prevention of relapse of MDD.

Method: Adult out-patients with MDD received duloxetine (60 mg daily) for 12 weeks (n=533).

Duloxetine in the acute and long-term treatment of major depressive disorder: a placebo- and paroxetine-controlled trial.

Background: Duloxetine is a balanced and potent dual reuptake inhibitor of serotonin (5-HT) and norepinephrine (NE) that has previously been shown to be effective in the acute treatment of major depressive disorder (MDD). This placebo-controlled study assesses the safety and efficacy of duloxetine (80 or 120 mg/day) and paroxetine (20 mg QD) during an initial 8-week acute phase and subsequent 6-month continuation phase treatment of MDD.

Method: In this randomized, double-blind, placebo-controlled trial, adult outpatients (age >or= 18 years) meeting DSM-IV criteria for MDD received placebo (n = 93), duloxetine 80 mg/day (40 mg BID; n = 95), duloxetine 120 mg/day (60 mg BID; n = 93), or paroxetine (20 mg QD; n = 86) for 8 weeks.