Predictors of relapse in a study of duloxetine treatment for patients with generalized anxiety disorder.

Objective: Data from a relapse prevention study of duloxetine treatment for adults with generalized anxiety disorder (GAD) were examined to identify predictors of relapse.

Methods: Patients responding to 6 months of open-label duloxetine treatment were randomized to continuation with duloxetine or withdrawal to placebo for a 6-month double-blind continuation phase (duloxetine, N= 216; placebo, N= 213). Post hoc analyses compared time to GAD relapse during continuation phase by using predictor variables that included patient demographics, symptom severity measures (Hamilton Anxiety Scale Scores [HAMA], Hospital Anxiety and Depression Scale), functional outcomes, and visual analogue scale (VAS) pain measures.

Efficacy of duloxetine on painful physical symptoms in major depressive disorder for patients with clinically significant painful physical symptoms at baseline: a meta-analysis of 11 double-blind, placebo-controlled clinical trials.

Objective: To review efficacy of duloxetine for physical symptoms and depressive illness in patients with at least mild to moderate major depressive disorder (MDD; DSM-IV) and clinically significant painful physical symptoms at baseline.

Data Sources: Global database of duloxetine clinical trials (Eli Lilly and Company).

Study Selection: All 11 acute, double-blind, placebo-controlled studies of duloxetine (7 with duloxetine 60-mg doses and 4 with non-60-mg doses) in the database that used a scale to measure painful physical symptoms and were completed before March 17, 2011.

Assessing remission in major depressive disorder and generalized anxiety disorder clinical trials with the discan metric of the Sheehan disability scale.

Relatively little research has focused on the relationship between functional remission and symptomatic remission in mood and anxiety disorders. This study investigates the relationship and synchrony between symptomatic and functional remission in outpatients with major depressive disorder (MDD) and generalized anxiety disorder (GAD). Using data from three MDD (N=1419) and four GAD (N=1847) randomized, placebo-controlled duloxetine studies, we calculated the percentages of patients meeting symptomatic, functional, and combined functional-symptomatic remission criteria for each disorder.

Sexual function during long-term duloxetine treatment in patients with recurrent major depressive disorder.

Introduction: Sexual dysfunction (SD) is frequently associated with major depressive disorder (MDD) in the untreated state and may be worsened by antidepressant treatment.

Aim: We evaluated SD in duloxetine-treated patients during an MDD recurrence prevention study.

Method: Patients (N = 514) received open-label duloxetine 60-120 mg/day for up to 34 weeks.

Duloxetine in the prevention of depressive recurrences: a randomized, double-blind, placebo-controlled trial.

Objective: To assess the efficacy of duloxetine 60-120 mg once daily in the prevention of depressive recurrence in outpatients with recurrent major depressive disorder (MDD).

Method: Eligible patients with at least 3 episodes of MDD (DSM-IV diagnosis) in the past 5 years received open-label duloxetine 60-120 mg/day for up to 34 weeks. Patients meeting response criteria were then randomly assigned to either duloxetine or placebo for up to 52 weeks of double-blind maintenance treatment.

Duloxetine in the treatment of generalized anxiety disorder.

Generalized anxiety disorder (GAD) is a relatively prevalent and disabling condition. Duloxetine, an inhibitor of both serotonin and norepinephrine, was approved by the US FDA in 2007 for the treatment of GAD. Short-term efficacy of duloxetine in dosages of 60-120 mg/day has been established in four double-blind, placebo-controlled trials of 9-10 weeks duration.

Early improvement during duloxetine treatment of generalized anxiety disorder predicts response and remission at endpoint.

Because many patients do not respond to pharmacotherapy for generalized anxiety disorder (GAD), it would be beneficial to know if early response is predictive of final outcome so that timely clinical decisions can be made about augmentation or alternative treatments. This topic has not been examined with the now recommended first-line treatments (selective serotonin reuptake inhibitors and serotonin norepinephrine reuptake inhibitors) for GAD. Combined data from three 9 to 10week acute treatment, multi-center, randomized, placebo-controlled studies of duloxetine for GAD were used to explore early improvement on the Hamilton Anxiety Rating Scale (HAMA) in relation to endpoint HAMA response (> or = 50% improvement from baseline), HAMA remission (< or = 7), Clinical Global Impression-Improvement (CGI-I) response (< or = 2), and functional remission as measured by the Sheehan Disability Scale Global Functional Improvement (< or = 5).