The safety of agomelatine in standard medical practice in depressed patients: A 26-week international multicentre cohort study.

Objective: The present observational cohort study documented the safety of agomelatine in current medical practice in out-patients suffering from major depressive disorder.

Method: The 6-month evolution of agomelatine-treated patients was assessed with a focus on safety (emergent adverse events, liver acceptability), severity of depression using the Clinical Global Impression Severity (CGI-S) score, and functioning measured by the Sheehan Disability Scale (SDS).

Results: A total of 8453 depressed patients from 761 centres in 6 countries were analysed (female: 67.

Agomelatine in Standard Medical Practice in Depressed Patients: Results of a 1-Year Multicentre Observational Study In France.

Background And Objectives: Non-interventional studies are a valuable source of evidence that is complementary to traditional randomised, blinded and controlled clinical trials, for evaluating antidepressants in a real-world setting. The aim of the present study was to document the use of agomelatine in current medical practice and evaluate its effectiveness and safety in outpatients prescribed agomelatine to treat their current depressive episode.

Methods: This 12-month observational French study included patients initiating agomelatine treatment.

12-week double-blind randomized multicenter study of efficacy and safety of agomelatine (25-50 mg/day) versus escitalopram (10-20 mg/day) in out-patients with severe generalized anxiety disorder.

Treatment of severely symptomatic patients with generalized anxiety disorder (GAD) raises particular concerns for clinicians. This 12-week double-blind study evaluated the efficacy of agomelatine (25-50 mg/day) in the treatment of patients with severe GAD, using escitalopram (10-20 mg) as active comparator. The primary outcome measure was the change from baseline of the total score on the Hamilton Anxiety scale (HAM-A) at week 12.

Effect of agomelatine 25-50 mg on functional outcomes in patients with major depressive disorder.

Purpose: The purpose of this work is to investigate the effect of agomelatine on functioning compared with placebo in patients suffering from Major Depressive Disorder (MDD).

Methods: Data from two randomized, parallel, double-blind, placebo-controlled short-term agomelatine trials conducted by the manufacturer, one in adult and one in older patients, that evaluated the effect on social functioning, were pooled. The short term effect of agomelatine on social functioning was assessed using the Sheehan Disability Scale (SDS), according to SDS total and sub-item scores, as well as on functional response and remission rates.

Antidepressant effect in older depressed patients: the lessons of two agomelatine trials.

The present paper reports in parallel the findings of the two phase III trials that evaluated the efficacy of agomelatine in older depressed patients. It describes how the particular methodological innovations (particularly in relation to patient selection, design and accuracy of diagnosis of depression) introduced in study 2 have improved the quality of recruitment of patients and the assay sensitivity. Study 1 lacked assay sensitivity, and among the many differences with study 2, the inclusion of unexpected mildly ill patients could have inflated the placebo response.

Efficacy and safety of agomelatine (10 or 25 mg/day) in non-depressed out-patients with generalized anxiety disorder: A 12-week, double-blind, placebo-controlled study.

Agomelatine is efficacious in reducing symptoms and preventing relapse in placebo-controlled trials in generalised anxiety disorder (GAD). Nevertheless, fixed dose studies of agomelatine in GAD have not been undertaken. To determine the minimally effective optimal dose of agomelatine in GAD, the efficacy of two doses of agomelatine (10 and 25mg/day) was investigated in a 12-week, placebo-controlled, double-blind, international study in patients with a primary diagnosis of GAD.

Sustained efficacy of agomelatine 10 mg, 25 mg, and 25-50 mg on depressive symptoms and functional outcomes in patients with major depressive disorder. A placebo-controlled study over 6 months.

This randomized placebo-controlled "dose relation study" was conducted in patients who met criteria for major depressive disorder, to evaluate the efficacy and safety of agomelatine during 24 weeks at 3 doses (i) low fixed dosage (10 mg/day, n=100 patients entered the extension period), (ii) fixed dosage (25 mg/day, n=111) and (iii) a flexible dosage with up-titration in case of insufficient improvement at week 2 (25-50 mg/day, n=115) versus placebo (n=85). Mood was evaluated using the Hamilton rating scale for depression (HAM-D17) and Clinical Global Impression (CGI) scale. The functional status was examined with the Sheehan Disability Scale (SDS).

Agomelatine or placebo as adjunctive therapy to a mood stabiliser in bipolar I depression: randomised double-blind placebo-controlled trial.

Background: Adjunctive antidepressant therapy is commonly used to treat acute bipolar depression but few studies have examined this strategy.

Aims: To examine the efficacy of agomelatine v. placebo as adjuncts to lithium or valproate in bipolar depression.

A placebo-controlled study of three agomelatine dose regimens (10 mg, 25 mg, 25-50 mg) in patients with major depressive disorder.

A randomised placebo-controlled "dose relation study" was conducted in 549 patients who met the criteria for major depressive disorder, to evaluate the efficacy and safety of three doses regimens of agomelatine during 6 weeks: low fixed dosage (10 mg/day, n=133), fixed dosage (25 mg/day, n=138) and a flexible dosage with up-titration in case of insufficient improvement at week 2 (25-50 mg/day, n=137). At last post-baseline assessment, there were significant and incremental placebo-agomelatine differences on mean HAM-D₁₇ total scores in favour of each agomelatine dose regimen (2.46 ± 0.

How to switch to agomelatine after an unsuccessful try with paroxetine or venlafaxine.

Objective/introduction: The present trial informs clinicians about switching conditions with the antidepressant agomelatine after the failure of a treatment with either paroxetine or venlafaxine.

Methods: The total number of discontinuation-emergent symptoms, according to the Discontinuation-Emergent Signs and Symptoms checklist, was compared in double-blind conditions after 3 switching options: immediate substitution or initiation of agomelatine (25 mg/day p.o.

Efficacy of agomelatine and escitalopram on depression, subjective sleep and emotional experiences in patients with major depressive disorder: a 24-wk randomized, controlled, double-blind trial.

In the present randomized, controlled, double-blind trial (12 wk treatment plus double-blind extension for 12 wk), 25-50 mg/d agomelatine (n = 164) and 10-20 mg/d escitalopram (n = 160) were compared for short- and long-term efficacy, subjective sleep and tolerability. The effects of these drugs on emotional experiences were also compared in patients having completed the Oxford Questionnaire on the Emotional Side-Effects of Antidepressants (agomelatine: n = 25; escitalopram: n = 20). Agomelatine and escitalopram similarly improved depressive symptoms, with clinically relevant score changes over 12 and 24 wk and notable percentage of remitters (week 12: 60.

Is it time to shift to better characterization of patients in trials assessing novel antidepressants? An example of two relapse prevention studies with agomelatine.

The present paper reports in parallel the findings of the two studies that evaluated the efficacy of agomelatine in preventing relapse of depression. It describes the methodological adjustments made between the first and the second trial, particularly in relation to patient selection and accuracy of diagnosis of depression. Patients with major depressive disorder who responded to an 8/10-week course of agomelatine 25-50 mg treatment were randomly assigned to receive continuation treatment with agomelatine or placebo during a 24-week, randomized, double-blind treatment period with an optional 18- or 20-week double-blind extension period.

Agomelatine facilitates positive versus negative affective processing in healthy volunteer models.

Agomelatine is a new antidepressant with a novel profile of pharmacological action. The clinical efficacy of agomelatine has been established in major depression, but its actions on emotional bias are unknown. Consequently, the current experimental study assessed the effect of agomelatine on emotional processing in healthy volunteers using an Emotional Test Battery shown to be sensitive to serotonin and noradrenaline reuptake inhibitors.

Agomelatine, the first melatonergic antidepressant: discovery, characterization and development.

Current management of major depression, a common and debilitating disorder with a high social and personal cost, is far from satisfactory. All available antidepressants act through monoaminergic mechanisms, so there is considerable interest in novel non-monoaminergic approaches for potentially improved treatment. One such strategy involves targeting melatonergic receptors, as melatonin has a key role in synchronizing circadian rhythms, which are known to be perturbed in depressed states.

The DSM-IV-based Generalized Anxiety Disorder Severity Scale: preliminary validation using data from a trial of agomelatine versus placebo.

Currently available symptom severity measures for Generalized Anxiety Disorder (GAD) are not optimal. This study investigates the reliability and validity of a new measure for GAD. The Generalized Anxiety Disorder Severity Scale (DGSS), comprising 8 DSM-IV GAD symptoms assessed in terms of frequency and intensity, was used in a trial of agomelatine versus placebo for the treatment of GAD.

Efficacy of agomelatine in generalized anxiety disorder: a randomized, double-blind, placebo-controlled study.

Background: Agomelatine is a novel agent that acts on melatonergic (MT(1), MT(2)) receptors and serotonergic (5-HT(2C)) receptors. Preclinical data and data from clinical trials in major depression suggest that agomelatine may have anxiolytic properties. A randomized, double-blind, placebo-controlled trial was designed to assess the efficacy of agomelatine in generalized anxiety disorder (GAD).

[Development of a new antidepressant : agomelatine].

There are now many potentials for the development of more effective, better tolerated, and more rapidly acting antidepressants acting in association and/or beyond the monoamine hypothesis. One of these possibilities is the development of antidepressant drugs with melatonin agonist property. This holds much promise since various affective disorders, including depression, are characterized by abnormal patterns of circadian rhythms.