scholarly journals Efficacy and safety of agomelatine given orally compared to placebo, in addition to a mood stabiliser in bipolar I patients with a current major depressive episode. An eight week randomised, double-blind, controlled, parallel group study followed by a double-blind extension treatment period up to one year

2013 ◽  
Author(s):  
Michel Bourin
Keyword(s):  
Treatment Period ◽  
Depressive Episode ◽  
Major Depressive Episode ◽  
Mood Stabiliser ◽  
Efficacy And Safety ◽  
Major Depressive ◽  
Double Blind ◽  
Parallel Group ◽  
One Year ◽  
A Current

A Novel Study Design to Systematically Explore the Impact of Trial Methodology on Psychopharmacological Treatment Outcome in Patients with Depression

2018 ◽  
Vol 52 (04) ◽  
pp. 170-174
Author(s):  
Emanuel Severus ◽  
Cathrin Sauer ◽  
Michael Bauer ◽  
Michael Ostacher ◽  
Ion-George Anghelescu
Keyword(s):  
Study Design ◽  
Depressive Episode ◽  
External Validity ◽  
Major Depressive Episode ◽  
Major Depressive ◽  
Double Blind ◽  
Double Blind Placebo ◽  
Psychopharmacological Treatment ◽  
Study Designs ◽  
The Impact

Abstract Introduction Randomized, double-blind, placebo-controlled trials were developed to draw rather unbiased conclusions regarding the efficacy of antidepressants in the treatment of a major depressive episode (internal validity), mostly with the purpose of formal approval of new compounds in this indication. However, at the same time, data suggest that the very process of randomization and blinded administrations of placebo will have a significant impact on the efficacy of the antidepressant tested and therefore may limit the external validity of results obtained from this type of studies. Therefore, there is an urgent need to systematically study the impact of randomization/placebo control/blinding on patient population, efficacy, tolerability, and external validity in the psychopharmacological treatment of patients with a major depressive episode. Methods To develop a study design that allows the systematic exploration of the impact of trial design on characteristics of included patient population and outcome. Results We propose a study design including sample size calculation and statistical analysis in which patients with a major depressive episode are randomized to 3 distinct study designs that differ with regard to control, randomization, and blindness. Discussion The results of the proposed study design may have substantial consequences when it comes to how to best interpret the results of traditional randomized, double-blind, placebo-controlled trials in the acute treatment of major depressive disorder. Furthermore, they may lead to the implementation of new study designs that may be more suitable for assessing the effectiveness of new antidepressant compounds in everyday clinical practice.

Efficacy and Safety of Fluoxetine in Treating Bipolar II Major Depressive Episode

1998 ◽  
Vol 18 (6) ◽  
pp. 435-440 ◽  
Author(s):  
Jay D. Amsterdam ◽  
Felipe Garcia-Espana ◽  
Jan Fawcett ◽  
Frederick M. Quitkin ◽  
Frederick W. Reimherr ◽  
...  
Keyword(s):  
Depressive Episode ◽  
Major Depressive Episode ◽  
Efficacy And Safety ◽  
Major Depressive ◽  
Bipolar Ii
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