Fluvoxamine versus fluoxetine in major depressive episode: a double-blind randomised comparison

2003 ◽  
Vol 18 (5) ◽  
pp. 379-384 ◽  
Author(s):  
Jean Dalery ◽  
Adriaan Honig
Keyword(s):  
Depressive Episode ◽  
Major Depressive Episode ◽  
Major Depressive ◽  
Double Blind

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.

Zopiclone in the treatment of insomnia in depressed patients

1995 ◽  
Vol 10 (S3) ◽  
pp. 167s-172s
Author(s):  
M Van Moffaert ◽  
C Pilate
Keyword(s):  
Early Treatment ◽  
Depressive Episode ◽  
Major Depressive Episode ◽  
Comparative Trial ◽  
Major Depressive ◽  
Double Blind ◽  
Depressed Patients ◽  
Efficacy Profile

SummaryDuring the early treatment of a major depressive episode with amitryptiline, insomnia was treated in 81 patients in a double-blind comparative trial comparing zopiclone and flunitrazepam. The study showed no major differences in the efficacy profile and showed better tolerability for zopiclone than for flunitrazepam.

Efficacy of hypericum extract Ws® 5570 compared with paroxetine in patients with a moderate major depressive episode–a subgroup analysis

2017 ◽  
Vol 41 (S1) ◽  
pp. S529-S530
Author(s):  
E. Holsboer-Trachsler ◽  
E. Seifritz ◽  
M. Hatzinger
Keyword(s):  
Subgroup Analysis ◽  
Depressive Episode ◽  
Major Depressive Episode ◽  
Rating Scale ◽  
Randomised Trial ◽  
Major Depressive ◽  
Double Blind ◽  
Moderate Depression ◽  
Symptom Intensity ◽  
Remission Rates

IntroductionVarious studies showed the efficacy and tolerability of WS® 5570 (Hyperiplant® Rx, Dr. Willmar Schwabe GmbH & Co. KG) for the treatment of acute mild-to moderate depression. Beneficial effects of WS® 5570 have been also shown in patients with moderate-to-severe depression.Objectives/aimsWe present a subgroup analysis of a double blind, randomised trial to compare the therapeutic efficacy of WS® 5570 with paroxetine in patients suffering from a major depressive episode with moderate symptom intensity. This analysis on moderately depressed patients treated with WS® 5570 tries to support the hypothesis that WS® 5570 is an effective remedy in patients with major depression and moderate symptom intensity.MethodsModerate depression was defined by a baseline Hamilton Depression Rating Scale (HAM-D) total score between 22 and 25. Sixty-four patients received, after a single blind placebo run-in phase of 3–7 days, either 3 × 300 mg/day WS® 5570 or 20 mg/day paroxetine for six weeks. The change of the HAM-D total score was used to describe the efficacy of WS® 5570 compared with paroxetine in the subgroup of patients with moderate depression.ResultsThe reduction of the HAM-D total score was significantly more pronounced in patients treated with 3 × 300 mg/day WS® 5570 compared to 20 mg/day paroxetine. After six weeks, responder (87.1%) and remission rates (60.6%) to WS® 5570 were significantly higher than to paroxetine (71%/42.4%).ConclusionsAfter six weeks, patients treated with WS® 5570 showed a higher reduction in depression severity score and yielded greater response and remission rates compared with patients treated with paroxetine.Disclosure of interestSupported by Dr. Willmar Schwabe GmbH & Co. KG, Karlsruhe, Germany

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