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Proposal 1250

Title of the Proposed Research

The relationship of treatment effects and per capita income of study countries in duloxetine trials in the treatment of depressed patients.

Lead Researcher

Markus Koesters

Affiliation

Department of Psychiatry II, Ulm University

Funding Source

There is currently no external funding for this study. External funding will be sought at public funding agencies, e.g. the German Research Foundation (DFG).

Potential Conflicts of Interest

None

Data Sharing Agreement Date

7 April 2016

Lay Summary

In the last decades, more and more trials have been moved from high income countries to low- and middle-income countries, especially to Asia, Eastern-Europe and Latin America [2, 3, 4].

This movement have been discussed with respect to ethical issues and research misconduct [e.g. 5,6], but little attention has been given to the differences in study results between low- and middle-income and high-income countries [7, 8]. Some studies indicate that there might be differences across countries [4, 7, 9]. For example, Khin et al. [4] showed that depressive patients outside North America had a better response to placebo as well as to antidepressant treatment, whereas the relative difference between medication and placebo was similar across countries. Currently, there is no systematic review looking at differential effect sizes in clinical depression studies according to country characteristics and across countries.

The current proposal aims to analyse the differences between treatment effects of duloxetine in patients with depression across countries, with emphasis on exploring the influence of country income levels on these results. This information will help to understand the validity and transferability of trials across countries and will strengthen evidence based clinical practice.

The research will utilise a meta-analytic approach to increase the statistical power and transferability of the results. We will analyse study data on country level, which allows for including data from cross-national multicenter studies. This information is commonly lacking in publication of cross-national multicenter trials.

We aim to publish the results of our research in international peer reviewed journals. Summaries of the results will be published in English and German and will be freely available on our institutional websites.

Study Data Provided

Study LILLY-F1J-US-HMFA: Duloxetine Versus Placebo in the Long-Term Treatment of Patients With Late-Life Major Depression
Study LILLY-F1J-MC-HMAI: A Double-Blind, Placebo- and Clomipramine-Controlled Study of Duloxetine in Patients with Major Depression
Study LILLY-F1J-MC-HMAT(B): Duloxetine Versus Placebo and Paroxetine in the Acute Treatment of Major Depression
Study LILLY-F1J-MC-HMDI: Duloxetine Versus Placebo in the Prevention of Recurrence of Major Depressive Disorder
Study LILLY-F1J-US-HMFS: Duloxetine Versus Placebo in Patients With Major Depressive Disorder (MDD): Assessment of Energy and Vitality in MDD
Study LILLY-F1J-EW-HMGD: Comparison of Two Different Treatment Strategies in Patients With Major Depressive Disorder Not Exhibiting Improvement on Escitalopram Treatment: Early vs. Delayed Intervention Strategy
Study LILLY-F1J-MC-HMAY(B): Duloxetine Versus Placebo and Paroxetine in the Treatment of Major Depression
Study LILLY-F1J-MC-HMBU: Duloxetine Versus Venlafaxine Extended Release in the Treatment of Major Depressive Disorder
Study LILLY-F1J-MC-HMAH: Duloxetine 20/30 mg vs. Placebo in Major Depression
Study LILLY-F1J-MC-HMDD: Duloxetine Versus Duloxetine Plus Non-Pharmacological Intervention in the Treatment of Depression
Study *BI-1208.24: Study to Assess Clinical Response of Duloxetine in Patients Hospitalized for Severe Depression
Study *BI-1208.10: Study to Evaluate the Efficacy of Duloxetine in Outpatients With Major Depressive Disorder and Pain
Study LILLY-F1J-MC-HMCK: A Double-Blind, Efficacy and Safety Study of Duloxetine Versus Placebo in the Treatment of Children and Adolescents With Major Depressive Disorder
Study LILLY-F1J-MC-HMBV: Duloxetine Versus Placebo in the Treatment of Elderly Patients With Major Depressive Disorder
Study LILLY-F1J-US-HMGR: A Phase 4, 8-week, Double-blind, Randomized, Placebo-controlled Study Evaluating the Efficacy of Duloxetine 60 mg Once Daily in Outpatients with Major Depressive Disorder and Associated Painful Physical Symptoms
Study LILLY-F1J-MC-HMDG: Switching to Duloxetine From Other Antidepressants: A Regional Multicentre Trial Comparing Two Switching Techniques
Study LILLY-F1J-US-HMGU: Duloxetine Versus Placebo in the Acute Treatment of Patients With Major Depressive Disorder and Associated Painful Physical Symptoms
Study LILLY-F1J-CR-HMGM: A Phase 4, 8-week, Double-blind, Randomized Study Comparing Switching to Duloxetine or Escitalopram in Patients With Major Depressive Disorder and Residual Apathy in the Absence of Depressed Mood

Statistical Analysis Plan

The statistical analysis plan will be added after the research is published.

Publication Citation

The publication citation will be added after the research is published.