Simvastatin add-on to escitalopram in patients with comorbid obesity and major depression (SIMCODE): study protocol of a multicentre, randomised, double-blind, placebo-controlled trial
| Autor: | Otte, Christian, Chae, Woo Ri, Nowacki, Jan, Kaczmarczyk, Michael, Piber, Dominique, Roepke, Stefan, Märschenz, Stefanie, Lischewski, Sandra, Schmidt, Sein, Ettrich, Barbara, Grabe, Hans Joergen, Hegerl, Ulrich, Hinkelmann, Kim, Hofmann, Tobias, Janowitz, Deborah, Junghanns, Klaus, Kahl, Kai G, Klein, Jan Philipp, Krueger, Tillmann H C, Leicht, Gregor, Prvulovic, David, Reif, Andreas, Schoettle, Daniel, Strauss, Maria, Westermair, Anna, Friede, Tim, Gold, Stefan M |
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| Přispěvatelé: | University of Zurich, Otte, Christian |
| Jazyk: | angličtina |
| Rok vydání: | 2020 |
| Předmět: |
Depressive Disorder
Major Simvastatin clinical trials Depression 610 Medicine & health 2700 General Medicine General Medicine Citalopram Berlin Treatment Outcome Double-Blind Method depression & mood disorders mental disorders 10222 Institute of Biomedical Ethics and History of Medicine Humans Multicenter Studies as Topic Obesity mental health 600 Technik Medizin angewandte Wissenschaften::610 Medizin und Gesundheit::610 Medizin und Gesundheit Randomized Controlled Trials as Topic |
| Zdroj: | BMJ Open |
| Popis: | Introduction Major depressive disorder (MDD) and obesity are both common disorders associated with significant burden of disease worldwide. Importantly, MDD and obesity often co-occur, with each disorder increasing the risk for developing the other by about 50%–60%. Statins are among the most prescribed medications with well-established safety and efficacy. Statins are recommended in primary prevention of cardiovascular disease, which has been linked to both MDD and obesity. Moreover, statins are promising candidates to treat MDD because a meta-analysis of pilot randomised controlled trials has found antidepressive effects of statins as adjunct therapy to antidepressants. However, no study so far has tested the antidepressive potential of statins in patients with MDD and comorbid obesity. Importantly, this is a difficult-to-treat population that often exhibits a chronic course of MDD and is more likely to be treatment resistant. Thus, in this confirmatory randomised controlled trial, we will determine whether add-on simvastatin to standard antidepressant medication with escitalopram is more efficacious than add-on placebo over 12 weeks in 160 patients with MDD and comorbid obesity. Methods and analysis This is a protocol for a randomised, placebo-controlled, double-blind multicentre trial with parallel-group design (phase II). One hundred and sixty patients with MDD and comorbid obesity will be randomised 1:1 to simvastatin or placebo as add-on to standard antidepressant medication with escitalopram. The primary outcome is change in the Montgomery-Åsberg Depression Rating Scale (MADRS) score from baseline to week 12. Secondary outcomes include MADRS response (defined as 50% MADRS score reduction from baseline), MADRS remission (defined as MADRS score |
| Databáze: | OpenAIRE |
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