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
Creators: name: Otte, Christian
name: Chae, Woo Ri
name: Nowacki, Jan
name: Kaczmarczyk, Michael
name: Piber, Dominique
name: Roepke, Stefan
name: Märschenz, Stefanie
name: Lischewski, Sandra
name: Schmidt, Sein
name: Ettrich, Barbara
name: Grabe, Hans Joergen
name: Hegerl, Ulrich
name: Hinkelmann, Kim
name: Hofmann, Tobias
name: Janowitz, Deborah
name: Junghanns, Klaus
name: Kahl, Kai G.
name: Klein, Jan Philipp
name: Krueger, Tillmann H. C.
name: Leicht, Gregor
name: Prvulovic, David
name: Reif, Andreas
name: Schoettle, Daniel
name: Strauss, Maria
name: Westermair, Anna
name: Friede, Tim
name: Gold, Stefan M.
Publisher: name: Charité - Universitätsmedizin Berlin
Year: 2020
Subjects: subject: depression &amp; mood disorders
subject: clinical trials
subject: mental health
subject: 600 Technik, Medizin, angewandte Wissenschaften::610 Medizin und Gesundheit::610 Medizin und Gesundheit

description: 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-angstrom sberg 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 &lt;10), mean change in patients' self-reported Beck Depression Inventory (BDI-II) and mean change in high-density lipoprotein, low-density lipoprotein and total cholesterol from baseline to week 12. Ethics and dissemination: This protocol has been approved by the ethics committee of the federal state of Berlin (Ethik-Kommission des Landes Berlin, reference: 19/0226-EK 11) and by the relevant federal authority (Bundesinstitut fur Arzneimittel und Medizinprodukte (BfArM), reference: 4043387). Study findings will be published in peer-reviewed journals and will be presented at (inter)national conferences.