SIMCODE: Simvastatin as add-on therapy to antidepressant medication with escitalopram in patients with depression and obesity

A multicenter, randomized, double-blind, placebo-controlled study

Depression and obesity are among the most common illnesses worldwide and can lead to an increased risk of cardiovascular disease. Statins are now used primarily to lower elevated blood lipid levels and thus reduce vulnerability to cardiovascular disease. However, there's been initial evidence that statins might also have an additional antidepressant effect as a supplement to standard antidepressant therapy.
In a BMBF-funded study, which would be the first of its kind, we want to investigate the additional antidepressive effect of simvastatin, a widely used and generally well-tolerated drug, in depressive patients with severe obesity. To determine whether applying add-on simvastatin therapy to the standard antidepressant medication leads to an additional improvement in depression compared to add-on treatment with placebo in patients with depression and comorbid obesity, we will conduct a randomized, double-blind, placebo-controlled study in a total of seven national study centers.
Our research findings could help to deepen the knowledge of the antidepressant efficacy of simvastatin in a particularly difficult-to-treat group of severely overweight depressed patients, thereby improving the treatment of other patients who may become ill in the future.
Funding by the Federal Ministry of Research and Education (BMBF)

Contact: Are you interested in participating in the study? Please send an email (simcode-studie(at)charite.de) or call 030 450 617615.

Principle Investigator: Prof. Dr. Christian Otte (Charité Universitätsmedizin Berlin)

Study Coordination: Dr. med. Woo Ri Chae

Registrations: The study is  registered in clinicaltrials.gov (NCT04301271) and DRKS (DRKS00021119).

Publication:
Otte, C., W. R. Chae, J. Nowacki, M. Kaczmarczyk, D. Piber, S. Roepke, S. Marschenz, S. Lischewski, S. Schmidt, B. Ettrich, H. J. Grabe, U. Hegerl, K. Hinkelmann, T. Hofmann, D. Janowitz, K. Junghanns, K. G. Kahl, J. P. Klein, T. H. C. Krueger, G. Leicht, D. Prvulovic, A. Reif, D. Schoettle, M. Strauss, A. Westermair, T. Friede, and S. M. Gold. "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." BMJ Open 10, no. 12 (Dec 1 2020): e040119. https://dx.doi.org/10.1136/bmjopen-2020-040119.