SIMCODE clinical trials data

Patient-level data on primary and secondary endpoints of a multicenter randomized controlled trial investigating Simvastatin (40 mg/d) or placebo as add-on to escitalopram in patients with comorbid major depression and obesity. We hypothesized that Simvastatin add-on to standard antidepressant Escitalopram will improve depression to a greater extent than add-on placebo in patients with comorbid obesity and major depression. The primary outcome was change in Montgomery-Åsberg Depression Rating Scale (MADRS) score from baseline (week 0) to week 12. We randomized 161 obese MDD patients at 9 recruiting centers in Germany to either Simvastatin or placebo as add-on to Escitalopram for 12 weeks. ClinicalTrials.gov Identifier: NCT04301271.