Major depressive disorder (MDD) and obesity are major contributors to impaired health
worldwide. 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 randomized 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. Therefore,
we hypothesize 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. We will randomize 160 obese MDD patients at 8 recruiting centers to either
Simvastatin or placebo as add-on to Escitalopram for 12 weeks. If successful, our trial would
have immediate impact on clinical practice given the fact that Simvastatin and Escitalopram
are available as inexpensive generic drugs with established safety.
If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.
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