Abstract
BackgroundIn Major Depressive Disorder (MDD), treatment outcomes with currently available strategies are often disappointing. Therefore, it is sensible to develop new strategies to increase remission rates in acutely depressed patients. Many studies reported that true drug response can be observed within 14 days (early improvement) of antidepressant treatment. The identical time course of symptom amelioration after early improvement in patients treated with antidepressants of all classes or with placebo strongly suggests a common biological mechanism, which is not specific for a particular antidepressant medication. However, the biology underlying early improvement and final treatment response is not understood and there is no established biological marker as yet, which can predict treatment response for the individual patient before initiation or during the course of antidepressant treatment. Peripheral blood markers and executive functions are particularly promising candidates as markers for the onset of action and thus the prediction of final treatment outcome in MDD.Methods/DesignThe present paper presents the rationales, objectives and methods of a multi-centre study applying close-meshed repetitive measurements of peripheral blood and neuropsychological parameters in patients with MDD and healthy controls during a study period of eight weeks for the identification of biomarkers for the onset of antidepressants' action in patients with MDD. Peripheral blood parameters and depression severity are assessed in weekly intervals from baseline to week 8, executive performance in bi-weekly intervals. Patients are participating in a randomized controlled multi-level clinical trial, healthy controls are matched according to mean age, sex and general intelligence.DiscussionThis investigation will help to identify a biomarker or a set of biomarkers with decision-making quality in the treatment of MDD in order to increase the currently disappointing remission rates of antidepressant treatment.Trial RegistrationClinicalTrials.gov: NCT00974155
Highlights
In Major Depressive Disorder (MDD), treatment outcomes with currently available strategies are often disappointing
The present paper presents the rationales, objectives and methods of two complementing clinical studies [additional scientific investigations to the “Randomised clinical trial comparing early medication change (EMC) strategy with treatment as usual (TAU) in patients with Major Depressive Disorder - the EMC trial” and “the EMC Control study"] applying repetitive measurements of peripheral blood and neuropsychological parameters in patients with MDD and healthy controls during a period of eight weeks in order to identify biomarkers for the onset of antidepressants’ action in patients with MDD
The EMC Trial is a phase IV, multi-centre, multi-step, randomized, observer-blinded, actively controlled parallel-group clinical trial to investigate for the first time prospectively, whether non-improvers after 14 days of antidepressant treatment with an early medication change (EMC) are more likely to attain remission (HAMD-17 ≤ 7) on treatment day 56 compared to patients treated according to current guideline recommendation
Summary
In Major Depressive Disorder (MDD), treatment outcomes with currently available strategies are often disappointing. The biology underlying early improvement and final treatment response is not understood and there is no established biological marker as yet, which can predict treatment response for the individual patient before initiation or during the course of antidepressant treatment. Major depressive disorder (MDD) is a severe psychiatric disease that is characterized by depressed mood and loss of interest or pleasure in daily activities, and is accompanied by weight change, sleep disturbance, fatigue, physical impairment, diminished ability to think or concentrate and a high suicide rate. Effect sizes of currently available antidepressants are rather small than medium [6,7,8] and treatment outcome remains disappointing with remission rates of maximal 37% [[9] and references inside]. It is sensible to develop new strategies to increase remission rates in acutely depressed patients
Sign-in/Register to view highlights & summary Sign-in/Register to access full text options 
Free) 
Talk to us
Join us for a 30 min session where you can share your feedback and ask us any queries you have
Schedule a call
