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Randomised clinical trial comparing early medication change (EMC) strategy with treatment as usual (TAU) in patients with Major Depressive Disorder – the EMC trial. (BMBF)

Laufzeit: 01.01.2009 - 31.12.2013

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Kurzfassung


In Major Depressive Disorder (MDD), treatment outcomes with currently available antidepressants (ADs) and strategies are insufficient. Reflecting the traditional belief of a delayed onset of ADs’ effects, current guidelines usually recommend treatment durations of 4-8 weeks until optimisation in case of insufficient outcome. Challenging this concept, many retrospective studies showed that improvement occurs usually within the first 14 days of treatment (=early improvement) and that such...In Major Depressive Disorder (MDD), treatment outcomes with currently available antidepressants (ADs) and strategies are insufficient. Reflecting the traditional belief of a delayed onset of ADs’ effects, current guidelines usually recommend treatment durations of 4-8 weeks until optimisation in case of insufficient outcome. Challenging this concept, many retrospective studies showed that improvement occurs usually within the first 14 days of treatment (=early improvement) and that such improvement (17-item Hamilton Rating Depression Scale [HAMD17] decrease ≥ 20%) in the early course of treatment has a substantial predictive value for the final outcome. Most importantly, non-improvement (HAMD17 decrease <20%) after 14 days of treatment is highly predictive for a poor final outcome. In the EMC trial, non-improvers after 14 days of AD therapy will be randomised to our “early medication change” (EMC) strategy or treatment ac-cording to current guidelines (treatment as usual; TAU). The EMC strategy for this study schedules a first medication change on day 15; in case of non-improvement between days 15-28, a second medication change will be performed. TAU schedules one medication change after 28 days in case of non-response (HAMD17 decrease < 50%). Both interventions will last 42 days. The EMC trial is a multi-centre, randomised controlled trial to examine for the first time prospectively, whether non-improvers after 14 days of AD treatment with EMC are more likely to attain remission (HAMD17 ≤7) on treatment day 56 compared to patients treated according to TAU. The trial will be conducted in cooperation with the BMBF funded Inter-disciplinary Centre for Clinical Trials (IZKS) Mainz. If the EMC strategy leads to significantly more remit-ters, it would change treatment guidelines profoundly and significantly decrease costs associated with MDD. For additional information, see http://www.the-emc-trial.de.» weiterlesen» einklappen

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