Frequency of video gaming is associated with quality of first-time VRL performance. Video game experience may be used as trainee selection criteria for tailored concepts of VRL training programs.
BackgroundIn Major Depressive Disorder (MDD), the traditional belief of a delayed onset of antidepressants' effects has lead to the concept of current guidelines that treatment durations should be between 3-8 weeks before medication change in case of insufficient outcome. Post hoc analyses of clinical trials, however, have shown that improvement usually occurs within the first 10-14 days of treatment and that such early improvement (Hamilton Depression Rating Scale [HAMD] decrease ≥20%) has a substantial predictive value for final treatment outcome. Even more important, non-improvement (HAMD decrease <20%) after 14 days of treatment was found to be highly predictive for a poor final treatment outcome.Methods/DesignThe 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 (treatment as usual; TAU). In level 1 of the EMC trial, non-improvers after 14 days of antidepressant treatment will be randomised to an EMC strategy or 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 the first medication change after 28 days in case of non-response (HAMD-17 decrease <50%). Both interventions will last 42 days. In levels 2 and 3, EMC strategies will be compared with TAU strategies in improvers on day 14, who experience a stagnation of improvement during the course of treatment. The trial is supported by the German Federal Ministry of Education and Research (BMBF) and will be conducted in cooperation with the BMBF funded Interdisciplinary Centre Clinical Trials (IZKS) at the University Medical Centre Mainz and at six clinical trial sites in Germany.DiscussionIf the EMC strategies lead to significantly more remitters, changes of clinical practice, guidelines for the treatment of MDD as well as research settings can be expected.Trial RegistrationClincaltrials.gov Identifier: NCT00974155; EudraCT: 2008-008280-96.
Coordination Centres for Clinical Trials (Koordinierungszentren für Klinische Studien, KKS) were set up to increase the quality and number of clinical trials in Germany as well as to establish clinical trial training programs in order to improve international recognition of German clinical research. Over the past 6 years, 12 KKS have been set up at the respective universities with a public grant from the Federal Ministry of Education and Research (BMBF). Many non-clinical services have been established to ensure successful co-operation in clinical trials with clinical scientists and industry. KKS help researchers to efficiently conduct commercial and non-commercial clinical trials in various disease areas. Their expertise and infrastructure allow the university to assume sponsor responsibility in non-commercial drug trials. Because of their professional work and education activities KKS are well accepted by industry and the scientific community. Central professional trial organisations such as the KKS have been shown to be the pre-requisite for meeting the growing, manifold and complex requirements for clinical trials. Therefore they are considered essential for progress and success in clinical research.
Introduction: For Major Depression, current guidelines recommend treatment durations of 3-8 weeks until optimisation in case of insufficient outcome. Many retrospective studies indicate that improvement (HAMD-17 decrease ≥20%) occurs usually within 10-14 days and that non-improvement after 14 days of treatment is highly predictive for poor clinical outcome. Methods: In level 1 of the EMC trial, non-improvers after 14 days of antidepressant treatment will be randomised to "early medication change" (EMC) strategy or treatment according to current guidelines (TAU). EMC schedules treatment optimisations on day 15 and day 29 in case of non-improvement. TAU schedules a medication change after 28 days in case of non-response (HAMD-17 decrease < 50%). Both interventions will last 42 days. In levels 2 and 3, EMC strategies will be compared with TAU strategies in improvers on day 14, who experience a stagnation of improvement during the course of treatment. The EMC trial is a multi-centre, multi-step, randomised controlled trial investigating for the first time prospectively, whether non-improvers after 14 days of antidepressant treatment with EMC are more likely to attain remission on treatment day 56 compared to patients with TAU. The trial is funded by the German Federal Ministry of Education and Research (BMBF), will be conducted in cooperation with the BMBF supported Interdisciplinary Centre for Clinical Trials (IZKS) Mainz and at six trial sites in Germany. Results/conclusions: If the EMC strategy leads to significantly more remitters, consecutive revision of guidelines, clinical practice and research settings for the treatment of MD can be expected.
Uwe Böning, Brigitte Fritschle: Coaching fürs Business. Was Coaches, Personaler und Manager über Coaching wissen müssen. Bonn: managerSeminare, 2005, 336 S., 49,90 €.
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