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W05-01 - Rationale and Design of an RCT Comparing “EMC-Strategy” with TAU in Patients with Major Depression - the EMC Trial
- A. Tadic, S. Gorbulev, N. Dahmen, C. Hiemke, D.F. Braus, J. Röschke, D. van Calker, D. Wachtlin, K. Kronfeld, T. Gorbauch, M. Seibert-Grafe, K. Lieb, EMC Study Group
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- Journal:
- European Psychiatry / Volume 25 / Issue S1 / 2010
- Published online by Cambridge University Press:
- 17 April 2020, 25-E140
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- Article
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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.
MethodsIn 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/conclusionsIf 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.
Potassium-free electrolytes and calcium supplementation in an endurance race
- T M Hess, K M Greiwe-Crandell, J E Waldron, C A Williams, M A Lopes, L S Gay, P A Harris, D S Kronfeld
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- Journal:
- Comparative Exercise Physiology / Volume 5 / Issue 1 / February 2008
- Published online by Cambridge University Press:
- 01 February 2008, pp. 33-41
- Print publication:
- February 2008
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Some of the clinical signs seen in horses during endurance races may result from increases in neuromuscular excitability and are related to plasma [K+] and [Ca++]. The present study aimed to test the following hypotheses: (1) Potassium supplementation will affect plasma [K+] and may result in clinical signs related to neuromuscular hyperexcitability during an 80 km endurance ride. (2) Plasma [Ca++] will reflect dietary cation–anion balance (DCAB) and calcium intake. Feeding with a high DCAB and high dietary calcium content (1.5% total calcium of daily ration) diets would lead to higher plasma [Ca++] during an endurance race than on feeding high DCAB diets with a moderate dietary calcium content (1% of total calcium of daily ration). The current study was undertaken during the 80 km endurance research ride in 2002 in Virginia, USA. Forty volunteer rider–horse pairs participated in the race. During the race, electrolyte mixtures with (EM+K) and without (EM − K) potassium were supplied to 18 and 22 horses, respectively. After the race, the horses receiving EM − K during the race were supplied with a recovery formula containing potassium (EM-REC). The horses were fed in addition to their own forage (hay and pasture) either their own commercial concentrate (CC; 1% calcium, n = 11) or one of two research-supplied concentrates during 3 months preceding the research ride, one concentrate rich in sugar and starch (SS; 2% calcium, n = 15) and the other rich in fat and fibre (FF; 2% calcium, n = 14). Peripheral blood samples were taken the day before, within 3 min of the arrival at the vet checks at 27, 48 and 80 km, and after 3 h of recovery. Plasma samples were analysed for pH, haematocrit (Hct), [Na+], [K+], [Cl− ], [Ca++], [Mg++], total protein (TP) and albumin [alb]. Effects of sampling times, treatments and interactions were evaluated by ANOVA in a mixed model with repeated measures and applied to the 25 horses that completed 80 km. Eliminated horses had their blood sampled before entering the elimination vet check and 3 h after elimination, and were compared with finishing horses by t-test. As the ride progressed, significant increases were found in plasma pH, [Na+], , [TP], [alb], Hct and osmolality; and decreases in [K+], [Mg++], PCO2, [Ca++] and [Cl− ]. Horses supplied with potassium-free, sodium-rich electrolyte formulae (EM − K) had 12.5% lower (P = 0.001) mean plasma [K+], 7.8% lower (P = 0.024) TP and 8.4% lower (P = 0.004) albumin at 80 km, and at 3 h after the race they had 6.8% lower (P = 0.045) TP, when compared with EM+K supplemented horses. Horses fed with SS and FF had higher [Ca++] at 27 (P = 0.027), 56 (P = 0.006) and 80 km (P = 0.022) when compared with horses fed with CC. The lower [K+] in the EM − K group, and the higher [Ca++] in the SS- and FF-supplemented horses may help prevent increases in neuromuscular excitability and related clinical signs. The lower TP and albumin indicate less dehydration in the EM − K group and could help prevent related disorders.