|
Observation of the natural course of psychopharmacological treatments. Workshop of the AGNP working group on Phase-IV-research.
Chair: B. Ahrens, Lübeck, M. Linden, Berlin
It empirically well established that treatment under routine conditions differs in many aspects from treatment under experimental conditions e.g. in controlled clinical trials. If it comes to long term treatment it is even more difficult to do controlled clinical trials, so that most evidence comes from clinical observation. It is therefore a scientific question of high importance how to organize long-term oberservation of treatment, which technical and scientific problems have to be solved and how data can be interpreted beyond clinical impression formation. The workshop will present data from different studies which apply different methodologies in order to address selected questions. The contribution by Dr. Ahrens et al. reports data from an observational study in which patients were allocated either to treatment with trimipramin or an SRI. After this run in allocation further treatment was free to the clinical decision of the treating physician. The question is whether run-in randomization is feasible and whether such a design allows to test and compare treatments for efficacy, feasibility, or economic costs. Klauder et al. will report about a two-year prospective drug utilization observation study on the treatment of schizophrenic patients with Risperidone. Patients, illness status and treatment course are closely monitored. The question is whether such a design allows judgements on treatment outcome and even more on predictors of outcome. Stieglitz presents data from a quality assurance project. Quality assurance requires treatment monitoring. The question is which indicators of treatment and even more which indicators of treatment quality can be measured, what is their reliability and validity and whether treatment can be influenced. Adli et al. address a basic methodological problem. If treatment is not homogenized by design then treatment courses become very heterogeneous. Under real life conditions treatment differs in the type and amount of drugs prescribed, duration of application, or strategy. Based on empirical data from the "Berlin Sequential Treatment Algorithm for Depressive Disorders" Adli describes parameters which allow to summarize and quantify heterogeneous treatment courses over time. Hundemer et al present data from a large drug utilization observation study on fluoxetine. Frequency and reasons for treatment drop outs can reliably be observed only when treatment mode is free running and adaptive to changing situations and demands in the course of treatment. The presentation will give an example of how to study patient compliance under routine treatment conditions. Fritze will summarize the basic topic of the workshop and talk about efficacy under different time perspectives. The underlying problem is, that treatment outcome can be very different if short term or long term criteria are the basis for evaluation.
Presenters and titles of presentation: B. Ahrens, Lübeck: One year course of patients who have initially been treated either with Trimipramin or with a SSRI Klauder C, Neuss, Albus M, München, Linden M, Berlin, Philipp M, Landshut, Rettig K, Meerbusch: Two year course of schizophrenic patients unter treatment with Risperidone Stieglitz R, Freiburg: Observation of treatment courses in the context of quality assurance programmes. Adli M, Berlin, Bauer M, Berlin, Linden M, Berlin: Parameters to describe and measure multiform pharmacological prescriptions. Hundemer H.P. Bad Homburg, Linden M, Berlin, Gothe H, Aachen: Drop out curves under Fluoxetin treatment in the course of time. Fritze J, Pulheim: The role of long term observations in the efficacy evaluation of psychotropic drugs.
Symposium Comorbidity problems in psychopharmacotherapy Chair. G. Laux, Gabersee, M. Linden, Berlin
Comorbidity is known to be an important factor to explain treatment non-response, unwanted drug reactions, or to make treatment adaptations or special treatment strategies necessary. This is true for mental or somatic comorbidity. The symposium will deal with different aspects of comorbidity and discuss their consequences for treatment course and outcome.
Presenters and titles of presentation: Hiemer V, Mainz: Interaction of different psychotropics with somatic comedication Boerner RJ, Möller HJ, München: Anxiety and depression Reischies FM, Berlin: Depression and dementia Linden M, Berlin: Somatic comorbidity in the treatment of depressed elderly. Lemke M, Lübeck. Intolerance of neuroleptics in the context of organic brain damage (HIV, demetia, alcohol abuse) Laux G, Gabersee: Axis-II-comorbidity and psychotropic treatment |