Psychische Erkrankungen in der Lebensspanne ... - DGPPN

Topic 19 G Versorgungsforschung und Gesundheitspolitik // Health services research and health care policy
gebaut. Die Anzahl der Studien zum home treatment ist gering, sie
belegen jedoch, auch im Vergleich zur stationären Therapie, die
Effizienz des Ansatzes. Home treatment zeigt eine hohe Akzeptanz
bei den Klienten, führt zu einer Erweiterung diagnostischer und
therapeutischer Möglichkeiten der Klinik und eröffnet neue gesundheitspolitische
Wege durch Verknüpfung klinischer und ambulant
/ komplementärer Ressourcen. IPB bezieht sich auf erprobte
gemeindeintegrierte angloamerikanische Akutversorgungsformen
und das skandinavische need adapted treatment. Es nutzt klinische
Erfahrungen mit multiprofessionellen Komplexleistungen.
Methode: • Verweildauerbegrenzte klinisch psychiatrische Behandlung
am Ort des Hil-febedarfs bei stationärer Behandlungsnotwendigkeit
• Nutzung aller Klinikressourcen für Diagnostik
und Therapie, soweit im jeweiligen Behandlungsfall erforderlich
• Personenzentrierte klinische Komplexleistung und Bereitstellung
individueller Therapiepläne. Die Leistungen werden in Abstimmung
mit dem Patienten – an seinen Möglichkeiten, Wünschen
und therapeutischen Notwendigkeiten orientiert – teils in seiner
Wohnung, teils im sozialen Umfeld, teils in der Klinik erbracht
• Mobiles multiprofessionelles Behandlungsteam, das individuelle
Hilfemaßnahmen in Form des Hometreatments und eine 24-stündige
klinische Verantwortung an sieben Tagen in der Woche gewährleistet
• Nutzung der Verbundressourcen, d.h. Einbeziehung
von ambulanten und komplementären Behandlungsangeboten,
deren Finanzierung aus dem Krankenhausbudget erfolgt
Diskussion / Ergebnisse: Darstellung von klinischer Wirksamkeit,
Ressourceneinsatz, Kosten, Effizienz und Perspektiven.
Freitag, 27. 11. 2009, 15.30 – 17.00 Uhr, Saal 8
S-114 Symposium
440
Psychopharmacotherapy under scrutiny
Vorsitz: E. Rüther (Feldafing), M. Schmauß (Augsburg)
001
Criteria for approval
Karl Broich (BfArM, Bonn)
Controlled, randomized, double-blind parallel-group clinical trials
are still the gold standard to establish efficacy and safety of new
medicinal products for psychiatric indications. In general at least
two positive phase-III clinical trials in a well-defined patient population
are necessary. Depending on the indication three-arm study
designs including the new active substance, active control and
placebo are preferred. In addition maintenance of efficacy has to be
established in the European community before approval. Criteria
for inclusion and exclusion of patients should assure homogeneous
populations based on international classification systems as DSM-
IV-TR or ICD-10, generalizability to everyday practice should be
possible. For these patient populations validated rating instruments
must be used to establish change in the predefined primary and
secondary endpoints. Typical examples from recent approvals of
psychopharmacological products will be presented.
002
Criteria for pharmaceutical research and development
Kai Richter (Astra Zeneca GmbH, Wedel)
An average of € 600 million is required for the research and development
of a new drug with a new molecular entity such as small
molecules, vaccines, and biologics. The development process of
an innovative drug takes approximately 12 years. Pharmaceutical
companies are making good progress towards shortening the development
times for new molecular entities. Through innovative research
and drug development significant progress in treatment options
has been made. This also applies to different psychiatric
disorders. However depression and anxiety disorders remain under-
diagnosed and under-treated, with 15 % of the population suffering
from a major depression on at least one occasion in their lives.
Pharmaceutical companies strive to translate the scientific progress
into innovations and solutions for currently unmet medical needs
for an increasing and ageing population. In neuroscience, research
projects include novel NMDA antagonists for the treatment of depression,
GABAA partial agonists for anxiety disorder and various
compounds for the treatment of chronic pain conditions. Furthermore
research & development continues to reveal novel targets for
the emerging treatment of Alzheimer‘s disease. These efforts in
pharmaceutical innovation are necessary to preserve a diversity of
treatment choices much needed by patients and physicians alike.
Such a wide choice of pharmacotherapeutic treatment options is a
precondition for the high quality in the German healthcare system.
At the same time immediate and full access to innovative therapies
in the area of psychiatric disorders has to be ensured.
003
Bias in psychopharmacological trials
Stefan Weinmann (Charité – Universitätsmedizin, Institut für Sozialmedizin,
Berlin)
Introduction: Psychopharmacological therapies are increasingly
used in psychiatry backed by randomized trials (RCTs) and metaanalyses
of RCTs. However, trial methodology is increasingly put
under scrutiny in psychopharmacotherapy. Trust in their published
results has partly been eroded in recent years.
Method: Major problems of randomized trials and meta-analyses
in psychopharmacotherapy are presented and discussed.
Discussion / Results: Besides preferential publication of po sitive
studies (publication bias) and reporting bias (publication of favourable
outcomes or subgroups only) there are problems of unblinding,
control group and rater bias in studies with antidepressants as
well as antipsychotics. In addition, the classical endpoints symptom
reduction and relapse may oversimplify the evaluation of efficacy
and effectiveness of psychiatric drugs. It appears that corporate
sponsored scientific publications have portrayed newer antidepressants
and antipsychotics in an unduly positive light. It is time to
rethink the approval and reimbursement process of psychopharmacological
therapies. Initial safety and efficacy and long-term
cost-effectiveness studies may be better performed by independent
agencies rather than by the manufacturers themselves.
004
Criteria in clinical practice
Max Schmauß (Bezirkskrankenhaus Augsburg, Ärztlicher Direktor)