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A Randomized Double-blind Controlled Trial to Assess the Benefits of Olanzapine and Amisulpride Combination Treatment in Acutely Ill Schizophrenia Patients. - COMBINE
A study to examine whether an antipsychotic combination treatment of olanzapine and amisulpride is more effective than olanzapine and amisulpride alone.
Polypharmacy in antipsychotic therapy is an important issue when treating patients with schizophrenia. It is not well confirmed that a combination of two antipsychotic drugs lead to therapeutic benefit in contrast to monotherapy. However there is a highly frequent practice of combining atypical non-clozapine treatment that could be due to potential benefits when seeking alternatives to a high rate of non-response in acute phase. Therefore there is a need for further trials of sufficient power to address efficacy and safety issues of this regimen. Combining two selected atypical drugs in a complementary way may minimize side-effects and enhance efficacy. In order to specify these advantages it is intend to examine approaches to combination treatment: Amisulpride and olanzapine show complementing receptor binding profiles and have shown to have efficacy and good tolerability when administered in combination in retrospective studies. The object of this trial is to study whether acutely ill patients with combination of amisulpride and olanzapine are more frequently in symptomatic remission after 8 weeks than those with olanzapine or amisulpride monotherapy.
Age
18 - 65 years
Sex
ALL
Healthy Volunteers
No
RWTH Aachen
Aachen, Germany
Rheinhessen Fachklinik Alzey
Alzey, Germany
Rhein-Mosel-Fachklinik Andernach
Andernach, Germany
Bezirkskliniken Schwaben, Bezirkskrankenhaus Augsburg
Augsburg, Germany
Charite-Universitätsmedizin Berlin
Berlin, Germany
LVR-Klinikum Köln
Cologne, Germany
LWL-Klinik Dortmund
Dortmund, Germany
LVR-Klinikum Düsseldorf
Düsseldorf, Germany
Universitätsmedizin Göttingen
Göttingen, Germany
Zentrum für Seelische Gesundheit Kreiskliniken Darmstadt-Dieburg Standort: Groß-Umstadt
Groß-Umstadt, Germany
Start Date
June 1, 2012
Primary Completion Date
April 1, 2019
Completion Date
April 1, 2019
Last Updated
April 16, 2019
328
ACTUAL participants
Olanzapine
DRUG
Amisulpride
DRUG
Olanzapine and Amisulpride
DRUG
Lead Sponsor
Heinrich-Heine University, Duesseldorf
NCT07455929
NCT06740383
Data Source & Attribution
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