Comparison of Antipsychotic Combination Treatment of Olanzapine and Amisulpride to Monotherapy (COMBINE)

• Symptomatic improvement of schizophrenia after 8 weeks of treatment in comparison to time of inclusion of patient measured py Positive and Negative Symptom Scale (PANSS) [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
  Whether there is a symptomatic improvement of schizophrenia after 8 weeks of treatment in comparison to time of inclusion of patient measured py Positive and Negative Symptom Scale (PANSS)
  
  

• Symptomatic improvement of schizophrenia after 16 weeks of treatment in comparison to time of inclusion of patient measured py PANSS total score reduction [ Time Frame: 16 weeks. ] [ Designated as safety issue: No ]
  To study whether a combination treatment of olanzapine and amisulpride show a PANSS total score reduction from baseline to week 16.
  
  
• Symptomatic improvement of schizophrenia from baseline to week 2 up to week 16 measured by PANSS total score reduction. [ Time Frame: Every 2 weeks up to week 16. ] [ Designated as safety issue: No ]
  Whether a combination treatment of olanzapine and amisulpride show a PANSS total score reduction from baseline to every 2 weeks up to week 16.
  
  
• PANSS total score reduction from baseline to week 2 as a predictor of the change after 8 weeks [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
  Whether a change of PANSS total score reduction from baseline to week 2 is a predictor of the change after 8 weeks
  
  
• Serious adverse drug reactions [ Time Frame: 16 weeks ] [ Designated as safety issue: Yes ]
  Frequency and severity of serious adverse drug reactions
  
  
• Change of clinical condition measured by CGI scale [ Time Frame: every 2 weeks from baseline up to week 16 ] [ Designated as safety issue: No ]
  Whether there is a change of clinicla condition measured by CGI scale
  
  
• Change of the subjective well-being measured by SWN scale [ Time Frame: between week 0, 8, 16 ] [ Designated as safety issue: No ]
  Whether there is a change of the subjective well-being measured by SWN scale
  
  

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.