Comparison of Antipsychotic Combination Treatment of Olanzapine and Amisulpride to Monotherapy
- Conditions
- SchizophreniaSchizoaffective Disorder
- Interventions
- Registration Number
- NCT01609153
- Lead Sponsor
- Heinrich-Heine University, Duesseldorf
- Brief Summary
A study to examine whether an antipsychotic combination treatment of olanzapine and amisulpride is more effective than olanzapine and amisulpride alone.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 328
- Patients with schizophrenia and schizoaffective disorder according to International Classification of Diseases (ICD-10);
- age 18-65;
- Positive and Negative Symptom Scale Total-Score ≥ 70 and two items of the positive symptom subscale ≥4.
- voluntary treatment after written informed consent
- legal capacity
- exclusion of pregnancy by laboratory test (Beta HCG)
- participation in other interventional studies with drugs or medical devices
- first episode patients
- physical disease that might have effects on the conduct or evaluation of the trial
- contraindications to medication according to experts information
- oversensitivity to active substance or other component of the drugs used
- known clozapine resistance
- suicidal ideation
- pregnancy or lactation
- which of pregnancy or absence save contraception
- dependency to sponsor or investigator
- institutionalization through judicial or regulatory order
- oversensitivity to placebo (mannite/aerosil)
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Olanzapine or Placebo Olanzapine and Amisulpride - Amisulpride or Placebo Olanzapine and Amisulpride - Olanzapine or Placebo Amisulpride - Olanzapine and Amisulpride Amisulpride - Amisulpride or Placebo Olanzapine - Olanzapine and Amisulpride Olanzapine -
- Primary Outcome Measures
Name Time Method 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) 8 weeks 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)
- Secondary Outcome Measures
Name Time Method Symptomatic improvement of schizophrenia after 16 weeks of treatment in comparison to time of inclusion of patient measured py PANSS total score reduction 16 weeks. To study whether a combination treatment of olanzapine and amisulpride show a PANSS total score reduction from baseline to week 16.
PANSS total score reduction from baseline to week 2 as a predictor of the change after 8 weeks 8 weeks 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 16 weeks Frequency and severity of serious adverse drug reactions
Symptomatic improvement of schizophrenia from baseline to week 2 up to week 16 measured by PANSS total score reduction. Every 2 weeks up to week 16. Whether a combination treatment of olanzapine and amisulpride show a PANSS total score reduction from baseline to every 2 weeks up to week 16.
Change of clinical condition measured by Clinical Global Impression Scale (CGI scale) every 2 weeks from baseline up to week 16 Whether there is a change of clinical condition measured by Clinical Global Impression Scale (CGI scale)
Change of the subjective well-being measured by Subjective Wellbeing under Neuroleptics Scale (SWN-K) between week 0, 8, 16 Whether there is a change of the subjective well-being measured by Subjective Wellbeing under Neuroleptics Scale(SWN-K)
Trial Locations
- Locations (21)
LWL-Klinik Dortmund
🇩🇪Dortmund, Germany
Zentrum für Seelische Gesundheit Kreiskliniken Darmstadt-Dieburg Standort: Groß-Umstadt
🇩🇪Groß-Umstadt, Germany
Universitätsmedizin Mainz Klinik für Psychiatrie und Psychotherapie
🇩🇪Mainz, Germany
Rhein-Mosel-Fachklinik Andernach
🇩🇪Andernach, Germany
Universitätsmedizin Göttingen
🇩🇪Göttingen, Germany
RWTH Aachen
🇩🇪Aachen, Germany
Rheinhessen Fachklinik Alzey
🇩🇪Alzey, Germany
Bezirkskliniken Schwaben, Bezirkskrankenhaus Augsburg
🇩🇪Augsburg, Germany
LVR-Klinikum Düsseldorf
🇩🇪Düsseldorf, Germany
Charite-Universitätsmedizin Berlin
🇩🇪Berlin, Germany
Klinik für Psychiatrie, Psychotherapie und Psychosomatik am Bezirkskrankehaus Günzburg
🇩🇪Günzburg, Germany
Universitätsklinikum Leipzig, Klinik und Poliklinik für Psychiatrie und Psychotherapie
🇩🇪Leipzig, Germany
LVR-Klinikum Köln
🇩🇪Köln, Germany
Klinik für Psychiatrie, Sozialpsychiatrie und Psychotherapie Medizinische Hochschule Hannover (MHH)
🇩🇪Hannover, Germany
Universitätsklinikum Heidelberg
🇩🇪Heidelberg, Germany
LVR-Klinik Langenfeld
🇩🇪Langenfeld, Germany
LMU München
🇩🇪München, Germany
Zentralinstitut für Seelische Gesundheit
🇩🇪Mannheim, Germany
Bezirksklinikum Regensburg, Klinik für Psychiatrie und Psychotherapie
🇩🇪Regensburg, Germany
TU München
🇩🇪München, Germany
Universitätsklinikum Würzburg
🇩🇪Würzburg, Germany