Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Olanzapine or Placebo | Active Comparator |
| |
| Amisulpride or Placebo | Active Comparator |
| |
| Olanzapine and Amisulpride | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Olanzapine | Drug | Coated tablet 5-20 mg milligram(s) per day for 16 weeks |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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) | 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) | 8 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Symptomatic improvement of schizophrenia after 16 weeks of treatment in comparison to time of inclusion of patient measured py PANSS total score reduction | To study whether a combination treatment of olanzapine and amisulpride show a PANSS total score reduction from baseline to week 16. | 16 weeks. |
| Symptomatic improvement of schizophrenia from baseline to week 2 up to week 16 measured by PANSS total score reduction. |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Christian Schmidt-Kraepelin, Dr. | Heinrich-Heine University, Duesseldorf | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| RWTH Aachen | Aachen | 52074 | Germany | |||
| Rheinhessen Fachklinik Alzey |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35276079 | Derived | Schmidt-Kraepelin C, Feyerabend S, Engelke C, Riesbeck M, Meisenzahl-Lechner E, Verde PE, Correll CU, Kluge M, Makiol C, Neff A, Lange C, Englisch S, Zink M, Langguth B, Poeppl TB, Reske D, Gouzoulis-Mayfrank E, Grunder G, Hasan A, Brockhaus-Dumke A, Jager M, Baumgartner J, Leucht S, Cordes J; COMBINE Study Group. Amisulpride and olanzapine combination treatment versus each monotherapy in acutely ill patients with schizophrenia in Germany (COMBINE): a double-blind randomised controlled trial. Lancet Psychiatry. 2022 Apr;9(4):291-306. doi: 10.1016/S2215-0366(22)00032-3. Epub 2022 Mar 8. |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Amisulpride | Drug | 200-800 mg milligram(s)per day for 16 weeks |
|
|
| Olanzapine and Amisulpride | Drug | Zyprexa: Coated tablet 5-20 mg milligram(s) per day for 16 weeks Amisulpride: Coated tablet 200-800 mg milligram(s)per day for 16 weeks |
|
|
Whether a combination treatment of olanzapine and amisulpride show a PANSS total score reduction from baseline to every 2 weeks up to week 16. |
| 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 | Whether a change of PANSS total score reduction from baseline to week 2 is a predictor of the change after 8 weeks | 8 weeks |
| Serious adverse drug reactions | Frequency and severity of serious adverse drug reactions | 16 weeks |
| Change of clinical condition measured by Clinical Global Impression Scale (CGI scale) | Whether there is a change of clinical condition measured by Clinical Global Impression Scale (CGI scale) | every 2 weeks from baseline up to week 16 |
| Change of the subjective well-being measured by Subjective Wellbeing under Neuroleptics Scale (SWN-K) | Whether there is a change of the subjective well-being measured by Subjective Wellbeing under Neuroleptics Scale(SWN-K) | between week 0, 8, 16 |
| Alzey |
| 55232 |
| Germany |
| Rhein-Mosel-Fachklinik Andernach | Andernach | 56626 | Germany |
| Bezirkskliniken Schwaben, Bezirkskrankenhaus Augsburg | Augsburg | 89156 | Germany |
| Charite-Universitätsmedizin Berlin | Berlin | 10117 | Germany |
| LVR-Klinikum Köln | Cologne | 51109 | Germany |
| LWL-Klinik Dortmund | Dortmund | 44281 | Germany |
| LVR-Klinikum Düsseldorf | Düsseldorf | 40629 | Germany |
| Universitätsmedizin Göttingen | Göttingen | 37075 | Germany |
| Zentrum für Seelische Gesundheit Kreiskliniken Darmstadt-Dieburg Standort: Groß-Umstadt | Groß-Umstadt | 64823 | Germany |
| Klinik für Psychiatrie, Psychotherapie und Psychosomatik am Bezirkskrankehaus Günzburg | Günzburg | 89312 | Germany |
| Klinik für Psychiatrie, Sozialpsychiatrie und Psychotherapie Medizinische Hochschule Hannover (MHH) | Hanover | 30625 | Germany |
| Universitätsklinikum Heidelberg | Heidelberg | 69115 | Germany |
| LVR-Klinik Langenfeld | Langenfeld | 40764 | Germany |
| Universitätsklinikum Leipzig, Klinik und Poliklinik für Psychiatrie und Psychotherapie | Leipzig | 04103 | Germany |
| Universitätsmedizin Mainz Klinik für Psychiatrie und Psychotherapie | Mainz | 55131 | Germany |
| Zentralinstitut für Seelische Gesundheit | Mannheim | 68159 | Germany |
| LMU München | München | 80336 | Germany |
| TU München | München | 81675 | Germany |
| Bezirksklinikum Regensburg, Klinik für Psychiatrie und Psychotherapie | Regensburg | 93053 | Germany |
| Universitätsklinikum Würzburg | Würzburg | 97080 | Germany |
| ID | Term |
|---|---|
| D012559 | Schizophrenia |
| D011618 | Psychotic Disorders |
| ID | Term |
|---|---|
| D019967 | Schizophrenia Spectrum and Other Psychotic Disorders |
| D001523 | Mental Disorders |
Not provided
Not provided
| ID | Term |
|---|---|
| D000077152 | Olanzapine |
| D000077582 | Amisulpride |
| ID | Term |
|---|---|
| D001569 | Benzodiazepines |
| D001552 | Benzazepines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
| D001549 | Benzamides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D001565 | Benzoates |
| D000146 | Acids, Carbocyclic |
| D002264 | Carboxylic Acids |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
Not provided
Not provided