Trial document
DRKS00003603
Trial Description
Title
A randomized double-blind controlled trial to assess the benefits of olanzapine and amisulpride combination treatment in acutely ill
schizophrenia patients.-COMBINE
Trial Acronym
Combine-study
URL of the Trial
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Brief Summary in Lay Language
Patients acutely ill with schizophrenia or schizoaffective psychosis can be treated within this study. Background of this trial is, that some patients treated with a single antipsychotic compound still suffer from psychotic symptoms. Therefore many patients are treated with several antipsychotic drugs in routine care. But up to now it is not scientifically proven that the combination treatment of two or more antipsychotic drugs is better than the therapy with only one drug. Therefore this trial compares three different treatment options: 1. the antipsychotic combination treatment of olanzapine and amisulpride, 2. olanzapine + placebo monotherapy, 3. amisulpride + placebo monotherapy.
Brief Summary in Scientific Language
Objective of the trial is to find a rationale for the antipsychotic combination therapy. For this reason the therapeutic efficiency and the occurence of adverse drug reactions in combination therapy shall be examined using the example of amisulpride and olanzapine combination therapy compared to amisulpride and olanzapine monotherapy in acutely ill schizophrenia patients. The hypothesis is that patients with combination treatment show higher improvement on the Positive and Negative Symptom Scale (PANSS) after 8 weeks.
Do you plan to share individual participant data with other researchers?
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Description IPD sharing plan:
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Organizational Data
- DRKS00003603
- 2012/05/18
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- yes
- Approved
- MC-LKP-563, Ethik-Kommission an der Medizinischen Fakultät der Heinrich-Heine-Universität Düsseldorf
Secondary IDs
- 2011-002463-20
- 4038052
Health Condition or Problem studied
- F20 - Schizophrenia
- F25 - Schizoaffective disorders
Interventions/Observational Groups
- amisulpride 400-800 mg/d + olanzapine 10-20 mg/d for 16 weeks
- amisulpride 400-800 mg/d + Placebo for 16 weeks
- olanzapine 10-20 mg/d + Placebo for 16 weeks
Characteristics
- Interventional
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- Randomized controlled trial
- Blinded
- patient/subject, investigator/therapist
- Active control (effective treament of control group)
- Treatment
- Parallel
- IV
- No
Primary Outcome
change of the PANSS total score, which shows the efficiency of treatment by reduction of acute positive and negative symptoms, from baseline to treatment week 8.
Secondary Outcome
- PANSS total score reduction from baseline to week 16.
- PANSS total score reduction from baseline to every 2 weeks up to week 16.
- PANSS total score reduction from baseline to week 2 as predictor of the change after 8 weeks
- change of the clinical condition measured every 2 weeks by CGI from baseline up to week 16.
- change of the subjective well-being under therapy measured by the SWN scale between week 0, 8, 16.
- Frequency and severity of serious adverse drug reactions
Countries of Recruitment
- Germany
Locations of Recruitment
- University Medical Center
- Medical Center
- Medical Center
- University Medical Center
- Medical Center
- University Medical Center
- Medical Center
- University Medical Center
- Medical Center
- Medical Center
- Medical Center
- University Medical Center
- Medical Center
- Medical Center
- University Medical Center
Recruitment
- Actual
- 2012/06/15
- 399
- Multicenter trial
- National
Inclusion Criteria
- Both, male and female
- 18 Years
- 65 Years
Additional Inclusion Criteria
Patients with schizophrenia and schizoaffective disorder according to ICD-10; age 18-65 years; 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; patients being able and willing to follow study procedures according to the protocol (i.e. sufficient knowledge of German language); exclusion of pregnancy by laboratory test (Beta HCG)
Exclusion Criteria
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 tria; contraindications to medication according to experts information; oversensitivity to active substance or other component of the drugs used; known clozapin resistance; suicidal ideation; pregnancy or lactation; wish of pregnancy or absence of save contraception; dependency to sponsor or investigator; institutionalization through judicial or regulatory order; oversensitivity to placebo (Mannit/Aerosil)
Addresses
-
start of 1:1-Block address primary-sponsor
- Universitätsklinikum Düsseldorf
- Moorenstr. 5
- 40225 Düsseldorf
- Germany
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- http://www.uniklinik-duesseldorf.de
end of 1:1-Block address contact primary-sponsor -
start of 1:1-Block address scientific-contact
- LVR-Klinikum Düsseldorf Kliniken der Heinrich-Heine-Universität Düsseldorf
- Mr. Dr. med. Christian Schmidt-Kraepelin
- Bergische Landstr. 2
- 40629 Düsseldorf
- Germany
end of 1:1-Block address scientific-contactstart of 1:1-Block address contact scientific-contact- 0049-(0)211-922 0
- 0049-(0)211-922 2756
- christian.schmidt-kraepelin at lvr.de
- http://www.klinikum-duesseldorf.lvr.de
end of 1:1-Block address contact scientific-contact -
start of 1:1-Block address public-contact
- LVR-Klinikum Düsseldorf Kliniken der Heinrich-Heine-Universität Düsseldorf
- Mr. Dr. med. Christian Schmidt-Kraepelin
- Bergische Landstr. 2
- 40629 Düsseldorf
- Germany
end of 1:1-Block address public-contactstart of 1:1-Block address contact public-contact- 0049-(0)211-922 0
- 0049-(0)211-922 2756
- christian.schmidt-kraepelin at lvr.de
- http://www.klinikum-duesseldorf.lvr.de
end of 1:1-Block address contact public-contact
Sources of Monetary or Material Support
-
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- Bundesministerium für Bildung und Forschung Dienstsitz Bonn
- Heinemannstr. 2
- 53175 Bonn
- Germany
end of 1:1-Block address materialSupportstart of 1:1-Block address contact materialSupport- [---]*
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- http://www.bmbf.de
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Status
- Recruiting complete, follow-up continuing
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Trial Publications, Results and other Documents
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