Trial document




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  DRKS00003603

Trial Description

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Title

A randomized double-blind controlled trial to assess the benefits of olanzapine and amisulpride combination treatment in acutely ill
schizophrenia patients.-COMBINE

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Trial Acronym

Combine-study

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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.

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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.

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Organizational Data

  •   DRKS00003603
  •   2012/05/18
  •   [---]*
  •   yes
  •   Approved
  •   MC-LKP-563, Ethik-Kommission an der Medizinischen Fakultät der Heinrich-Heine-Universität Düsseldorf
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Secondary IDs

  •   2011-002463-20 
  •   4038052 
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Health Condition or Problem studied

  •   F20 -  Schizophrenia
  •   F25 -  Schizoaffective disorders
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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
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Characteristics

  •   Interventional
  •   [---]*
  •   Randomized controlled trial
  •   Blinded
  •   patient/subject, investigator/therapist
  •   Active control (effective treament of control group)
  •   Treatment
  •   Parallel
  •   IV
  •   No
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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.

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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

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Countries of Recruitment

  •   Germany
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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 
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Recruitment

  •   Actual
  •   2012/06/15
  •   399
  •   Multicenter trial
  •   National
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Inclusion Criteria

  •   Both, male and female
  •   18   Years
  •   65   Years
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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)

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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)

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Addresses

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    • Universitätsklinikum Düsseldorf
    • Moorenstr. 5
    • 40225  Düsseldorf
    • Germany
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    • LVR-Klinikum Düsseldorf Kliniken der Heinrich-Heine-Universität Düsseldorf
    • Mr.  Dr. med.  Christian  Schmidt-Kraepelin 
    • Bergische Landstr. 2
    • 40629  Düsseldorf
    • Germany
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    • LVR-Klinikum Düsseldorf Kliniken der Heinrich-Heine-Universität Düsseldorf
    • Mr.  Dr. med.  Christian  Schmidt-Kraepelin 
    • Bergische Landstr. 2
    • 40629  Düsseldorf
    • Germany
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Sources of Monetary or Material Support

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    • Bundesministerium für Bildung und Forschung Dienstsitz Bonn
    • Heinemannstr. 2
    • 53175  Bonn
    • Germany
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Status

  •   Recruiting complete, follow-up continuing
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Trial Publications, Results and other Documents

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* This entry means the parameter is not applicable or has not been set.