Trial document

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DRKS-ID: 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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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

DRKS-ID: DRKS00003603
Date of Registration in DRKS: 2012/05/18
Date of Registration in Partner Registry or other Primary Registry: [---]*
Investigator Sponsored/Initiated Trial (IST/IIT): yes
Ethics Approval/Approval of the Ethics Committee: Approved
(leading) Ethics Committee No.: MC-LKP-563, Ethik-Kommission an der Medizinischen Fakultät der Heinrich-Heine-Universität Düsseldorf

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Secondary IDs

EudraCT-No. (for studies acc. to Drug Law): 2011-002463-20
BfArM-No.: 4038052

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Health Condition or Problem studied

ICD10: F20 - Schizophrenia
ICD10: F25 - Schizoaffective disorders

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Interventions/Observational Groups

Arm 1: amisulpride 400-800 mg/d + olanzapine 10-20 mg/d for 16 weeks
Arm 2: amisulpride 400-800 mg/d + Placebo for 16 weeks
Arm 3: olanzapine 10-20 mg/d + Placebo for 16 weeks

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Characteristics

Study Type: Interventional
Study Type Non-Interventional: [---]*
Allocation: Randomized controlled trial
Blinding: Blinded
Who is blinded: patient/subject, investigator/therapist
Control: Active control (effective treament of control group)
Purpose: Treatment
Assignment: Parallel
Phase: IV
Off-label Drug use: 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

DE: Germany

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Locations of Recruitment

University Medical Center LVR-Klinikum Düsseldorf, Düsseldorf
Medical Center LVR-Klinik Langenfeld, Langenfeld
Medical Center LVR-Klinik Köln, Köln
University Medical Center Universitätsklinikum Leipzig, Leipzig
Medical Center Bezirksklinikum Regensburg, Regensburg
University Medical Center Klinik für Psychiatrie, Psychotherapie und Psychosomatik, Aachen
Medical Center Bezirkskrankenhaus Augsburg, Klinik für Psychiatrie, Psychotherapie und Psychosomatik, Augsburg
University Medical Center Psychiatrische Klinik der Ludwig-Maximilians-Universität, München
Medical Center Zentralinstitut für Seelische Gesundheit Mannheim, Klinik für Psychiatrie und Psychotherapie , Mannheim
Medical Center Rheinhessen Fachklinik Alzey, Alzey
Medical Center LWL Klinik Dortmund, Dortmund
University Medical Center Universitätsmedizin Göttingen - Klinik für Psychiatrie und Psychotherapie, Göttingen
Medical Center Rheinmosel Fachklinik Andernach, Andernach
Medical Center Zentrum für Seelische Gesundheit, Kreisklinik Groß-Umstadt, Groß-Umstadt
University Medical Center Medizinische Hochschule Hannover, Hannover

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Recruitment

Planned/Actual: Actual
(Anticipated or Actual) Date of First Enrollment: 2012/06/15
Target Sample Size: 399
Monocenter/Multicenter trial: Multicenter trial
National/International: National

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Inclusion Criteria

Gender: Both, male and female
Minimum Age: 18 Years
Maximum Age: 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

Primary Sponsor
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- Universitätsklinikum Düsseldorf
- Moorenstr. 5
- 40225 Düsseldorf
- Germany
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- Telephone: [---]*
- Fax: [---]*
- E-mail: [---]*
- URL: http://www.uniklinik-duesseldorf.de
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Contact for Scientific Queries
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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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- Telephone: 0049-(0)211-922 0
- Fax: 0049-(0)211-922 2756
- E-mail: christian.schmidt-kraepelin at lvr.de
- URL: http://www.klinikum-duesseldorf.lvr.de
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Contact for Public Queries
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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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- Telephone: 0049-(0)211-922 0
- Fax: 0049-(0)211-922 2756
- E-mail: christian.schmidt-kraepelin at lvr.de
- URL: http://www.klinikum-duesseldorf.lvr.de
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Sources of Monetary or Material Support

Public funding institutions financed by tax money/Government funding body (German Research Foundation (DFG), Federal Ministry of Education and Research (BMBF), etc.)
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- Bundesministerium für Bildung und Forschung Dienstsitz Bonn
- Heinemannstr. 2
- 53175 Bonn
- Germany
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- Telephone: [---]*
- Fax: [---]*
- E-mail: [---]*
- URL: http://www.bmbf.de
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Status

Recruitment Status: Recruiting complete, follow-up continuing
Study Closing (LPLV): [---]*

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Trial Publications, Results and other Documents

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