Trial document

drksid header

DRKS-ID: DRKS00003603

Trial Description

start of 1:1-Block title

Title

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

end of 1:1-Block title

start of 1:1-Block acronym

Trial Acronym

Combine-study

end of 1:1-Block acronym

start of 1:1-Block url

URL of the Trial

[---]*

end of 1:1-Block url

start of 1:1-Block public summary

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.

end of 1:1-Block public summary

start of 1:1-Block scientific synopsis

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.

end of 1:1-Block scientific synopsis

start of 1:1-Block organizational data

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

end of 1:1-Block organizational data

start of 1:n-Block secondary IDs

Secondary IDs

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

end of 1:n-Block secondary IDs

start of 1:N-Block indications

Health Condition or Problem studied

ICD10: F20 - Schizophrenia
ICD10: F25 - Schizoaffective disorders

end of 1:N-Block indications

start of 1:N-Block interventions

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

end of 1:N-Block interventions

start of 1:1-Block design

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

end of 1:1-Block design

start of 1:1-Block primary endpoint

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.

end of 1:1-Block primary endpoint

start of 1:1-Block secondary endpoint

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

end of 1:1-Block secondary endpoint

start of 1:n-Block recruitment countries

Countries of Recruitment

DE: Germany

end of 1:n-Block recruitment countries

start of 1:n-Block recruitment locations

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

end of 1:n-Block recruitment locations

start of 1:1-Block recruitment

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

end of 1:1-Block recruitment

start of 1:1-Block inclusion criteria

Inclusion Criteria

Gender: Both, male and female
Minimum Age: 18 Years
Maximum Age: 65 Years

end of 1:1-Block inclusion criteria

start of 1:1-Block inclusion criteria add

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)

end of 1:1-Block inclusion criteria add

start of 1:1-Block exclusion criteria

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)

end of 1:1-Block exclusion criteria

start of 1:n-Block addresses

Addresses

Primary Sponsor
start of 1:1-Block address primary-sponsor
- Universitätsklinikum Düsseldorf
- Moorenstr. 5
- 40225 Düsseldorf
- Germany
end of 1:1-Block address primary-sponsor

start of 1:1-Block address contact primary-sponsor
- Telephone: [---]*
- Fax: [---]*
- E-mail: [---]*
- URL: http://www.uniklinik-duesseldorf.de
end of 1:1-Block address contact primary-sponsor
Contact for Scientific Queries
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-contact

start of 1:1-Block address contact scientific-contact
- 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
end of 1:1-Block address contact scientific-contact
Contact for Public Queries
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-contact

start of 1:1-Block address contact public-contact
- 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
end of 1:1-Block address contact public-contact

end of 1:n-Block addresses

start of 1:n-Block material support

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.)
start of 1:1-Block address materialSupport
- Bundesministerium für Bildung und Forschung Dienstsitz Bonn
- Heinemannstr. 2
- 53175 Bonn
- Germany
end of 1:1-Block address materialSupport

start of 1:1-Block address contact materialSupport
- Telephone: [---]*
- Fax: [---]*
- E-mail: [---]*
- URL: http://www.bmbf.de
end of 1:1-Block address contact materialSupport

end of 1:n-Block material support

start of 1:1-Block state

Status

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

end of 1:1-Block state

start of 1:n-Block publications

Trial Publications, Results and other Documents

[---]*

end of 1:n-Block publications

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