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

Phase 4

Conditions: F20
F25
Schizophrenia
Schizoaffective disorders

Registration Number: DRKS00003603

Lead Sponsor: niversitätsklinikum Düsseldorf

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Complete

Sex: All

Target Recruitment: 328

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)

Study & Design

Study Type: interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Measures

Name	Time	Method
- PANSS total score reduction from baseline to week 16.<br>- PANSS total score reduction from baseline to every 2 weeks up to week 16.<br>- PANSS total score reduction from baseline to week 2 as predictor of the change after 8 weeks<br>- change of the clinical condition measured every 2 weeks by CGI from baseline up to week 16.<br>- change of the subjective well-being under therapy measured by the SWN scale between week 0, 8, 16.<br>- Frequency and severity of serious adverse drug reactions