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

niversitätsklinikum Düsseldorf0 个研究点目标入组 328 人开始时间: 2012年5月18日最近更新: 2024年8月19日

适应症

试验速览

暂无简介。

•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)

•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)

发起方

niversitätsklinikum Düsseldorf