Overview

A Study on the Efficacy of Agomelatine Combined With Antipsychotics to Treat Negative Symptoms in Schizophrenia

Status:
Recruiting
Trial end date:
2023-08-01
Target enrollment:
Participant gender:
Summary
This study is a prospective, multicenter, controlled, real world study. Patients will be randomly enrolled into the test group and the control group at a ratio of 1:1 during the screening period. The test group will choose to add Agomepratin on the basis of a second-generation antipsychotic drug (olanzapine, aripiprazole, risperidone, etc., see Annex A), and the control group will either use a second-generation antipsychotic drug (olanzapine, aripiprazole, risperidone, etc.) for 24 consecutive weeks, To explore the efficacy and safety of the second generation antipsychotic drugs combined with agomeratine regimen in the real world for negative symptoms of schizophrenic patients. Group sequential design is used as the method of interim analysis in the research process. If the research purpose is reached in advance, the research can be terminated. The study followed GRACE standards.
Phase:
Phase 4
Details
Lead Sponsor:
Shanghai Mental Health Center
Collaborator:
Tianjin Anding Hospital
Treatments:
S 20098