A Study on the Efficacy of Agomelatine Combined With Antipsychotics to Treat Negative Symptoms in Schizophrenia
Schizophrenia, Negative Symptoms in Schizophrenia
About this trial
This is an interventional treatment trial for Schizophrenia
Eligibility Criteria
Inclusion Criteria: Patients must meet all the following inclusion criteria to be included in this study: Male or female aged 18-65; Conform to the diagnostic criteria of schizophrenia in the International Statistical Classification of Diseases and Related Health Problems (ICD-10); 7 < PANSS positive symptom subscale score ≤ 28 (7 items score ≤ 4, that is, no more than moderate); PANSS negative symptom subscale score ≥ 24 and at least 2 of 3 core symptoms (emotional dullness, passive/indifferent social withdrawal and lack of spontaneity and fluency in conversation) ≥ 4 points; Calgary Schizophrenia Depression Scale (CDSS) score ≤ 18 (score of 9 items ≤ 2, that is, no more than moderate); According to the judgment of the researcher, the second-generation antipsychotic drugs (including olanzapine, risperidone, aripiprazole, etc.) can be used alone or added with agomeratine on the basis of them; To voluntarily participate in this study, you need to sign an informed consent form with the legal guardian at the same time. Exclusion Criteria: Exclude patients who meet any of the following criteria: Combined with brain organic mental disorder; Have a history of drug abuse or drug or alcohol dependence in the past 1 year; Suffering from serious basic diseases or physical diseases or diseases that may affect the assessment (such as hearing and vision disorders); Suffering from other serious mental disorders at the same time; Serious suicide attempt; Hepatitis B virus (HBV) surface antigen positive, hepatitis C virus (HCV) antibody positive, anti human immunodeficiency virus (HIV) antibody positive or serum transaminase increased ≥ the upper limit of normal value; With mental retardation; Allergies to Agomelatine or its excipients; Pregnant women, lactating women and women of childbearing age did not take contraceptive measures; Currently participating in clinical research of other drugs or medical devices; Other antidepressants (including but not limited to SSRI and SNRI drugs) other than agomeratine should be used in combination; Accompanied by severe positive symptoms or depressive symptoms; The researcher thinks it is not suitable to be included.
Sites / Locations
- Shanghai Mental Health CenterRecruiting
Arms of the Study
Arm 1
Arm 2
No Intervention
Experimental
Monotherapy group
Joint group
Single use of second-generation antipsychotic drugs (including olanzapine, risperidone, aripiprazole, etc.)
second-generation antipsychotic drugs (including olanzapine, risperidone, aripiprazole, etc.) Add Agomelatine