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

NCT05646264 · Status: UNKNOWN · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 220

Last updated 2022-12-12

No results posted yet for this study

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.

Conditions

Interventions

DRUG

Agomelatine

Agomepratine is added to a second-generation antipsychotic drug (olanzapine, aripiprazole, risperidone, etc.)

Sponsors & Collaborators

  • Tianjin Anding Hospital

    collaborator OTHER

  • Shanghai Mental Health Center

    lead OTHER

Principal Investigators

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-01-01
Primary Completion
2023-08-01
Completion
2023-08-01

Countries

  • China

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05646264 on ClinicalTrials.gov