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A retrospective study for the liver safety of agomelatine in the treatment of depression in the real world was analyzed based on the big data model algorithm

A retrospective study for the liver safety of agomelatine in the treatment of depression in the real world was analyzed based on the big data model algorithm

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2000031387
Enrollment
Unknown
Registered
2020-03-29
Start date
2020-07-01
Completion date
Unknown
Last updated
2020-03-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Depressive disorder

Interventions

drug group:N/A
Active control group:N/A

Sponsors

Peking University Sixth Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 75 Years

Inclusion criteria

Inclusion criteria: (1) aged 18-75, male or female, outpatient or inpatient; (2) patients diagnosed as having a single or repeated depressive episode, depression with sleep disturbance, or psychotic depression according to the tenth edition of the international classification of diseases (icd-10); (3) patients who met the second inclusion criteria and received agomelatine for the first time; (4) patients who met the second inclusion criteria and used other antidepressants (SSRI, SNRI, NaSSA) for the first time; (5) the research objects included in the early stage formed "knowledge" through the later stage of big data modeling, mining, evaluation and optimization, and then extracted the patients who used agomelatine and liver protection drugs at the same time; (6) variables such as the unique identification number, gender, age, medication name and time of the study population were extracted from the database; (7) in this study, patient information was anonymized; (8) pass the ethical review by the ethics committee.

Exclusion criteria

Exclusion criteria: Patients who were not considered suitable to participate in the study in conjunction with other investigators.

Design outcomes

Primary

MeasureTime frame
MAMD-17?CGI-S?CGI-I;AST?ALT;

Secondary

MeasureTime frame
electrocardiography;Routine blood examination (white blood cells, red blood cells, neutrophils, lymphocytes);Coagulation routine (partial thrombin time, prothrombin time, international standardized ratio, thrombin time);PSQI, ASEX;

Countries

China

Contacts

Public ContactSi Tianmei

Peking University Sixth Hospital

si.tian-mei@163.com+86 13910987793

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026