The use of real-world evidence for evaluating the efficacy and side effects of agomelatine in the treatment of major depressive disorder

Status

Active, not recruiting

Phases

Phase 4

Study type

Observational

Source

ChiCTR

Registry ID

ChiCTR2200061464

Enrollment

Unknown

Registered

2022-06-25

Start date

2022-06-13

Completion date

Unknown

Last updated

2023-04-03

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

Conditions

major depressive disorder (MDD)

Interventions

Case series:None

Eligibility

Sex/Gender

All

Age

18 Years to 65 Years

Inclusion criteria

Inclusion criteria: 1. Inpatient or outpatient patients; 2. Aged 18-65 years; 3. Meet the DSM-5 diagnostic criteria for depression; 4. Baseline Hamilton Depression Rating Scale (HAMD-24) score >=20 points; 5. Use Agomelatine (Dimension New) as the primary antidepressant; 6. Available scales and laboratory test data are available; 7. Informed consent signed by the patient himself or his legal guardian.

Exclusion criteria

Exclusion criteria: 1. Previous history of organic mental disorders, bipolar disorder, schizophrenia, personality disorder, mental retardation, substance abuse; 2. Patients taking monoamine oxidase inhibitors and still in the drug washout period; 3. Patients who have used non-convulsive electroconvulsive therapy in the last 3 months; 4. Patients with abnormal liver function and liver disease; 5. Pregnant and lactating patients.

Design outcomes

Primary

Measure	Time frame
scores of different scales;	—

Secondary

Measure	Time frame
liver function;blood routine examination;electrocardiogram;	—

Countries

China

Contacts

Public ContactYuan Yonggui

yygylh2000@sina.com+86 13913939082

Outcome results

None listed

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