Depressive disorder
Conditions
Interventions
Case group (Ameining ):None
Sponsors
Chaohu Hospital of Anhui Medical University
Eligibility
Sex/Gender
All
Age
13 Years to 65 Years
Inclusion criteria
Inclusion criteria: a) Age 13-65 years old, regardless of gender; b) meet the DSM-5 (Diagnostic and Statistical Manual of Mental Disorders 5th Edition) diagnostic criteria for depression, anxiety, sleep disorders, somatic symptoms, and related disorders, and do not have psychotic symptoms; c) Pregnancy test (urine) results for women of childbearing age were negative at screening and baseline. Male and female subjects of reproductive age agree to use effective contraception throughout the study period and for at least 28 days after their last dose of the trial drug; d) Primary school education and above; e) Understand the study content, be willing to participate in the study, and sign a written informed consent.
Exclusion criteria
Exclusion criteria: a) have other major mental disorders that meet the DSM-5 diagnostic criteria, including organic mental disorders, alcohol dependence, drug dependence/abuse, schizophrenia, bipolar disorder, etc.; b) Allergic or known agomelatine allergy; c) Patients with known chronic hepatitis with abnormal ALT and AST at baseline screening; d) History of drug abuse; e) In the investigator's judgment, there is a clear and present risk of suicide or violent behavior; f) The patient is currently accompanied by definite hallucinations, delusions and other psychiatric symptoms, using any of the positive symptom items of the Concise Psychiatric Rating Scale (BPRS) (including hallucinations, exaggerations, suspicions, and unusual thinking content) > 1 point; g) Positive urine toxicology screening at screening or baseline; h) Previous organic brain lesions or severe external injuries to the brain; i) Patients with serious heart, liver and renal insufficiency, metabolic diseases and other serious physical diseases; j) Women who are pregnant or breastfeeding; k) Failure to provide informed consent.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| ALT;AST; | — |
Secondary
| Measure | Time frame |
|---|---|
| HAMD;Hamilton anxiety scale;Pittsburgh sleep quality index; | — |
Countries
China
Contacts
Public ContactKai Zhang
Chaohu Hospital of Anhui Medical University
Outcome results
None listed