Major depressive disorder
Conditions
Interventions
Ruoxin Lin 40mg group:Ruoxin Lin 40mg/day, once a day, for 8 weeks
Ruoxin Lin 80mg group:Ruoxin Lin 40mg/day, once a day, take for 1 week, and take Ruoxinlin from week 2-8 80mg/day,once a day.
Ruoxin Lin 160mg group:Ruoxin Lin 40mg/day, once a day, take for one week, and take Ruoxin Lin in the second week 80mg/day, once a day, take Ruoxinlin from week 3-8 160mg/day, once a day.
Fluoxetine 20mg group:Fluoxetine 20mg/day, once a day, for 8 weeks
Sponsors
Beijing Anding Hospital, Capital Medical University
Eligibility
Sex/Gender
All
Age
12 Years to 18 Years
Inclusion criteria
Inclusion criteria: 1. The subjects themselves and their guardians voluntarily participate in this study and are able to understand and sign an informed consent form; 2. Male and female patients aged 12 years (including threshold) to under 18 years old, with a weight of >= 40kg; 3. Patients with depression who have a current duration of depressive episodes = 6 weeks during screening (meeting the DSM-5 MDD diagnostic criteria), and confirmed using the Mini Kid Children's Edition of the Brief International Neuropsychiatric Interview for Children and Adolescents; 4.When screening and baseline, the total score of MADRS should be >= 22 points; 5.During screening and baseline, the Clinical General Impression Scale Disease Severity Scale (CGI-S) score should be >= 4 points.
Exclusion criteria
Exclusion criteria: 1.Other diseases that meet the DSM-5 diagnostic criteria, including substance related and addictive disorders (excluding nicotine or caffeine), depressive disorders caused by other physical/mental illnesses, schizophrenia spectrum and other psychiatric disorders, bipolar and related disorders, attention deficit hyperactivity disorder, obsessive-compulsive and related disorders, trauma and stress-related disorders, dissociative disorder, panic disorder, anorexia nervosa or bulimia, and personality disorders; 2.Screening individuals who have received systematic psychological therapy (interpersonal relationship therapy, cognitive-behavioral therapy) or other treatments for mental illness (such as transcranial magnetic stimulation therapy, electroconvulsive therapy, etc.) within the past 3 months; 3.Discontinuing psychotropic drugs for at least 5 half lives before randomization (monoamine oxidase inhibitors for at least 2 weeks, fluoxetine for at least 1 month); 4.Individuals with a history of allergies (defined as allergies to two or more drugs or foods) or known or suspected allergies to the investigational drug or its excipients; 5. Patients who have previously been intolerant to venlafaxine, norvenlafaxine, toludine, or fluoxetine, or who have not responded to sufficient and sufficient treatment courses; Or those who have previously used at least two antidepressant drugs with different mechanisms of action but are still ineffective after sufficient treatment; 6. Individuals with obvious suicidal attempts (defined as a score of = 4 in item 10 of the MADRS scale) or suicidal behavior within the past 6 months in the Colombian Suicide Severity Rating Scale (C-SSSRS) (with any one of the results being "yes" for "actual attempts," "interrupted attempts," or "abandoned attempts"); The situation where the physical examination, vital signs, laboratory tests, or electrocardiogram (ECG) abnormalities during screening have clinical significance and the researcher considers them unsuitable for inclusion; 8. Accompanied by serious and unstable physical diseases such as cardiovascular disease, liver disease, kidney disease, blood disease, endocrine disease, malignant tumors, etc; 9 individuals with a history of epileptic seizures (excluding seizures caused by febrile seizures in children); 10. History of gastrointestinal diseases or surgeries known to interfere with drug absorption or excretion; 11. History of elevated intraocular pressure or angle closure glaucoma in the past; 12 first-degree relatives with bipolar disorder; Individuals who have participated in other clinical trials and received interventions within the past 3 months prior to screening; 14. Other situations deemed unsuitable for participation in this study by the researchers.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Changes in the total score of Montgomery Asperger's Depression Rating Scale (MADRS) compared to baseline at the end of the 8th weekend; | — |
Secondary
| Measure | Time frame |
|---|---|
| MADRS effectiveness rate (defined as the reduction rate of MADRS total score relative to baseline = 50%);MADRS remission rate (remission defined as MADRS total score <= 12);Clinical General Impression Inventory - Overall Progress (CGI-I) Score;Changes in Clinical General Impression Scale Disease Severity Scale (CGI-S) Score from Baseline;CGI-I-level effective rate (defined as CGI-I-level score <= 2);Changes in Hamilton Anxiety Scale (HAMA) scores compared to baseline;Changes in DARS scores compared to baseline; | — |
Countries
China
Contacts
Public ContactGang Wang
Beijing Anding Hospital, Capital Medical University
Outcome results
None listed