Major Depressive Disorder
Conditions
Interventions
Toludesvenlafaxine hydrochloride sustained-release tablets group:toludesvenlafaxine hydrochloride sustained-release tablets treatment
Sponsors
Shanghai Mental Health Center, Shanghai Jiao Tong University School of Medicine
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1.Diagnosis of major depressive disorder (MDD) meeting the criteria of the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5); 2.Age >= 18 years, regardless of gender; 3.At least moderate depression severity, defined as a Hamilton Depression Rating Scale 17-item (HAMD-17) score>= 18 points; 4.The subject voluntarily participates in this trial and provides written informed consent.
Exclusion criteria
Exclusion criteria: 1.Known history of hypersensitivity or allergy to the investigational drug; 2.History of treatment resistance, defined as failure to respond to at least two prior adequate courses of antidepressant medications with different mechanisms of action; 3.Presence of severe self-harm behaviors, significant suicidal intent or attempts, or a score >= 3 on item 3 (suicide) of the HAMD-17 scale; 4.Diagnosis of other psychiatric disorders, personality disorders, or intellectual disability according to DSM-5 criteria, or history of substance dependence or drug abuse within the past six months; 5.Presence of severe or unstable cardiovascular, hepatic, renal, hematological, endocrine, or other systemic diseases, or relevant medical history; 6.Presence of psychotic symptoms; 7.Depressive episode secondary to other psychiatric or somatic disorders; 8.Discontinuation of monoamine oxidase inhibitors (MAOIs) for <=2 weeks prior to screening; 9.Pregnant or lactating women, women planning pregnancy, or individuals unable to practice effective contraception during the study period; 10.Any other condition considered by the investigator to be unsuitable for participation in this clinical trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Hamilton Depression Rating Scale (17-item) score; | — |
Secondary
| Measure | Time frame |
|---|---|
| Hamilton Anxiety Rating Scale score;Patient Health Questionnaire-15 score;Young Mania Rating Scale score;Epworth Sleepiness Scale score;Insomnia Severity Index score;Ford Insomnia Response to Stress Test score; | — |
Countries
China
Contacts
Public ContactZhen Wang
Shanghai Mental Health Center, Shanghai Jiao Tong University School of Medicine
Outcome results
None listed