protocolSection identificationModule nctId: NCT06278038, orgStudyIdInfo id: NO.0057 in 2024 Ethical Review, briefTitle: Efficacy and Safety of Toludesvenlafaxine Hydrochloride Sustained-release Tablets Versus Venlafaxine Hydrochloride Sustained-release Tablets in Patients With Major Depression Disorder, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-02-29, primaryCompletionDateStruct date: 2024-12-31, completionDateStruct date: 2024-12-31, studyFirstPostDateStruct date: 2024-02-26, lastUpdatePostDateStruct date: 2024-02-29, sponsorCollaboratorsModule leadSponsor name: First Affiliated Hospital of Zhejiang University, class: OTHER, descriptionModule briefSummary: The purpose of this study is to evaluate efficacy and safety of toludesvenlafaxine hydrochloride sustained-release tablets in the treatment of major depression disorder compared to venlafaxine hydrochloride sustained-release tablets, to provide evidence-based basis for clinical rational drug use., conditionsModule conditions: Major Depression Disorder, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 80, type: ESTIMATED, armsInterventionsModule interventions name: Toludesvenlafaxine hydrochloride sustained-release tablets, interventions name: Venlafaxine hydrochloride sustained-release tablets, outcomesModule primaryOutcomes measure: Snaith-Hamilton Pleasure Scale (SHAPS) Total Score, secondaryOutcomes measure: Snaith-Hamilton Pleasure Scale (SHAPS) Total Score, secondaryOutcomes measure: Snaith-Hamilton Pleasure Scale (SHAPS) Reductive Rate, secondaryOutcomes measure: Dimensional Anhedonia Rating Scale (DARS) Score, secondaryOutcomes measure: Montgomery-Asberg Depression Rating Scale (MADRS) Score, secondaryOutcomes measure: 17-item Hamilton Depression Rating Scale (HAM-D17) Score, secondaryOutcomes measure: Sheehan Disability Scale (SDS) Score, secondaryOutcomes measure: Quality of Life Enjoyment and Satisfaction Questionnaire Short Form (Q-LES-Q-SF) Score, otherOutcomes measure: Treatment Emergent Symptom Scale (TESS) Score, otherOutcomes measure: Arizona Sexual Experience Scale (ASEX) Score, otherOutcomes measure: Count of red blood cell in blood, otherOutcomes measure: Count of white blood cell in blood, otherOutcomes measure: Count of platelet in blood, otherOutcomes measure: Concentration of hemoglobin in blood, otherOutcomes measure: Concentration of alanine aminotransferase in blood, otherOutcomes measure: Concentration of aspartate aminotransferase in blood, otherOutcomes measure: Concentration of gamma-glutamyltransferase in blood, otherOutcomes measure: Concentration of blood glucose in blood, otherOutcomes measure: Concentration of serum creatinine in blood, otherOutcomes measure: Concentration of urea in blood, otherOutcomes measure: Concentration of total cholesterol in blood, otherOutcomes measure: Concentration of high density lipoprotein in blood, otherOutcomes measure: Concentration of low density lipoprotein in blood, otherOutcomes measure: Concentration of triglyceride in blood, otherOutcomes measure: Concentration of protein in urine, otherOutcomes measure: Concentration of sugar in urine, otherOutcomes measure: Count of white blood cell in urine, otherOutcomes measure: Count of red blood cell in urine, otherOutcomes measure: ECG QT Interval, otherOutcomes measure: Changes in weight, otherOutcomes measure: Changes in pulse, otherOutcomes measure: Changes in both systolic and diastolic blood pressure, otherOutcomes measure: Changes in respiration rate, otherOutcomes measure: Changes in armpit temperature, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 65 Years, stdAges: ADULT, stdAges: OLDER_ADULT, hasResults: False