protocolSection identificationModule nctId: NCT06270433, orgStudyIdInfo id: 2023-KY142-01, briefTitle: Efficacy and Safety of Toludesvenlafaxine Hydrochloride Sustained-release Tablets Versus Desvenlafaxine Succinate Sustained-release Tablets Targeting Anhedonia in Patients With Major Depression Disorder, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-02-19, primaryCompletionDateStruct date: 2024-12-31, completionDateStruct date: 2024-12-31, studyFirstPostDateStruct date: 2024-02-21, lastUpdatePostDateStruct date: 2024-04-29, sponsorCollaboratorsModule leadSponsor name: Jiangsu Province Nanjing Brain Hospital, 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 anhedonia in patients with major depression disorder compared to desvenlafaxine succinate sustained-release tablets, to provide evidence-based basis for clinical rational drug use., conditionsModule conditions: Anhedonia, 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: Desvenlafaxine succinate 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: Rating Scale for Side Effects (SERS) 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 thyroid-stimulating hormone 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, contactsLocationsModule locations facility: Nanjing Brian Hospital, status: RECRUITING, city: Nanjing, state: Jiangsu, zip: 210024, country: China, contacts name: Hao Tang, MD, role: CONTACT, phone: +8618913821366, email: tanghao997@163.com, geoPoint lat: 32.06167, lon: 118.77778, hasResults: False