Major Depressive Disorder
Conditions
Interventions
toludesvenlafaxine hydrochloride sustained-release tablets treatment group:toludesvenlafaxine hydrochloride sustained-release tablets
Sponsors
Second Xiangya Hospital of CSU
Eligibility
Sex/Gender
All
Age
18 Years to 45 Years
Inclusion criteria
Inclusion criteria: 1. Meet the diagnostic criteria for MDD in DSM-5, and current depressive episodes meet the Mini-International Neuropsychiatric Interview, M.I.N.I.7.0.2 for single or recurrent episodes without psychotic symptoms; 2. age 18-45 years (including borderline values) and gender; 3. working full-time, part-time or in education at the time of screening; 4. at least moderate functional impairment at screening, i.e. SDS score >= 12; 5. current depressive episode severity is at least moderate, i.e. HAM-D17 score >= 18; 6. the subject has self-reported subjective cognitive impairment at screening, i.e., PDQ-D5 score >= 10; 7. not have received antidepressant medication (fluoxetine for at least 6 weeks) within 2 weeks prior to screening; 8. Subjects volunteered to participate in this trial and signed an informed consent form.
Exclusion criteria
Exclusion criteria: 1. Allergic or known hypersensitivity to the study medication; 2. Previous use of at least 2 antidepressant medications with different mechanisms of action that were ineffective despite adequate dosage and duration of treatment; 3. Those with severe self-injury, apparent suicide attempts or behaviours with a HAM-D17 entry 3 (suicide item) score of >=3; 4. those who meet the DSM-5 diagnostic criteria for other mental illnesses, personality disorders, or mental retardation, or those who have had substance dependence or substance abuse within the last six months; 5. those who have received electroconvulsive therapy (ECT) or transcranial magnetic stimulation (TMS) within 3 months prior to screening; 6. Those who have received systemic psychotherapy (interpersonal therapy, motivational therapy, cognitive behavioural therapy) within 3 months prior to screening; 7. women who are pregnant or breastfeeding or who plan to become pregnant, or who cannot guarantee effective contraception for the duration of the study; 8. patients with other diseases that are not suitable for participation in this study or other conditions that are not suitable for clinical research in the opinion of the investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| SDS score; | — |
Secondary
| Measure | Time frame |
|---|---|
| RRS score;CGI score;BSI score;THINC-it score;Q—LES—Q—SF score;SERS score;PDQ-D5 score;QIDS-SR16 score;ASEX score;HAM-D17 score;CFI score; | — |
Countries
China
Contacts
Public ContactZhang Yan
Second Xiangya Hospital of CSU
Outcome results
None listed