depression
Conditions
Interventions
Experimental group:Toludesvenlafaxine Hydrochloride Sustained-release Tablets
Sponsors
Beijing Huilongguan Hospital
Eligibility
Sex/Gender
All
Age
22 Years to 65 Years
Inclusion criteria
Inclusion criteria: 1: Age range from 22 to 65 years old (including boundary values), regardless of gender 2: Meets the DSM-5 diagnostic criteria for depression 3: 32 list of symptoms of hypomania (HCL-32)<14 4: At least 4 weeks after the initial use of a single dose of antidepressant medication, if the MADRS score is still = 24, it is considered that the current treatment is ineffective or partially effective, and the researchers consider it appropriate to switch to other antidepressants 5: The subjects voluntarily participate in this trial and sign an informed consent form.
Exclusion criteria
Exclusion criteria: 1: Individuals with allergic constitution or known allergies to venlafaxine or demethylated venlafaxine 2: Individuals with psychiatric symptoms 3: Individuals with serious self injury, apparent suicidal attempt or perpetrator, and a MADRS score of 10 (suicidal ideation) = 4 4: Individuals who have received electroconvulsive or transcranial magnetic stimulation treatment within the past 3 months 5: Individuals who combine antipsychotic drugs and mood stabilizers 6: Pregnant or lactating women who have planned to conceive in the near future 7: Existence of other chronic diseases such as severe thyroid disease, Parkinson's disease, tumors, epilepsy, severe rheumatism, personality disorders, or mental retardation, or substance dependence (excluding smoking) or drug abuse who meet the DSM-5 diagnostic criteria within the first 6 months of screening 8: Severe dysfunction of organs such as heart, liver, kidney, and lungs 9: Individuals taking MAOIs during screening 10: During screening, alanine aminotransferase (ALT) or aspartate aminotransferase (AST) were 2 times higher than the normal upper limit, and creatinine (Cr) was 1.2 times higher than the normal upper limit 11: Abnormal electrocardiogram (ECG) during screening has clinical significance and is considered unsuitable for inclusion by researchers, such as QTc interval>450 ms in males and>460 ms in females 12: Individuals who have participated in other clinical trials within the first 3 months of screening 13: Other researchers have determined that they are not suitable to participate in this study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Montgomery-Asberg Depression Rating Scale score; | — |
Secondary
| Measure | Time frame |
|---|---|
| Hamilton Anxiety Scale score;Dimensional Anhedonia Rating Scale score;ality of Life Enjoyment and Satisfaction Questionnalre, Short Form, scale score;Clinical Global Impression scale score; | — |
Countries
China
Contacts
Public ContactYang Fude
Beijing Huilongguan Hospital
Outcome results
None listed