treatment-resistant depression
Conditions
Interventions
intervention group:Toludesvenlafaxine Hydrochloride Sustained-release Tablets
Sponsors
Shandong Mental Health Center
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: 1) Age range from 18 to 65 years old (including boundary values), regardless of gender; 2) Meets the DSM-5 diagnostic criteria for depression; 3) At least two or more antidepressant drugs with different mechanisms of action have been administered in sufficient quantities and throughout the treatment course, with no significant improvement in symptoms; The Montgomery Asperger Depression Rating Scale (MADRS) score is = 24 points; 4) Participants voluntarily participate in this experiment and sign an informed consent form.
Exclusion criteria
Exclusion criteria: 1) Individuals with allergic constitution or known allergies to venlafaxine, demethyl venlafaxine, or Toludesvenlafaxine Hydrochloride; 2) Individuals who have previously used Toludesvenlafaxine Hydrochloride and lafaxine hydrochloride; 3) Individuals with serious self injury, apparent suicidal attempt or perpetrator, and a MADRS score of 10 (Suicide) = 4; 4) Screening for individuals who have received electroconvulsive therapy or transcranial magnetic stimulation therapy within the first three months; 5) Pregnant or lactating women who have planned to conceive in the near future; 6) 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; 7) Severe dysfunction of organs such as heart, liver, kidney, and lungs; 8) 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; 9) 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; 10) Individuals who have participated in other clinical trials within the first three months of screening; 11) Other researchers have determined that they are not suitable to participate in this study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change of Montgomery-Asberg Depression Rating Scale score from baseline at the end of the 8th week of treatment; | — |
Secondary
| Measure | Time frame |
|---|---|
| Change of Montgomery-Asberg Depression Rating Scale score from baseline at the end of the 2nd,4th week of treatment;Change of Hamilton Anxiety Scale score from baseline at the end of the 2nd, 4th ,8th week of treatment;Change of Dimensional Anhedonia Rating Scale score from baseline at the end of the 2nd, 4th ,8th week of treatment;Change of Quality of Life Enjoyment and Satisfaction Questionnalre, Short Form Scale score from baseline at the end of the 2nd, 4th ,8th week of treatment;Change of Sheehan Disability Scale score from baseline at the end of the 2nd, 4th ,8th week of treatment;Effectiveness and remission rate of Montgomery-Asberg Depression Rating Scale; | — |
Countries
China
Contacts
Public ContactXun Guanglei
Shandong Mental Health Center
Outcome results
None listed