Depression
Conditions
Interventions
Treatment-resistant depression group:None
Non-treatment-resistant depression group:None
Sponsors
Affiliated Kangning Hospital of Ningbo University
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Meet the diagnostic criteria for moderate or severe depressive episode according to the International Classification of Diseases, 11th Revision (ICD-11). Treatment-resistant depression (TRD): Adequate course (each medication for at least 4–8 weeks); adequate dosage (the medication must reach the dose required for treatment, with good medication adherence); failure of two or more pharmacotherapies (at least two antidepressants with different mechanisms of action or chemical structures, both ineffective after adequate dose and duration). Non-treatment-resistant depression: Depression that does not meet the above criteria for treatment-resistant depression. 2. Baseline total score >=18 on the 17-item Hamilton Depression Rating Scale (HAMD-17); 3. Meet the indications for toludesvenlafaxine as specified in its prescribing information; 4. Treatment-naïve patients or previously treated patients who have completed the required medication washout period; 5. The patient or their legal guardian has signed the informed consent form.
Exclusion criteria
Exclusion criteria: 1. Allergic to venlafaxine, desvenlafaxine, or any component of toludesvenlafaxine; 2. Individuals with severe or unstable cardiovascular, hepatic, renal, or neurological diseases; 3. Uncontrolled hypertension (systolic blood pressure >140 mmHg or diastolic blood pressure >90 mmHg); 4. Individuals with a history of seizures or high risk factors for seizures; 5. Individuals diagnosed with bipolar disorder, schizophrenia spectrum disorder, or substance use disorder; 6. Individuals with significant risk of suicide (HAMD-17 item 3 score >= 3); 7. Individuals who have recently used monoamine oxidase inhibitors and have not completed the required washout period.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Hamilton Depression Rating Scale (HAMD-17) score;Pharmacogenomic biomarker detection; | — |
Secondary
| Measure | Time frame |
|---|---|
| Adverse Event Assessment;Routine blood tests and other laboratory parameters; | — |
Countries
China
Contacts
Public ContactHouxian Ouyang
Affiliated Kangning Hospital of Ningbo University
Outcome results
None listed