Major depressive disorder
Conditions
Interventions
Xuhanting granules group:Xuhanting Granules in combination with SSRI antidepressants
Placebo group:Xuhanting placebo in combination with SSRI antidepressants
Sponsors
Sun Yat-sen University Affiliated Third Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: (1) Age 18-65 years (including boundary values), regardless of gender; (2) Meet the diagnostic criteria for depressive episodes according to DSM-V; (3) Meet the criteria forof qi and yin deficiency syndrome in traditional Chinese medicine; (4) Baseline Montgomery-Åsberg Depression Rating Scale (MADRS) score = 22 points; (5) Voluntarily participate in the trial and sign the informed consent form.
Exclusion criteria
Exclusion criteria: (1) Those with allergies or contraindications to the proposed medications; (2) Individuals in pregnancy, lactation, or with plans for conception during the trial period; (3) Patients who have participated in other drug clinical trials within the past 4 weeks; (4) Patients with severe physical diseases of the heart, brain, liver, kidneys, or hematopoietic system that are not well-controlled; (5) History of alcohol or other substance abuse disorders within the past 6 months; (6) Patients with a MADRS suicide item score higher than 3 points, or a history of suicidal behavior in the past year, or current strong suicidal thoughts and behaviors; (7) Patients who have undergone electroconvulsive therapy in the past 3 months; (8) Individuals previously diagnosed with schizophrenia, schizoaffective disorder, or bipolar affective disorder; (9) Patients who have shown no response to at least 2 adequate trials of antidepressant medications during any depressive episode; (10) Individuals currently undergoing any specialized ongoing psychotherapy specifically designed to treat depression; (11) Individuals previously diagnosed with neurodevelopmental delay or cognitive impairment.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Montgomery-Åsberg Depression Rating Scale score; | — |
Secondary
| Measure | Time frame |
|---|---|
| Hamilton Anxiety Rating Scale (HAMA) score;Clinical Global Impressions Scale score;Quality of Life Scale (SF-36) score;Sheehan Disability Scale score;Psychotic Disorders Questionnaire-5-item Dementia screening;Snaith-Hamilton Pleasure Scale score;TCM Syndrome Score; | — |
Countries
China
Contacts
Public ContactGuan Nianhong
Sun Yat-sen University Affiliated Third Hospital
Outcome results
None listed