Major depressive disorder
Conditions
Interventions
Control Group:During the one-week run-in period, the control group was treated with memantine sustained-release capsule placebo (with the same appearance and taste as memantine sustained-release capsu
Study Group:During the one-week run-in period, the study group was treated with memantine sustained-release capsules at 14 mg/day. After the end of the run-in period, the MADRS assessment was re-condu
Test group (pre test):The study group was treated with memantine sustained-release capsules
Sponsors
Beijing Anding Hospital, Capital Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 64 Years
Inclusion criteria
Inclusion criteria: 1. Aged 18 to 64 years; 2. Meet the diagnostic criteria for major depressive disorder (MDD) in the Diagnostic and Statistical Manual of Mental Disorders, 5th Edition (DSM-5), currently in a moderate or severe depressive episode, with the current depressive episode lasting for at least 4 weeks, confirmed by the Mini-International Neuropsychiatric Interview (M.I.N.I. 7.0.2); 3. At screening baseline, the Montgomery-Åsberg Depression Rating Scale (MADRS) score is >= 26, and the Clinical Global Impression-Severity (CGI-S) score is >= 4; 4. Female subjects must have a negative serum ß-human chorionic gonadotropin (HCG) pregnancy test and a negative urine pregnancy test, and agree to comply with any applicable contraceptive requirements in the protocol; 5. Voluntarily participate in the study and sign the informed consent form.
Exclusion criteria
Exclusion criteria: 1. A history and diagnosis of other mental disorders; 2. High risk of suicide, i.e., a score of >= 4 on Item 10 of the MADRS from screening to baseline; 3. Treatment-resistant depression, organic mental disorders, and secondary depression; 4. Suffering from severe or unstable physical diseases (such as severe liver and kidney insufficiency, epilepsy, thyroid diseases, prolonged Q-T interval, diabetes mellitus, diseases with bleeding risk, etc.); 5. A history of drug abuse; drug or alcohol dependence; a history of exposure to ketamine or its enantiomers; 6. Having received the following relevant treatments within 2 weeks before screening: antidepressant treatment (fluoxetine: prohibited within 4 weeks before screening); monoamine oxidase inhibitors (MAOIs); antipsychotic drugs or psychoactive drugs (mood stabilizers, hallucinogens, etc.); 7. Having received electroconvulsive therapy or other physical therapies within 3 months; 8. Subjects who are allergic, hypersensitive, or intolerant to any component of any study drug; 9. Lactating women or women planning to become pregnant in the near future; 10. Unable to cooperate with medication administration or complete relevant data collection.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in Montgomery-Asberg Depression Rating Scale score from baseline; | — |
Secondary
| Measure | Time frame |
|---|---|
| Response Rate (Percentage of subjects with Montgomery-Asberg Depression Rating Scale score =50% reduction in Montgomery-Asberg Depression Rating Scale score);Bloodomics Biomarkers; | — |
Countries
China
Contacts
Public ContactWang Gang
Beijing Anding Hospital, Capital Medical University
Outcome results
None listed