major depressive disorder
Conditions
Interventions
Treatment Group 1:An intravenous infusion of 0.2mg/Kg S-ketamine was given at baseline, after a 1-week washing period,taking lopinavir/ritonavir(400mg/100mg+400mg/100mg), intravenous infusion of S-ket
Treatment Group 2:Intravenous S-ketamine 0.2mg/Kg was given at baseline, and after a 1-week washing period,taking lopinavir/ritonavir(400mg/100mg+400mg/100mg+400mg/100mg), intravenous infusion of S-ke
Treatment Group 3:Intravenous S-ketamine 0.2mg/Kg was given at baseline, and after a 1-week washing period,taking lopinavir/ritonavir(400mg/100mg+400mg/100mg+400mg/100mg+400mg/100mg), intravenous infu
Sponsors
Beijing Anding Hospital affiliated to Capital Medical University
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Aged 18 to 65 years; 2. According to the DSM - IV standard, concise international neurological spirit interview 5.0.0 (M.I.N.I. 5.0.0) were diagnosed with recurrent depression, the current depressive episode, HAMD - 17 score of 18 points or outpatient and hospitalized patients; Or the duration of the first attack is longer than 1 year; 3. At least one previous or current oral antidepressant drug has poor efficacy; 4. Those who are willing to sign the informed consent and complete the experiment according to the program; 5. Female subjects must meet one of the following conditions: (1) menopausal, menopause for more than 1 year; (2) In the period of childbearing age, the following conditions should be met: The serum/urine pregnancy test before enrollment was negative; Agree to use a contraceptive method that is recognized to be very effective throughout the study period and up to 1 month after the end of the last medication; Male subjects or their partners agreed to use a contraceptive method that was recognized to be highly effective throughout the study period until the end of the last dose.
Exclusion criteria
Exclusion criteria: 1. The patient is a pregnant or lactating woman; 2. Have a history of severe drug allergy or hypersensitivity; 3. Was diagnosed as a serious disease at any time before signing the informed consent, and is currently unstable, which was judged by the researcher to affect inclusion; 4. Answer "Yes" to the 4th or 5th item of C-SSRS "suicidal ideation" in the past 6 months during screening; Or have committed suicide within the past 6 months under the C-SSRS "suicidal behavior"; Or, in the investigator's judgment, a serious risk of suicide; 5. Accepted electroconvulsive treatment within 3 months prior to signing the informed consent; 6. Study on the clinical significance of obvious abnormalities found in screening phase examination; 7. the human immunodeficiency virus antibody test is positive; 8. Participating in other clinical trials, or participating in any other drug clinical trials within 3 months prior to signing the Informed Consent; 9. The results of comprehensive physical examination, vital signs, SpO2, laboratory examination (blood routine, blood biochemical, thyroid function, coagulation function, urine routine, etc.), 12-lead electrocardiogram, anteropotal chest X-ray and urinary tract color ultrasound were abnormal and clinically significant; 10. A history of drug abuse; 11. Novel coronavirus nucleic acid test positive; 12. Other circumstances considered by the investigator to be unsuitable for participation in this study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Adverse events;Physical check;Vital signs;Oxygen saturation;Electrocardiogram;Electroencephalogram;CADSS;PWC-20;VAS; | — |
Countries
China
Contacts
Public ContactGang Wang
Beijing Anding Hospital affiliated to Capital Medical University
Outcome results
None listed