Major depressive disorder
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: 1. Outpatients or inpatients aged 18-65 years old (including 18 and 65 years old), male or female; 2. Meeting the Diagnostic and Statistical Manual of Mental Disorders, 5th Edition (DSM-5) criteria for major depressive disorder as assessed by the Chinese version of the Brief International Neuropsychiatric Interview (M.I.N.I.) 7.0.2, either first episode or recurrent, without psychotic symptoms; 3. Baseline Hamilton Depression Scale (HAMD-17) score >= 17; 4. The total score of HAMD-17 low motivation factor (items 1, 7, 8, 13, 14) >= 5; 5. No antidepressant treatment for at least 14 days before enrollment (fluoxetine should be discontinued for at least 28 days for patients treated with fluoxetine before enrollment); 6. I understand and voluntarily participate in this study, and I sign the informed consent.
Exclusion criteria
Exclusion criteria: 1. Current or past diagnosis of a major mental disorder other than major depressive disorder according to the DSM-5, such as neurodevelopmental disorder, neurocognitive disorder, schizophrenia and other psychotic disorders, bipolar disorder, obsessive-compulsive disorder, panic disorder, post-traumatic stress disorder, and personality disorder; 2. An episode of depression secondary to an organic mental disorder due to a systemic disease or a neurological disease, such as depression due to hypothyroidism; 3. Having a history of alcohol or drug abuse in the previous year; 4. Patients with severe or unstable cardiovascular, respiratory, hepatic, renal, endocrine, hematological or other systemic diseases considered by the investigator to be ineligible for the study; 5. Investigator's assessment of current suicide risk (HAMD-17 item 3) or suicidal behavior/attempt within 6 months before screening; 6. If the patient's physical examination and laboratory examination are abnormal and judged to be clinically significant by the investigator in the baseline period; 7. Received modified electroconvulsive therapy (MECT) 3 months before screening; 8. Stopping psychotropic drugs before screening did not reach 7 half-lives; 9. Allergic constitution (allergic to more than two substances) or allergic to the drug to be used; 10. Positive blood chorionic gonadotropin (HCG)/ urine HCG test in pregnant, lactating women, or women of childbearing age during screening; Or men of reproductive potential or women of reproductive age at the time of the trial were unable to use effective contraception; Or plan to become pregnant within 3 months of the start of the trial; 11. Patients who had participated in other drug clinical trials within 4 weeks before screening; 12. The investigator considered that he was not suitable to participate in the study for other reasons.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Low power factor of the Hamilton Depression Inventory; | — |
Secondary
| Measure | Time frame |
|---|---|
| Snaith-Hamilton Pleasure Scale;fatigue severity scale;Sheehan Disability Scale;Arizona Sexual Experience Scale; | — |
Countries
China
Contacts
Beijing Anding Hospital, Capital Medical University