treatment-resistant depression
Conditions
Interventions
esketamine:intravenous infusion of esketamine (0.5mg/kg)
midazolam:intravenous infusion of midazolam (0.02mg/kg)
Sponsors
The Affiliated Brain Hospital of Guangzhou Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: (1) Male and female patients, aged 18-65 years; (2) Meeting the DSM-5 diagnostic criteria using SCID-5, including unipolar and bipolar depression; (3) Treatment-resistant depression defined as: previous inefficacy to two or more antidepressants with sufficient dosage and full period course of treatment.Sufficient dosage means more than two-thirds of maximum recommended dose (equal to imipramine dose of 150~200mg/d), full period of treatment refers to adequate treatment for more than 4 weeks. Patients who are adsorbed in chronic depression must be treated more than 8 weeks. Ineffectiveness means score-reducing rate of Hamilton Depression Scale < 30%; (4) The total score of 17 items of Hamilton Depression scale (HAMD-17) is 17 or more; (5) Primary school education or above; (6) Each participant must understand the content of the study, join in the study voluntarily and sign an informed consent.
Exclusion criteria
Exclusion criteria: (1) Diagnosed with other major mental disorders according criteria of DSM-5, including organic mental disorders, alcohol dependence, drug dependence/abuse, schizophrenia, etc; (2) With definite hallucinations, delusions and other psychiatric symptoms; (3) With suicidal ideation in the last half year or suicidal behavior in the last year; (4) Previous antidepressant treatment with ketamine; (5) Having clinically significant, uncontrolled or unstable cardiovascular, kidney, liver, gastrointestinal, blood, immune, endocrine, metabolic or lung diseases (based on medical history, clinical laboratory or ECG results, or physical examination), thereby increasing the risk of using research drugs or confusing the interpretation of research results; (6) Body mass index (BMI) 40kg/m2; (7) Any abnormal laboratory data, vital signs and physical examination results of clinical significance that interfere with safety evaluation according to the opinion of the researchers, during screening or baseline; (8) ECG (ECG) abnormalities with clinical significance during screening, including sinus bradycardia (resting heart rate = 450ms, female >= 470ms), history of congenital long QT syndrome, or risk of torsade de pointes due to family history of sudden death; (9) Uremic screening was positive at the time of screening or at baseline; (10) The serum/urine pregnancy test was positive at the time of screening or was breastfeeding or planned to become pregnant in the course of the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| efficacy; | — |
Countries
China
Contacts
Public ContactYuping Ning
The Affiliated Brain Hospital of Guangzhou Medical University
Outcome results
None listed