Major depression
Conditions
Interventions
experimental group:naltrexone+esketamine
control group:placebo+esketamine
Sponsors
The Affiliated Brain Hospital of Guangzhou Medical University
Eligibility
Sex/Gender
All
Age
16 Years to 65 Years
Inclusion criteria
Inclusion criteria: 1.Aged 16-65 years; 2.Patients diagnosed as a nonpsychotic major depressive episode as part of either major disorder or bipolar II disorder by screening DSM-5; 3.Patients with 22 or more MADRS scores; 4.For the patients with suicidal ideation at present, the score of item 10 of MADRS suicidal ideation scale is more than or equal to 1. Or patients with treatment-resistant depression (defined as failure to respond to adequate, full course of antidepressant medication with at least 2 different treatment mechanisms. Ineffectiveness was defined as patients reporting less than 50% improvement in depressive symptoms; 5.The subjects who understand the content of the study are willing to join the study and sign the written informed consent.
Exclusion criteria
Exclusion criteria: 1.Patients with other mental disorders diagnosed by DSM-5; 2.Patients with history of nervous system diseases such as epilepsy and dementia; 3.Patients with clinically significant and uncontrolled cardiovascular, kidney, liver and other physical diseases (judged according to history, physical examination or auxiliary examination); 4.Patients with contraindications to ketamine or naltrexone; 5.Pregnancy or lactation; 6.Patients with positive urine toxicology screening; 7.Concurrent abuse or dependence of other drugs (except alcohol) within the last 3 months.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Montgomery-Asberg Depression Rating Scale; | — |
Countries
China
Contacts
Public ContactChen Jialing
The Affiliated Brain Hospital of Guangzhou Medical University
Outcome results
None listed