Major Depressive Disorder
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: 1.Outpatient or inpatient patients aged 18-55, regardless of gender.; 2.According to the M.I.N.I. 7.0.2-type interview, the patient met the diagnostic criteria for major depressive disorder in the Diagnostic and Statistical Manual of Mental Disorders Version V (DSM-5), with single or repeated episodes; 3.HAMD-17>=17 at baseline; 4.Satisfy and only satisfy any one of them (ensure that the two groups are at least moderate or above, so that a positive result can be made): (1)The criteria for depression/anhedonia, either anhedonia (MARDS item 8=4) or mood anhedonia (MARDS item 1 or 2=6), and at least three of the following symptoms:Psychomotor disorders (HAMD 8 or 9=2 points), decreased appetite or body mass (HAMD 12 or 16=2 points), early wakefulness (HAMD 6=1 point), and excessive self-blame (HAMD 2=2 points); (2)Criteria for anxiety depression, which was defined as HAMD score >17 and HAMA score >15.
Exclusion criteria
Exclusion criteria: 1.Have a history of neurological diseases, including head trauma, epilepsy, encephalitis, brain tumor, etc. 2.Persons currently eligible for other important psychiatric diagnoses, including neurocognitive impairment, neurodevelopmental disorder, schizophrenia, bipolar disorder, secondary depression, obsessive compulsive disorder, panic disorder, post-traumatic stress disorder, alcohol (or drug) dependence or abuse, and personality disorders; 3.Current depressive episode accompanied by psychotic symptoms; 4.High suicide risk, defined as >=3 points in item 3 of HAMD-17; 5.Patients with moderate or above EEG abnormality, or mild EEG abnormality with clinical significance; 6.Major physical diseases or unstable physical conditions; 7.Abnormal items in the subjects' vital signs, laboratory examination and ECG examination, which are judged by the investigator to have significant clinical significance, will affect the safety of the subjects or the test results; 8.Patients with metal implants, pacemakers or metal clips in the arteries; 9.Screening patients who had received ECT, TMS, VNS, DBS or light treatment within the previous 3 months; 10.Patients with refractory depression, defined as having inadequate efficacy after adequate treatment with two antidepressants;Inadequate efficacy was defined as an improvement of < 50% in the severity of major depressive disorder as measured by the Antidepressant Treatment Efficacy Questionnaire (ATRQ).Adequate antidepressant treatment is defined as antidepressant treatment at the lowest dose (or higher dose) as detailed in the ATRQ for a duration of at least 6 weeks; 11.Patients who are allergic to escitalopram oxalate, or have poor efficacy of escitalopram oxalate in the past; 12.Patients had taken monoamine oxidase inhibitors within two weeks before enrollment; 13.Pregnant or lactating women; 14.Women of reproductive age and male subjects who are unwilling or unable to take effective contraceptive measures during the trial and within 30 days after the last treatment.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| HAMD-17 depression Scale changes from baseline;magnetic resonance imaging;Subtraction of the HAMA scale relative to baseline; | — |
Secondary
| Measure | Time frame |
|---|---|
| laboratory test;therapeutic response rate;clinic remission rate;MADRS scale subtraction from baseline;SHAPS scale subtraction from baseline;QIDS-SR-16 scale subtraction from baseline;CGI scale subtraction from baseline;GAD-7 scale subtraction from baseline; | — |
Countries
China
Contacts
Beijing Anding Hospital, Capital Medical University