Major Depressive Disorder
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: 1.All participants were between 18 and 65 years of age; 2.All participants provided written informed consent; 3.All patients were diagnosed with depressive disorder or recurrent depressive disorder by at least two attending psychiatrists with the rank of associate chief physician or higher, according to the International Statistical Classification of Diseases and Related Health Problems, 10th Revision (ICD-10) criteria; 4.Who showed treatment resistance to one prior SSRI trial (adequate dose and duration of >=4 weeks), with a MADRS score remaining >=20; 5.Participants were required to have a minimum of 9 years of formal schooling to ensure adequate comprehension of study procedures and rating scales.
Exclusion criteria
Exclusion criteria: 1.Patients were excluded if they had any of the following: (1) a comorbid severe psychiatric disorder (e.g., bipolar disorder or schizophrenia); (2) cognitive or speech impairment; or (3) a history of alcohol or drug abuse within the past 6 months; 2.Exclusion criteria also covered major somatic illnesses, including uncontrolled cardiovascular, hepatic, renal, or neurological diseases, glaucoma, active thyroid disorders, cancer, and benign prostatic hyperplasia; 3.Known hypersensitivity to the study drugs; 4.Inability or unwillingness to comply with the study protocol; 5.Pregnancy, lactation, or women of childbearing potential not using effective contraception; 6.Active suicidal ideation/behavior or depressive episodes with severe psychotic features.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change from baseline in the Montgomery-?sberg Depression Rating Scale (MADRS) total score.;17-item Hamilton Depression Rating Scale (HAMD-17),; | — |
Secondary
| Measure | Time frame |
|---|---|
| The Hamilton Anxiety Rating Scale (HAMA), the Snaith-Hamilton Pleasure Scale (SHAPS), and the 36-Item Short Form Health Survey (SF-36);Change scores from baseline on the Treatment Emergent Symptom Scale (TESS).;Electrocardiogram (ECG);Laboratory tests, including complete blood count (CBC), urinalysis, blood biochemistry, human chorionic gonadotropin (hCG), and thyroid function tests (TFTs).;THINC-integrated tool; | — |
Countries
China
Contacts
Shandong Mental Health Center