Depression
Conditions
Interventions
Sponsors
Beijing Anding Hospital, Capital Medical University
Eligibility
Sex/Gender
All
Age
12 Years to 60 Years
Inclusion criteria
Inclusion criteria: 1.Participants must be aged 12 to 60 years, inclusive, with no gender restrictions. 2.Meeting the diagnostic criteria for Major Depressive Disorder (MDD) according to DSM-5 (Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition); 3.At the baseline visit, the patient's self-rated Visual Analogue Scale (VAS) score shows an improvement of >=50% compared to the period of most severe illness. (The VAS consists of a 100 mm line, with one end representing "completely illness-free" and the other end representing "the most severe illness status"); 4.At least two cognitive domains in the MCCB test have T-scores below 40; 5.Educational level of elementary school or higher; 6.Voluntary participation in this study, with informed consent signed by the subject themselves, their guardian, or legal representative.
Exclusion criteria
Exclusion criteria: 1.Diagnosis of any other disorder as defined by DSM-5, excluding the aforementioned condition, including schizophrenia, bipolar disorder, neurodevelopmental disorders, obsessive-compulsive and related disorders, trauma- and stressor-related disorders, dissociative disorders, anorexia nervosa or bulimia nervosa, personality disorders, etc.; 2.History of epileptic seizures (excluding convulsions due to febrile seizures in childhood); pregnant or lactating women; 3.Patients who have received electroconvulsive therapy within the three months prior to enrollment or are deemed by the investigator to currently require MECT treatment; patients who are currently receiving CBT psychotherapy, vortioxetine treatment, or therapies such as transcranial magnetic stimulation, vagus nerve stimulation, or deep brain stimulation at baseline and will require continuation of these treatments during the study period; 4.Those with a score of >=3 on Item 3 (Suicide) of the HAMD-17; 5.Individuals with abnormal vision (or corrected vision) or abnormal hearing; 6.Those unable to cooperate with the treatment or otherwise deemed unsuitable for participation in this trial by the investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in total score of the MATRICS Consensus Cognitive Battery (MCCB) from baseline; | — |
Secondary
| Measure | Time frame |
|---|---|
| Changes in MCCB dimension scores from baseline at 4 weeks.;Changes in total score and subscale scores of the PDQ-D from baseline;Changes in neural oscillatory EEG data at 4 weeks.; | — |
Countries
China
Contacts
Public ContactShi Xiaoning
Beijing Anding Hospital, Capital Medical University
Outcome results
None listed