Depressive disorders, Major Depressive Disorder (MDD), Post Stroke Depression (PSD)
Conditions
Interventions
Double Sham:Sham tDCS, Sham VR-MBCT
Active tDCS + Sham VR-MBCT:Active tDCS,Sham VR-MBCT
Sham tDCS + Active VR-MBCT:Sham tDCS , Active VR-MBCT
Active tDCS + Active VR-MBCT:Active tDCS, Active VR-MBCT
Real-time adaptive closed-loop VR-MBCT combined with tDCS modulation strategy (abbreviated as the “closed-loop group”):Real-time Adaptive Closed-loop VR-MBCT Combined with tDCS Modulation
VR-MBCT combined with open-loop tDCS modulation strategy (abbreviated as the “open-loop group”):VR-MBCT combined with open-loop tDCS modulation
Sponsors
Hangzhou Seventh People's Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: The patients are Han Chinese aged between 18 (inclusive) and 65 (inclusive) years, of any gender, right-handed, meeting the Diagnostic and Statistical Manual of Mental Disorders, 5th Edition (DSM-5) criteria for mental disorders, and clinically diagnosed with Major Depressive Disorder (MDD). Patients must be in a depressive episode and have at least moderate severity, defined as a score of 17 or higher on the 17-item Hamilton Depression Rating Scale (HDRS-17). Diagnosis is conducted by psychiatrists who have received standardized training using the DSM-5 and confirmed with the Chinese version of the Structured Clinical Interview for DSM-5 (SCID-5). The remaining inclusion criteria are as follows: 1.Currently experiencing at least moderate to severe depressive episodes, with a baseline HDRS-17 score =17; 2.No antidepressant medication was administered during this course of the disease, or the maintenance regimen of antidepressant medication had been stable for at least 4 weeks. 3.No contraindications for tDCS (e.g., metal plates on the head, brain implants, cerebral aneurysm clips, cochlear implants, cardiac pacemakers, etc.); 4.No systematic psychotherapy such as MBCT, mindfulness training, or cognitive behavioral therapy has been received during current or previous depressive episodes. 5.More than 8 years of formal education experience; 6.No prior or current depression episodes treated with transcranial direct current stimulation (tDCS) or other transcranial electrical stimulation therapies. 7.Participants required to meet the indications for MRI and magnetoencephalography (MEG) data acquisition. 8.According to the investigators' assessment, the patient was able to understand and comply with the study requirements.
Exclusion criteria
Exclusion criteria: 1.Meets the criteria for treatment-resistant depression, defined as failure to respond to at least two different antidepressant agents with distinct mechanisms of action after adequate dosing and duration (at least 8 weeks at the maximum recommended therapeutic dose); 2.Other mental disorders (e.g., intellectual disability, schizophrenia, affective disorder, bipolar disorder, obsessive-compulsive disorder, attention-deficit hyperactivity disorder, eating disorders, personality disorder, substance use disorder, post-traumatic stress disorder, panic disorder, or social phobia), but anxiety disorders as comorbid conditions are acceptable; 3.Currently using drugs that may significantly affect cortical excitability (e.g., benzodiazepines, antiepileptic drugs, etc.); 4.Previous suicide attempt or significant suicidal ideation within 4 weeks prior to baseline (defined as a score of =3 on item 3 of the baseline HDRS-17 scale); 5.Depressive symptoms can be better explained by other clinical conditions (e.g. hypothyroidism, anemia, congestive heart failure) or other mental disorders; 6.Patients with severe and unstable cardiovascular diseases, liver diseases, kidney diseases, hematologic diseases, endocrine disorders, malignant tumors, or other somatic diseases; 7.Laboratory tests reveal significant hepatic or renal impairment, or other severe systemic diseases and metabolic disorders, including screening or baseline total bilirubin (TBIL) levels exceeding 1.5 times the upper limit of normal, or alanine aminotransferase (ALT) or aspartate aminotransferase (AST) levels exceeding 3 times the upper limit of normal, or glomerular filtration rate (GFR) =70 mL/min, or thyroid-stimulating hormone (TSH) levels outside the normal range. 8.Hypertensive subjects with poor blood pressure control (screening or baseline sitting systolic blood pressure (SBP) =140mmHg or sitting diastolic blood pressure (DBP) =90 mmHg); 9.Epilepsy and/or other neurological disorders (such as stroke, dementia, traumatic brain injury, Parkinson's disease, Huntington's disease, multiple sclerosis), as well as any neurological conditions that lead to increased intracranial pressure, brain damage, or elevated risk of epileptic seizures; 10.Pregnancy,lactation or planned pregnancy; 11.Have visual or hearing impairment and cannot be assessed by intervention or questionnaire; 12.Received brain stimulation therapy (such as electroconvulsive therapy(ECT), modified electroconvulsive therapy (mECT), transcranial magnetic stimulation (TMS),repetitive transcranial magnetic stimulation(rTMS),deep brain stimulation,vagus nerve stimulation,etc.)within 3 months prior to baseline; 13.Received light therapy within 2 weeks prior to baseline; 14.Participated in other clinical trials within 1 month prior to baseline(except for unqualified screening and not enrolled); 15.Other circumstances in which the subject is judged by the investigator to be unsuitable for participation in the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Changes in HDRS-17 Scores Across Time Points; | — |
Secondary
| Measure | Time frame |
|---|---|
| Mindfulness Skills;Assess the overall disease severity of patients at each time point and the temporal changes in treatment efficacy.;Rumination;Sleep Quality;Treatment-emergent manic or hypomanic symptoms;Changes in Depression and Anxiety Symptoms Over Time;Degree of Functional Impairment in Major Life Domains;Adverse events related to tDCS and adverse events related to VR; | — |
Countries
China
Contacts
Public ContactWanjun Guo
Hangzhou Seventh People's Hospital
Outcome results
None listed