Major depressive disorder
Conditions
Interventions
CLAS group:Simultaneously with sleep EEG monitoring, 2-week CLAS intervention during sleep will be conducted
Sham group:Only conducting 2-week sleep EEG monitoring without intervention of CLAS during sleep
Sponsors
Hangzhou Seventh People's Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 50 Years
Inclusion criteria
Inclusion criteria: (1) Outpatient or inpatient patients aged 18-50 (including 18 and 50 years old), regardless of gender; (2) Right-handed, primary school education or above; (3) Meets the diagnostic criteria for major depressive disorder episodes in DSM-5, single episode or recurrent episode; (4) Hamilton Depression Rating Scale (HAMD-24) score >= 20 points; (5) Pittsburgh Sleep Quality Index (PSQI) score >= 5; (6) No antidepressant drugs were used or the current antidepressant treatment plan was stably used for at least 4 weeks; (7) Understand and voluntarily participate in this study, be able to follow the treatment process, and sign an informed consent form.
Exclusion criteria
Exclusion criteria: (1) Meet the diagnostic criteria for other mental disorders in DSM-5, such as post-traumatic stress disorder, neurocognitive disorders, schizophrenia, bipolar disorder, alcohol (or drug) dependence or abuse, personality disorders, etc; (2) Depressive episodes secondary to a systemic or neurological disorder; (3) Serious physical illnesses, such as heart, liver, and kidney dysfunction, impaired respiratory function, severe infections, etc; (4) Any serious neurological disease or damage, including but not limited to space occupying brain injury, history of epileptic seizures, Parkinson's disease, multiple sclerosis, severe head trauma; (5) Implanting electronic devices such as pacemakers and cochlear implants into the body; (6) Pregnant or lactating patients; (7) Received other neuroregulatory treatments such as MECT or rTMS within the past 3 months; (8) Individuals with autoimmune diseases such as systemic lupus erythematosus and rheumatoid arthritis, or with upper respiratory tract infections or other infectious diseases within 2 weeks prior to enrollment; (9) HAMD-24 score >= 3 in item 3, or those who currently or in the past 12 months have a clear tendency towards suicide, and are considered at risk of suicide and violent behavior based on the researcher's clinical assessment.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Sleep architecture;Inflammatory indicators;Depressive degree; | — |
Secondary
| Measure | Time frame |
|---|---|
| Anxiety degree;Depressive symptoms;Anxiety symptoms;Suicidal ideation;Clinical symptoms;Sleep quality;Sleep rhythm;Brain function;Heart rate variability;Cognitive function;Sex hormone; | — |
Countries
China
Contacts
Public ContactDeng Wei
Hangzhou Seventh People's Hospital
Outcome results
None listed