Major Depressive Disorder
Conditions
Interventions
Experimental group:Depression light therapy lamp (illuminance: 5000~6500lux)
Control group:Comfort device phototherapy lamp (low-intensity dim red light treatment, illuminance: 100~180 lux)
Sponsors
Peking University Sixth Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 64 Years
Inclusion criteria
Inclusion criteria: 1. Meeting the diagnostic criteria for depression as specified in the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5), which may be a first episode or a recurrent episode; 2. Aged between 18 and 64 years (inclusive), regardless of sex; 3. Hamilton Depression Rating Scale (HAMD-17) score of 18 or greater; 4. Clinical Global Impressions Scale - Severity of Illness (CGI-S) score between 3 and 5; 5. For first-time patients, the duration of the current depressive episode must be 2 months or longer (counted as 30 days per month, same below); 6. Willing to participate in the study and sign an informed consent form.
Exclusion criteria
Exclusion criteria: 1. Diagnosis of any mental disorder other than depression (single episode and recurrent episode (296.2/296.3)) as defined by the DSM-5, including neurodevelopmental disorders, schizophrenia spectrum and other psychotic disorders, bipolar disorder, anxiety disorders, substance-related and addictive disorders, etc.; 2. Presence of severe somatic diseases or organic brain diseases (e.g., cerebral hemorrhage, large area cerebral infarction, encephalitis, epilepsy), or neurological diseases; 3. Patients with psychotic symptoms; 4. Previous or current depressive episodes that have not responded to adequate treatment with two different antidepressant medications; 5. Any degree of retinal disorders (including retinal dystrophy, age-related macular degeneration, diabetic retinopathy, etc.), cataracts, glaucoma, or other ocular diseases; 6. Presence of photosensitive diseases, such as systemic lupus erythematosus, porphyria, chronic actinic dermatitis, solar urticaria, etc.; 7. Failure to discontinue psychoactive medications for at least 5 half-lives prior to the baseline period; 8. Receipt of systematic psychotherapy (such as interpersonal therapy, psychodynamic therapy, cognitive behavioral therapy, etc.) or other physical treatments related to mental disorders (such as electroconvulsive therapy, modified electroconvulsive therapy, psychiatric acupuncture, transcranial magnetic stimulation, psychiatric laser treatment, vagus nerve stimulation, deep brain stimulation, and light therapy) within 3 months before screening; 9. History of suicide attempt within the past year or currently at high risk of suicide; or a score >=3 on item 3 (suicide) of the HAMD-17 during screening/baseline; 10. Substance abuse (including alcohol, drugs, and other psychoactive substances) within the past year before screening; 11. Women of childbearing potential with a positive pregnancy test result during the screening period, currently pregnant or breastfeeding, or planning to conceive within the next 3 months; 12. Patients taking medications that may increase photosensitivity; 13. Any other reasons deemed inappropriate by the researchers for participation in this clinical trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Efficacy after 2 weeks of treatment; | — |
Secondary
| Measure | Time frame |
|---|---|
| The remission rate of HAMD-17 total score at the end of 1 week and 2 weeks of treatment;the change in HAMD-17 total score from baseline at the end of 1 week and 2 weeks of treatment;the change in CGI-S total score from baseline at the end of 1 week and 2 weeks of treatment;CGI-I scores at the end of 1 week and 2 weeks of treatment; the change in HAMA total score from baseline at the end of 1 week and 2 weeks of treatment;Adverse event;Vital signs (record body temperature, heart rate, blood pressure, respiration, height, and weight after 10 minutes of rest);Vision impairment condition;The number of occurrences and incidence rate of device defects (DD); | — |
Countries
China
Contacts
Public ContactDong Wentian
Peking University Sixth Hospital
Outcome results
None listed