Depression
Conditions
Interventions
Intervention Group:Exosomes administered via nasal drops once daily for 12 consecutive days
Control Group:Placebo administered via nasal drops once daily for 12 consecutive days
Sponsors
Beijing Anding Hospital, Capital Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: 1. Age: 18 - 65 years old, gender not restricted; 2. Meets the diagnostic criteria for recurrent major depressive disorder as defined in the Fifth Edition of the Diagnostic and Statistical Manual of Mental Disorders (DSM-5), and this episode does not involve psychotic symptoms; 3. At the screening baseline, the MADRS score was >= 22; 4. At least 14 days prior to this episode, the patient had not been receiving antidepressant medication treatment (patients taking fluoxetine should discontinue it for at least 28 days) or was willing to undergo drug detoxification; 5. In the past 3 months, the patient has not received traditional Chinese medicine treatment for mental disorders, systematic psychological therapy, or physical therapy such as TMS; 6. Has a high school education or above, and can understand the content of the scale; 7. The patient has given informed consent and voluntarily signed a written informed consent form.
Exclusion criteria
Exclusion criteria: 1. Consistent with other mental disorder diagnoses in DSM-5; 2. Refractory depressive disorder; 3. Suffering from severe or unstable physical diseases, or those that may affect the safety of the trial and are evaluated by the investigator to be unsuitable for participation by the subject; 4. Within the past 1 month, the intensity level of the suicide ideation module of the Columbia Suicide Severity Rating Scale (C-SSRS) reached 4 or above, or the 10th suicide item of the MADRS was >= 4 points, or the investigator judged that there was a risk of suicide; 5. Severe nasal diseases or history of nasal surgery that prevent the use of nasal droplet administration; 6. Those who experience fainting or hemophobia or cannot tolerate venous blood collection; 7. Those with contraindications for magnetic resonance scanning; 8. Pregnant or lactating women, or patients who cannot take appropriate contraceptive measures during the trial; 9. Other situations that the investigator deems unsuitable for participation in this clinical study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Montgomery-?sberg Depression Scale score; | — |
Secondary
| Measure | Time frame |
|---|---|
| Hamilton Depression Scale score;Hamilton Anxiety Scale score;Young's Mania Rating Scale score;Nine-item Patient Health Questionnaire;Score of the Generalized Anxiety Disorder Scale;Cognitive Function Deficit Self-Assessment Questionnaire;Pittsburgh Sleep Quality Index Scale;Colombia Suicide Severity Rating Scale;Sheehan Disability Scale;Strue word test;Trail making test;Functional Connectivity;Inflammatory Factor; | — |
Countries
China
Contacts
Public ContactGang Wang
Beijing Anding Hospital, Capital Medical University
Outcome results
None listed