Depressive Disorders
Conditions
Interventions
Intervention group:Take 6 capsules of CreNeuroSTM CNS Fish Oil Plus Softgels daily (1 capsule: 765mg), 3 capsules each time, twice a day, once in the morning and once in the evening, after meals, for
Sponsors
Sichuan Academy of Medical Sciences & Sichuan Provincial People's Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: Participants meeting all of the following criteria are eligible for this clinical study: 1.Aged 18 to 65 years old (inclusive), of any gender; 2. Meeting the diagnostic criteria for a depressive episode as specified in the Diagnostic and Statistical Manual of Mental Disorders (5th Edition) (DSM-5); 3. A total score of 8 or above and below 24 on the 17-item Hamilton Depression Rating Scale (HAMD-17); 4. A total score of 17 or below on the Hamilton Anxiety Rating Scale (HAMA); 5. A score of 3 or above on the Clinical Global Impression-Severity Scale (CGI-S); 6. Having the ability to understand the study, voluntarily participating in it, and signing the informed consent form (ICF).
Exclusion criteria
Exclusion criteria: Individuals with any of the following conditions are not eligible for inclusion in this clinical study: 1.Comorbid with other psychiatric disorders (e.g., schizophrenia, bipolar disorder, other psychotic disorders, etc.); 2. Patients judged by the investigator to have suicidal tendencies; 3. A history of substance abuse within 6 months prior to screening; 4. Patients planning to take or currently taking drugs prohibited by the study protocol; 5. A history of electroconvulsive therapy (ECT), transcranial magnetic stimulation (TMS) or vagus nerve stimulation (VNS) within 6 months prior to screening, or deep brain stimulation (DBS) received during the current depressive episode; 6. Newly initiated psychotherapy or changes in the intensity of ongoing psychotherapy within 8 weeks prior to screening; 7. Patients with current or past history of neurological, cardiovascular, respiratory, digestive, renal, hepatic, hematological, endocrine or other medical diseases, which the investigator determines may compromise the safety of study participation, interfere with the conduct of the study, or affect the interpretation of study results; 8. Participation in other non-interventional studies within 3 months or at present, or any interventional clinical studies involving investigational drugs, marketed drugs or medical devices; 9. Patients currently taking fish oil, n-3 PUFA supplements, folic acid or L-5-methyltetrahydrofolate; or patients with a known allergy to fish oil, folic acid/L-5-methyltetrahydrofolate, or non-dietary components of the study product; 10. Patients who consumed fish an average of no less than 3 times per week in the past month, or patients who took fish oil, n-3 PUFA supplements, folic acid or L-5-methyltetrahydrofolate within the past 6 months; 11. Pregnant patients, patients planning pregnancy, patients of childbearing potential who refuse to adopt effective contraceptive measures during the study and for 3 months after the last administration, or lactating patients; 12. Patients judged by the investigator to be ineligible for participation in this study for other reasons.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The Hamilton Depression Rating Scale (HAMD-17) was used to assess the changes in depressive symptoms of the participants before and after the intervention.; | — |
Secondary
| Measure | Time frame |
|---|---|
| Change from baseline in Hamilton Anxiety Rating Scale (HAMA) score at each visit;Change from baseline in Clinical Global Impression - Improvement (CGI-I) and Severity (CGI-S) scores at each visit;Change from baseline in Self-Rating Depression Scale (SDS) score at each visit;Change in stress coping ability assessed by the Coping Style Questionnaire (CSQ) in subjects before and after using CreNeuroSTM CNS Fish Oil Plus Softgels;Change in quality of life assessed by the EuroQol 5-Dimension 5-Level (EQ-5D-5L) scale in subjects before and after using CreNeuroSTM CNS Fish Oil Plus Softgels;Subject satisfaction with CreNeuroSTM CNS Fish Oil Plus Softgels in terms of taste, convenience, and perceived benefit, assessed by a self-designed satisfaction questionnaire;Time to first perceived mood improvement and optimal effect time window with CreNeuroSTM CNS Fish Oil Plus Softgels;Concomitant medication use with CreNeuroSTM CNS Fish Oil Plus Softgels and analysis of its impact on mood improvement; | — |
Countries
China
Contacts
Public ContactZhou Bo
Sichuan Academy of Medical Sciences & Sichuan Provincial People's Hospital
Outcome results
None listed