Depression
Conditions
Interventions
Experimental Group:Take 6 capsules of CreNeuroSTM CNS Fish Oil Plus Softgels daily (approximately 790mg per capsule), divided into 2 doses. Also take 1 capsule of fluoxetine hydrochloride placebo. Con
Control Group :Take 1 capsule of fluoxetine hydrochloride (20mg) daily, and 6 softgels of CreNeuroSTM CNS Fish Oil Plus Simulants (to be taken in 2 doses) continuously for 8 weeks. During the trial, t
Sponsors
Southwest Medical University Affiliated Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: 1. Age range: 18 - 65 years old (inclusive of the threshold value), gender not restricted; 2. Meets the diagnostic criteria for depressive episode as stipulated in the Diagnostic and Statistical Manual of Mental Disorders (5th Edition) (DSM-5); 3. Total score of HAMD17 >= 8 points and = 2 points; 5. CGI-S score >= 3 points; 6. Understand and voluntarily participate in this trial, and sign the informed consent form.
Exclusion criteria
Exclusion criteria: 1. Previously or currently diagnosed with: Schizophrenia, other psychotic disorders, Type I or Type II bipolar disorder; 2. Subjects currently receiving treatment or requiring treatment for post-traumatic stress disorder, acute stress disorder, panic disorder, or obsessive-compulsive disorder; 3. Those with anxiety disorders and an HAMA score of >= 21; 4. According to DSM-5 standards, currently diagnosed with delirium, borderline, antisocial, paranoid, schizotypal, schizoid, or expressive personality disorders; 5. Those with a history of antipsychotic drug toxic syndrome or 5-HT syndrome; 6. Subjects judged by the researcher to have suicidal tendencies; 7. Those who have had drug abuse within 6 months prior to screening; 8. Those who require treatment with prohibited drugs according to the protocol; 9. Those who have received electroconvulsive therapy, transcranial magnetic stimulation, or vagus nerve stimulation, or have received deep brain stimulation during the current depressive episode; 10. Those who have undergone new psychotherapy or a change in the intensity of psychotherapy within 8 weeks prior to screening; 11. Those currently or previously suffering from neurological, cardiovascular, respiratory, digestive, renal, liver, hematological, endocrine, or other medical diseases, as determined by the researcher or medical monitoring to affect the safety of the subjects participating in the study or affect the conduct of the study or interpretation of the study results, such as: Those with a history of epilepsy; Those with a history of severe heart disease, myocardial infarction, unstable angina pectoris, acute coronary syndrome or stroke, or a known personal or family history of cardiogenic sudden death; Those with atrial fibrillation who currently require anticoagulation treatment; Those with a history of asthma; Those with untreated acute/chronic gastric ulcers or Crohn's disease; Those with known liver or kidney dysfunction, or those whose laboratory test results at screening are judged by the researcher to have clinically significant indicators of liver or kidney function (such as ALT or AST > 2 times the upper limit of normal or creatinine exceeding 20% of the normal value); Those with laboratory tests showing hypothyroidism (TSH and T4); Those with a history of malignant tumors; 12. Those within 3 months or currently participating in other non-interventional studies, or any intervention-based research drugs, marketed drugs, or equipment clinical studies; 13. Those currently using fish oil or n-3 PUFAS supplements or folic acid or L-5-methyltetrahydrofolate, or allergic to fish oil, folic acid/L-5-methyltetrahydrofolate, or to the non-dietary components of the study food; 14. Those who ate fish >= 3 times per week in the past, or who have taken fish oil or n-3 PUFA supplements or folic acid or L-5-methyltetrahydrofolate in the past 6 months; 15. Those who are pregnant, planning to become pregnant, having reproductive capacity but unwilling to take effective contraceptive measures during the trial and within 3 months after the last medication intake; breastfeeding; 16. Those determined by the researcher to have other reasons that make them unsuitable to participate in this trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in total HAMD17 score from baseline after 8 weeks of double-blind treatment.; | — |
Secondary
| Measure | Time frame |
|---|---|
| Changes in total HAMD17 score from baseline at 2, 4, and 6 weeks after double-blind treatment;Response rate at 2, 4, 6, and 8 weeks after double-blind treatment (>= 50% reduction in total HAMD17 score from baseline);Remission rate at 2, 4, 6, and 8 weeks after double-blind treatment (total HAMD17 score <= 7);After 2 weeks, 4 weeks, 6 weeks, and 8 weeks of double-blind treatment, the changes in the Clinical Global Impression - Severity of Illness Scale (CGI-S) scores for depressive symptoms compared to the baseline were evaluated.;Proportion of patients with a Clinical Global Impressions-Improvement (CGI-I) score of 1 or 2 at 2, 4, 6, and 8 weeks after double-blind treatment.;Change in Self-rating Depression Scale (SDS) scores from baseline at 2, 4, 6, and 8 weeks after double-blind treatment.;Change in quality of life score (EQ-5D-5L) from baseline after 8 weeks of double-blind treatment.;Change in Hamilton Anxiety Rating Scale (HAMA) scores from baseline at 4 and 8 weeks after double-blind treatment.; | — |
Countries
China
Contacts
Public ContactKezhi Liu
Southwest Medical University Affiliated Hospital
Outcome results
None listed