adolescent depression
Conditions
Interventions
Group A: LC-K11 polysaccharide group:From week 1 to week 6, take LC-K11 polysaccharide 250-500mg tablets/day (each tablet contains LC-K11 polysaccharide 250mg + 1-2 fluoxetine simulants)
Group B: Fluoxetine group:From the first to the sixth week, give fluoxetine 10-20 mg/day + LC-K11 polysaccharide simulation 1-2 tablets
Group C: Placebo group:From the first to the sixth week, patients were treated with 1-2 tablets of LC-K11 polysaccharide simulation and 1-2 tablets of fluoxetine simulation per day.
Sponsors
Children's Hospital of Soochow University
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Participants and their guardians voluntarily participate in this clinical study and sign the informed consent form before starting any study operations; 2. Male and female patients aged 12 years (including cut-offs) to under 18 years old, and weighing >=40kg; 3. Patients with depression with a current depressive episode duration of >=6 weeks at screening, who meet the diagnostic criteria of MDD in the Diagnostic and Statistical Manual of Mental Disorders, 5th edition (DSM-5), and confirmed by the children's version of the Concise International Neuropsychiatric Interview for Children and Adolescents (MINI-Kid); 4. Montgomery–Åsberg Depression Rating Scale (MADRS) score of >=22 points at screening and baseline; 5. Clinical Global Impressions Scale-Condition Severity (CGI-S) score >=4 points at screening and baseline; 6. Participants can understand and comply with the study requirements as judged by the investigator.
Exclusion criteria
Exclusion criteria: 1. Meet the DSM-5 diagnostic criteria for major depressive disorder with psychotic features. 2. Any history of, or current diagnosis of, any other medical condition other than DSM-5 major depressive disorder, including but not limited to bipolar and related disorders, schizophrenia, anxiety disorders, sleep-wake disorders, substance-related or addictive disorders, etc. 3. Any history of any of the following neurological conditions: epilepsy, multiple sclerosis, Huntington's disease, etc. 4. Any serious medical illness, including but not limited to neurological disease, cardiovascular disease, liver disease, kidney disease, blood disease, endocrine disease, etc. 5. Any history of malignancy (basal cell carcinoma of the skin) or leukemia, etc. 6. Patients with congenital or hereditary bleeding disorders (e.g., hemophilia, hereditary prothrombin deficiency), or a history of bleeding disorders (e.g., gastrointestinal bleeding, cerebral hemorrhage) within 1 year before the first dose, or planned gastrointestinal endoscopy during the trial, or other conditions that the investigator believes may increase the risk of bleeding at screening/baseline. 7. Patients with a history of angle-closure glaucoma. 8. Patients with suicidal behavior within 1 year before the first dose, or a MADRS item 10 (suicidal ideation) score >= 4 at screening or baseline. Treatment-Related Exclusion Criteria 9. Patients who have received fluoxetine within 4 weeks before the first dose; or those who have received antidepressants other than fluoxetine within 2 weeks before the first dose, including but not limited to tricyclic antidepressants, serotonergic drugs (e.g., SSRIs, SNRIs, vortioxetine), and monoamine oxidase inhibitors. 10. Receipt of any antipsychotic or psychoactive medication within 2 weeks prior to the first dose (sedatives and hypnotics within 1 week prior to the first dose). 11. Patients currently receiving systematic psychotherapy (interpersonal therapy, dynamic therapy, cognitive behavioral therapy, etc.), music therapy, exercise therapy, acupuncture, etc. at screening and/or baseline, and continuing to receive these treatments during the study. 12. Patients receiving depression-related physical therapy within 3 months prior to the first dose, including but not limited to modified electroconvulsive therapy (MECT), transcranial magnetic stimulation (TMS), vagus nerve stimulation (VNS), deep brain stimulation (DBS), light therapy, etc. 13. Patients who have previously responded to adequate and sufficient treatment with vortioxetine, or have previously responded to adequate and sufficient treatment with at least two antidepressants with different mechanisms of action. Medical Exclusion Criteria 14. Patients whose MADRS score at baseline decreased by >=25% compared to that at screening. 15. Alanine aminotransferase and/or aspartate aminotransferase >= 2 times the upper limit of normal, or total bilirubin and/or direct bilirubin >= 1.5 times the upper limit of normal, or serum creatinine >= 1.5 times the upper limit of normal, or thyroid-stimulating hormone (TSH) value outside the normal range during the screening period. 16. Positive urine drug abuse screen at baseline. 17. Clinically significant electrocardiogram abnormalities at screening or baseline. 18. Allergies to two or more drugs and/or foods, or a history of severe allergic reactions. 19. Hypersensitivity to any component of fluoxetine. 20. Pregnant or breastfeeding participants at screening or bas
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Montgomery-Asberg Depression Rating Scale; | — |
Secondary
| Measure | Time frame |
|---|---|
| Children's Depression Rating Scale–Revised;Clinical Global Impression-Severity Scale;Hamilton Anxiety Rating Scale;Perceived Deficits Questionnaire for Depression;Digit Symbol Substitution Test;Clinical Global Impression-Improvement Scale; | — |
Countries
China
Contacts
Public ContactWang Shikai
Children‘s Hospital of Soochow University
Outcome results
None listed