Depressive Disorder
Conditions
Interventions
Intervention Group:Fecal Microbiota Transplantation (FMT) and Escitalopram Combination Therapy
Placebo Group:Placebo and Escitalopram
Sponsors
Peking University Sixth Hospital
Eligibility
Sex/Gender
All
Age
12 Years to 17 Years
Inclusion criteria
Inclusion criteria: 1 Patients who come to the outpatient department for treatment; 2 Aged 12 to 17 years old, male/female; 3 Meeting the diagnostic criteria of Major Depressive Disorder in DSM-5; 4 Diagnosed with MDD via the Kiddie-Schedule for Affective Disorders and Schizophrenia for School-Age Children - Present and Lifetime Version (K-SADS-PL DSM5-C), currently without significant suicidal risk or psychotic symptoms; 5 The score of HAMD-17 is >= 7 and <= 24; 6 Presence of gastrointestinal symptoms as assessed by the item 12 of the HAMD-17 or the item 11 of the HAMA at screening; 7 No antidepressant medication received within the last 3 months, and have a voluntary choice to be treated by Escitalopram during this visit; 8 No significant changes in dietary habits within the last 1 month, and a stable dietary routine can be maintained throughout the subsequent study period; 9 If now receiving non-pharmacological interventions (e.g., psychotherapy, cognitive-behavioral therapy, or rehabilitation therapy) or any medication for chronic physical conditions, any of these treatments must have been stable for at least 30 days at screening and then must be remained stable throughout the subsequent study period; 10 As judged by the investigator, the subject must be capable of participating and deemed suitable for the study, with a full understanding of the FMT (Fecal Microbiota Transplantation) treatment process and mechanism, and able to adhere to the study assessment schedule; 11 Parents or guardians are willing and able to provide written informed consent in accordance with local requirements. When the subject is capable of making the decision to participate, they must also be willing and able to provide written informed consent in accordance with local requirements.
Exclusion criteria
Exclusion criteria: 1.Being diagnosed with any mental disorder except neurodevelopmental disorders through the Kiddie-Schedule for Affective Disorders and Schizophrenia for School-Age Children - Present and Lifetime Version (K-SADS-PL DSM5-C); 2.Having received treatments prohibited by this study or any other experimental drug treatment within one month before screening; 3.Having significant changes in dietary habits or newly developed symptoms such as diarrhea and constipation (excluding chronic diarrhea or constipation) within one month before screening; 4.Having liver dysfunction (AST or ALT more than 2 times the upper limit of normal), renal dysfunction (serum creatinine more than 1.5 times the upper limit of normal), intestinal infection, active inflammatory bowel disease, or any other severe cardiac/hepatic/renal/respiratory/digestive/hematological and endocrine system diseases, as well as any comorbidities that may affect the ability to participate in the study at the time of screening; 5.Having gastrointestinal motility dysfunction (such as gastrointestinal obstruction, gastric paralysis, intestinal paralysis, etc.) or severe swallowing dysfunction at the time of screening; 6.Having any contraindications for taking intestinal bacteria capsules: a) Subjects with severe intestinal barrier damage accompanied by sepsis, active massive hemorrhage in the digestive tract, perforation, etc. due to various reasons; b) Currently diagnosed with fulminant colitis or toxic megacolon; c) Unable to tolerate 50% of caloric requirements for enteral nutrition due to severe diarrhea, significant fibrous stenosis of the intestinal lumen, severe gastrointestinal bleeding, high-flow intestinal fistula, etc.; d) Patients with innate or acquired immunodeficiency; e) Recently received high-risk immunosuppressive or cytotoxic drug treatment, such as rituximab, doxorubicin, or medium to high doses of steroid hormones (20mg/d prednisone or higher doses) for more than 4 weeks; f) Severe immunosuppression: neutrophils <1000/mm³; 7.Being allergic to polyethylene glycol, sulfur dioxide, sorbitol, escitalopram, or having any history of severe food or drug allergies; 8.Having a history of epilepsy, liver disease (such as cirrhosis, hepatic encephalopathy, esophageal and gastric varices, or portal shunt surgery, etc.), kidney disease (such as nephrotic syndrome or dialysis history, etc.), malignant tumor, or gastrointestinal resection surgery; 9.Being unable to communicate in Chinese, having impaired ability to understand the research content and provide written informed consent, being unwilling or unable to comply with the research requirements, having various factors affecting compliance or difficulty completing the trial, or having any other conditions that the researcher believes are not suitable for conducting the research.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Hamilton Depression Rating Scale-17, HAMD-17; | — |
Secondary
| Measure | Time frame |
|---|---|
| Hamilton Anxiety Rating Scale, HAMA;Patient Health Questionnaire-9, PHQ-9;Generalized Anxiety Disorder-7, GAD-7;Pittsburgh Sleep Quality Index, PSQI;Gastrointestinal Symptom Rating Scale, GSRS; | — |
Countries
China
Contacts
Public ContactCao qingjiu
Peking University Sixth Hospital
Outcome results
None listed