First Affiliated Hospital of Chongqing Medical University
Age
12–18
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
Aged 12-18 years
Meets DSM-5 criteria for major depressive disorder (MDD) and is currently in a depressive episode according to the Kiddie Schedule for Affective Disorders and Schizophrenia - Present and Lifetime Version (K-SADS-PL) interviews
Child Depression Rating Scale-Revised (CDRS-R) score ≥40 at baseline
Clinical Global Impression Scale (CGI-S) score ≥ 4 at baseline
You may not be if
Presence of any comorbid psychiatric disorder according to DSM-5, other than anxiety disorders
MDD with psychotic symptoms
Young Mania Rating Scale (YMRS) \>13 at baseline
History of neurological disorders (e.g., epilepsy, traumatic brain injury), or the presence of serious physical illnesses (e.g., thyroid disease, lupus erythematosus, diabetes mellitus, clinically significant pulmonary, hepatic, or renal impairment, or major trauma)
Nonresponse to at least two antidepressants with different mechanisms, and each administered at an adequate dose and for an adequate duration
History of intolerance to sertraline or nonresponse to an adequate therapeutic course of sertraline
Current high suicide risk
History of alcohol or drug abuse or dependence
Taking or administering antidepressants within 5 half-lives
Use of probiotic-related food or medicine within 2 weeks before enrollment
Systemic use of antibiotics or antifungals within 1 month before enrollment
History of severe food allergy or known hypersensitivity to the Lactobacillus crispatus preparation or any of its components
Adherence to vegetarian or other restrictive dietary patterns
