Efficacy and Safety of Sertraline Combined With Lactobacillus Crispatus in Adolescents With Depression

Efficacy and Safety of Sertraline Combined With Lactobacillus Crispatus in Adolescents With Depression : A Multicenter Randomized Controlled Trial

The goal of this clinical trial is to evaluate the efficacy and safety of sertraline combined with Lactobacillus crispatus in adolescents aged 12-18 years with major depressive disorder. The main question it aims to answer is: Whether sertraline combined with Lactobacillus crispatus is superior to sertraline combined with placebo in reducing depressive symptoms and improving emotional symptoms in adolescents with depression.

If there is a comparison group: Researchers will compare sertraline combined with Lactobacillus crispatus with sertraline combined with placebo ( look-alike substance that contains no probiotics) to determine whether the addition of Lactobacillus crispatus provides greater therapeutic benefit in adolescents with depression.

Participants will: 1. Receive sertraline combined with Lactobacillus crispatus or sertraline combined with placebo for 8 weeks; 2. Attend clinic visits every 4 weeks for clinical assessments and safety monitoring

Inclusion criteria

• 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

Exclusion criteria

• 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
• Pregnancy or breastfeeding