Sertraline Combined With Multi-Strain Probiotics for Adolescent Depression

NCT07645157 · tracked via the Priya Life Science China tracker

Sponsor

First Affiliated Hospital of Chongqing Medical University

Phase

Phase 2

Started

2026-10-01

Last updated

2026-06-12

Condition(s) studied

Major Depressive Disorder (MDD)Probiotic Intervention

Investigational drug(s) / intervention(s)

Sertraline →

Sertraline: Weeks 1-4, the starting dose of sertraline is 25 mg/day, adjusted according to the clinical assessment of the psychiatrist, with a dosage range of 25-150 mg/day. By week 4, the sertraline dosage should reach at least 150 mg/day; placebo powder, 1 sachet/day.

Study summary

The objective of this clinical trial is to evaluate the efficacy and safety of sertraline combined with multi-strain probiotics in adolescents aged 12-18 with major depressive disorder. The primary research question is whether sertraline combined with multi-strain probiotics is superior to sertraline combined with placebo in alleviating depressive symptoms and improving mood symptoms in adolescents. If there is a control group: researchers will compare sertraline combined with multi-strain probiotics with sertraline combined with placebo (a substance that looks similar but does not contain probiotics) to determine whether adding multi-strain probiotics provides greater therapeutic benefits for adolescent patients with depression. Participants will: 1. Undergo 8 weeks of treatment with sertraline combined with multi-strain probiotics or sertraline combined with placebo; 2. Have clinical visits every 4 weeks for clinical assessments and safety monitoring.

Eligibility

Sex

ALL

Min age

12 Years

Max age

18 Years

Healthy volunteers

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

Primary outcome measure(s)

Change in Children's Depression Rating Scale - Revised (CDRS-R) scores — Assessments will be performed at baseline, week 4, and week 8
The Children's Depression Rating Scale-Revised (CDRS-R) is a semi-structured clinician-rated interview designed to assess the severity of depressive symptoms in children and adolescents. The total score ranges from 17 to 113, with higher scores indicating more severe depressive symptoms.

Trial sites (1)

Facility	City	Region	Status
The Affiliated Hospital of Chongqing Medical University	Chongqing	Yuzhong	Recruiting

On this site

📄 Zoloft (sertraline) drug profile →

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07645157 on ClinicalTrials.gov ↗ ← All trials in China