Clinical Trial

Sertraline Combined With Multi-Strain Probiotics for Adolescent Depression

Recruiting Phase 2
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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.
Trial Details
NCT Number NCT07645157
Lead Sponsor First Affiliated Hospital of Chongqing Medical University
Conditions Major Depressive Disorder (MDD), Probiotic Intervention
Enrollment 120 participants
Start Date 2026-10-01
Primary Completion 2028-10-01 (estimated)
Study Completion 2028-10-01 (estimated)
Updated on ClinicalTrials.gov 2026-06-12