Sertraline Combined With Lactobacillus Crispatus in Adolescents With Depression Phase 2 Randomized Controlled Trial
Summary
The NIH National Library of Medicine has registered a Phase 2 multicenter randomized controlled trial (NCT07539805) evaluating sertraline combined with Lactobacillus crispatus versus sertraline combined with placebo in adolescents aged 12-18 with major depressive disorder. The 8-week trial includes clinical assessments and safety monitoring every 4 weeks. No compliance obligations or deadlines are imposed on external parties.
What changed
NIH registered a Phase 2 randomized controlled trial comparing sertraline combined with Lactobacillus crispatus to sertraline combined with placebo in adolescents aged 12-18 with major depressive disorder. The 8-week trial will assess therapeutic benefit and safety at clinic visits every 4 weeks.
This is an informational clinical trial registration that does not impose compliance obligations on any external parties. Pharmaceutical companies, clinical investigators, and adolescent psychiatry researchers conducting similar studies should monitor this trial for emerging data on probiotic-augmented antidepressant approaches.
Archived snapshot
Apr 20, 2026GovPing captured this document from the original source. If the source has since changed or been removed, this is the text as it existed at that time.
Efficacy and Safety of Sertraline Combined With Lactobacillus Crispatus in Adolescents With Depression : A Multicenter Randomized Controlled Trial
Phase 2 NCT07539805 Kind: PHASE2 Apr 20, 2026
Abstract
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
Conditions: Major Depressive Disorder (MDD), Probiotic Intervention
Interventions: Sertraline combined with Lactobacillus crispatus, Sertraline combined with placebo
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