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

StatusRecruiting
PhasePhase 2
Started
View on ClinicalTrials.gov ↗

Record History

  1. Recruitment opened Start date changed from estimate of May 2026 to Jun 11, 2026 · Site details revised at 2 of 2 sitesv4 Show 2 more changesShow less
    • Start date changed from estimate of May 2026 to Jun 11, 2026
    • Site details revised at 2 of 2 sites
  2. Study sites: 1 to 2v3
  3. Start date: Apr 2026 to May 2026 Eligibility criteria shortened, about 14 words · Secondary endpoints: 13 to 14 · Study title shortened, about 6 wordsv2 Show 3 more changesShow less
    • Eligibility criteria shortened, about 14 words
    • Secondary endpoints: 13 to 14
    • Study title shortened, about 6 words

    See this version in full on ClinicalTrials.gov ↗

  4. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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
Trial Details
NCT Number NCT07539805
Lead Sponsor First Affiliated Hospital of Chongqing Medical University
Conditions Major Depressive Disorder (MDD), Probiotic Intervention
Enrollment 60 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov