Sertraline Combined With Multi-Strain Probiotics for Adolescent Depression

Sponsor
First Affiliated Hospital of Chongqing Medical University
Study ID
NCT07645157
Phase
PHASE2
Status
Recruiting
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Conditions

  • Major Depressive Disorder (MDD)
  • Probiotic Intervention

Eligibility Criteria

Sex
ALL
Age
12 Years - 18 Years
Healthy Volunteers
Not accepted

Interventions

  • Sertraline — DRUG
    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 Details

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.

Key Dates

First listed
Jun 12, 2026
Start date
Oct 1, 2026
Status verified
Jun 2026
Primary completion
Oct 1, 2028
Completion
Oct 1, 2028

Study Design

Enrollment
120 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Sertraline combined with compound probiotics group
    Phase 1: 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; compound probiotic powder, 1 sachet/day. Phase 2: Weeks 5-8, the sertraline dosage is 150-200 mg/day, adjusted according to the clinical assessment of the psychiatrist; compound probiotic powder, 1 sachet/day.
  • Experimental: Sertraline combined with placebo group
    Phase 1: 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. Phase 2: Weeks 5-8, the sertraline dosage is 150-200 mg/day, adjusted according to the clinical assessment of the psychiatrist; placebo powder, 1 sachet/day.

Primary Outcome Measure

Change in Children's Depression Rating Scale - Revised (CDRS-R) scores [ Time Frame: Assessments will be performed at baseline, week 4, and week 8 ]

Central Contacts

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