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

NCT07539805 | Not Yet Recruiting Phase 2

• 1 other identifier: zz2025-535-03
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

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

Outcome Measures

Primary Outcomes (1)

• Change in Children's Depression Rating Scale - Revised (CDRS-R) scores

  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.

  Assessments will be performed at baseline, week 4, and week 8

Secondary Outcomes (14)

• Change in Baker Depression Scale（BDI） scores from baseline

  Assessments will be performed at baseline, week 4, and week 8

• Change in the Screen for Child Anxiety-Related Emotional Disorders（SCARED）scores from baseline

  Assessments will be performed at baseline, week 4, and week 8

• Change in Hamilton Anxiety Scale (HAMA）scores from baseline

  Assessments will be performed at baseline, week 4, and week 8

• Change in suicide risk on the Columbia Suicide Severity Rating Scale (C-SSRS ) scores from baseline

  Assessments will be performed at baseline, week 4, and week 8

• Change in Young Mania Rating Scale (YMRS) scores from baseline

  Assessments will be performed at baseline, week 4, and week 8

Study Arms (2)

Sertraline combined with Lactobacillus crispatus group

EXPERIMENTAL

Combination Product: Sertraline combined with Lactobacillus crispatus

Sertraline combined with placebo group

ACTIVE COMPARATOR

Combination Product: Sertraline combined with placebo

Interventions

Sertraline combined with Lactobacillus crispatus COMBINATION_PRODUCT

Phase 1 (Weeks 1-4): Sertraline will be initiated at 25 mg/day and titrated according to clinical judgment, with a permissible dose range of 25-150 mg/day. By Week 4, the sertraline dose will reach a minimum of 150 mg/day. Concomitantly, Lactobacillus crispatus powder will be administered at 1 sachet/day (1×10⁹ CFU/sachet). Phase 2 (Weeks 5-8): Sertraline will be maintained at 150-200 mg/day, with dose adjustments guided by the psychiatrist's clinical judgment. Lactobacillus crispatus powder will remain at 1 sachet/day (1×10⁹ CFU/sachet).

Sertraline combined with Lactobacillus crispatus group

Sertraline combined with placebo COMBINATION_PRODUCT

Phase 1 (Weeks 1-4): Sertraline will be initiated at 25 mg/day based on the psychiatrist's clinical assessment, with a permissible dose range of 25-150 mg/day. By Week 4, the sertraline dose will attain at least 150 mg/day, with concomitant placebo powder at 1 sachet/day. Phase 2 (Weeks 5-8): Sertraline will be maintained at 150-200 mg/day, with dose adjustments guided by the psychiatrist's clinical assessment. Placebo powder will be maintained at 1 sachet/day.

Sertraline combined with placebo group

Eligibility Criteria

• Age: 12 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• First Affiliated Hospital of Chongqing Medical University: lead

Study Sites (1)

The Affiliated Hospital of Chongqing Medical University

Chongqing, Yuzhong, 400010, China

Location

MeSH Terms

Conditions

Depressive Disorder, Major

Condition Hierarchy (Ancestors)

Depressive Disorder; Mood Disorders; Mental Disorders

Central Study Contacts

Teng Teng

CONTACT

+86 18883368354; tengteng@hospital.cqmu.edu.cn

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research Associate

Study Record Dates

• First Submitted: April 14, 2026
• First Posted: April 20, 2026
• Study Start: May 1, 2026
• Primary Completion (Estimated): February 1, 2028
• Study Completion (Estimated): April 1, 2028
• Last Updated: May 4, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)