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

Official title

Efficacy and Safety of Sertraline Combined With Lactobacillus Crispatus in Adolescents With Depression : A Multicenter Randomized Controlled Trial

Overview

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

Interventions

• Combination product Sertraline combined with Lactobacillus crispatus
  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 wi
• Combination product Sertraline combined with placebo
  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.

Primary outcome measures

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

Secondary outcome measures (12)

• Change in Baker Depression Scale（BDI） scores from baseline [Time frame: 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 [Time frame: Assessments will be performed at baseline, week 4, and week 8]
• Change in Hamilton Anxiety Scale (HAMA）scores from baseline [Time frame: 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 [Time frame: Assessments will be performed at baseline, week 4, and week 8]
• Change in Young Mania Rating Scale (YMRS) scores from baseline [Time frame: Assessments will be performed at baseline, week 4, and week 8]
• Changes in Ruminative Response Scale (RRS) scores from baseline [Time frame: Assessments will be performed at baseline, week 4, and week 8]
• Medication adherence [Time frame: Assessments will be performed at week 4, and week 8]
• Changes in Connor-Davidson Resilience Scale (CD-RISC) scores from baseline [Time frame: Assessments will be performed at baseline, week 4, and week 8]
• Changes in Pediatric Quality of Life Inventory™ Version 4.0 Scale (PedsQL™) scores from baseline [Time frame: Assessments will be performed at baseline, week 4, and week 8]
• Change in Pittsburgh Sleep Quality Index (PSQI) scores from baseline [Time frame: Assessments will be performed at baseline, Week 4, and Week 8]
• Changes in Gastrointestinal Symptom Rating Scale (GSRS) scores from baseline [Time frame: Changes from baseline to week 4 and week 8]
• Changes in Childhood Trauma Questionnaire (CTQ) scores from baseline [Time frame: Assessments will be performed at baseline, week 4, and week 8]

Eligibility criteria

Inclusion criteria

• 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

Exclusion criteria

• 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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Quadruple blind

Primary purpose

Treatment

Study locations

China · 2 centers

• The Affiliated Dazu's Hospital of Chongqing Medical University — Longgang
• The Affiliated Hospital of Chongqing Medical University — Chongqing

Identifiers

NCT: NCT07539805 · zz2025-535-03

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗