RecruitingPhase 2

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

China60 participantsStarted 2026-06-11

Plain-language 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

Who can participate

Age range

12 Years – 18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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 crispatu…

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1This trial combines sertraline with a specific probiotic called Lactobacillus crispatus — how does my doctor feel about the current evidence for using probiotics alongside antidepressants in teenagers, and is this combination something worth considering for my child's situation?
2Since this is a Phase 2 trial and it hasn't started recruiting yet, what does that mean for how much is already known about the safety and effectiveness of this particular combination in adolescents?
3The trial measures depression improvement using a scale called the CDRS-R — can my doctor explain what a meaningful change on that scale would look like in practice, and how that compares to what we'd expect from standard sertraline treatment alone?
4Because this trial isn't recruiting yet, would it make more sense to start with an established treatment now rather than waiting, and how would my doctor weigh those two paths given my child's current severity of symptoms?
5Are there any known risks or interactions between sertraline and Lactobacillus crispatus that my doctor would want to monitor closely if this trial eventually becomes available and we consider enrolling?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

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

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

Trial details

NCT IDNCT07539805

SponsorFirst Affiliated Hospital of Chongqing Medical University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2028-02

Contact for this trial

Teng Teng

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

View on ClinicalTrials.gov More Major Depressive Disorder (MDD) trials