Sertraline plus a probiotic for teenagers with depression
Tests adding Lactobacillus crispatus to sertraline in teenagers with major depressive disorder.
Plain-language title generated from the registry record
Registry title: Efficacy and Safety of Sertraline Combined With Lactobacillus Crispatus in Adolescents With Depression
Key facts
- Where
- Chongqing and Longgang, ChinaSee the 2 sites
- Phase
- Phase 2
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 12 and 18 years old?
Source: NCT07539805, who can take part
Where in China
- The Affiliated Hospital of Chongqing Medical UniversityChongqing, ChinaTaking people
- The Affiliated Dazu's Hospital of Chongqing Medical UniversityLonggang, ChinaNot yet recruiting
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- First Affiliated Hospital of Chongqing Medical University
- Trial code
- NCT07539805
- Record updated
- 15 June 2026
- Original description
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.Read full original descriptionShow less
Efficacy and Safety of Sertraline Combined With Lactobacillus Crispatus in Adolescents With Depression : A Multicenter Randomized Controlled Trial
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
Inclusion: 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: Use of probiotic-related food or medicine within 2 weeks before enrollment; Systemic use of antibiotics or antifungals within 1 month before enrollment; Presence of any comorbid psychiatric disorder according to DSM-5, other than anxiety disorders; 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); History of intolerance to sertraline or nonresponse to an adequate therapeutic course of sertraline; History of alcohol or drug abuse or dependence; History of severe food allergy or known hypersensitivity to the Lactobacillus crispatus preparation or any of its components; MDD with psychotic symptoms; Young Mania Rating Scale (YMRS) >13 at baseline; Nonresponse to at least two antidepressants with different mechanisms, and each administered at an adequate dose and for an adequate duration; Current high suicide risk; Taking or administering antidepressants within 5 half-lives; Adherence to vegetarian or other restrictive dietary patterns; Pregnancy or breastfeeding.