NCT07539805RecruitingPhase 2
Efficacy and Safety of Sertraline Combined With Lactobacillus Crispatus in Adolescents With Depression
Efficacy and Safety of Sertraline Combined With Lactobacillus Crispatus in Adolescents With Depression : A Multicenter Randomized Controlled Trial
Source: ClinicalTrials.gov · Last updated 15 Jun 2026
Brief summary (registry, in English)
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
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 60 (estimated)
- First submitted
- 14 Apr 2026
- Start date
- 11 Jun 2026
- Primary completion date
- Feb 2028
- Lead sponsor
- First Affiliated Hospital of Chongqing Medical University
- Diseases
- Depression
- NCT number
- NCT07539805
What you commit to
- Study type: Interventional · Phase 2
- Planned participants: 60
- From 11 Jun 2026 to the primary completion date, Feb 2028
- 2 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Use of probiotic-related food or medicine within 2 weeks before enrollment
- Systemic use of antibiotics or antifungals within 1 month before enrollment
Other illness
- 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
Other
- 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
Who the study is looking for
- 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
Age in the registry: 12 years to 18 years · Sex: All · Does not accept healthy volunteers
Sites (2)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| The Affiliated Hospital of Chongqing Medical University Coordinator of this site? Confirm its status | Chongqing | China | Recruiting |
| The Affiliated Dazu's Hospital of Chongqing Medical University Coordinator of this site? Confirm its status | Longgang | China | Not yet recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.