NCT07645157 Sertraline Combined With Multi-Strain Probiotics for Adolescent Depression
| NCT ID | NCT07645157 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | First Affiliated Hospital of Chongqing Medical University |
| Condition | Major Depressive Disorder (MDD) |
| Study Type | INTERVENTIONAL |
| Enrollment | 120 participants |
| Start Date | 2026-10-01 |
| Primary Completion | 2028-10-01 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 120 participants in total. It began in 2026-10-01 with a primary completion date of 2028-10-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
The objective of this clinical trial is to evaluate the efficacy and safety of sertraline combined with multi-strain probiotics in adolescents aged 12-18 with major depressive disorder. The primary research question is whether sertraline combined with multi-strain probiotics is superior to sertraline combined with placebo in alleviating depressive symptoms and improving mood symptoms in adolescents. If there is a control group: researchers will compare sertraline combined with multi-strain probiotics with sertraline combined with placebo (a substance that looks similar but does not contain probiotics) to determine whether adding multi-strain probiotics provides greater therapeutic benefits for adolescent patients with depression. Participants will: 1. Undergo 8 weeks of treatment with sertraline combined with multi-strain probiotics or sertraline combined with placebo; 2. Have clinical visits every 4 weeks for clinical assessments and safety monitoring.
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
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07645157 clinical trial?
This trial is open to participants of all sexes, aged 12 Years or older, up to 18 Years, studying Major Depressive Disorder (MDD). Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07645157 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT07645157 currently recruiting?
Yes, NCT07645157 is actively recruiting participants. Contact the research team at tengteng@hospital.cqmu.edu.cn for enrollment information.
Where is the NCT07645157 trial being conducted?
This trial is being conducted at Chongqing, China.
Who is sponsoring the NCT07645157 clinical trial?
NCT07645157 is sponsored by First Affiliated Hospital of Chongqing Medical University. The trial plans to enroll 120 participants.