Sertraline plus a probiotic (Lactobacillus crispatus) for teens with depression

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

The trial enrolls adolescents aged 12–18 with major depressive disorder who receive sertraline and are randomized to also receive either Lactobacillus crispatus or a placebo for 8 weeks. Participants visit the clinic every 4 weeks for safety checks and symptom assessments. The goal is to see if the probiotic combination provides greater improvement in mood and emotional symptoms than sertraline with placebo. The study excludes individuals with certain comorbid psychiatric or neurological conditions and those with inadequate antidepressant response history. The lead sponsor is the First Affiliated Hospital of Chongqing Medical University, with sites in Chongqing, China.

Why it matters

Who can join: the full rules

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

Where it's running

• The Affiliated Hospital of Chongqing Medical University
  Chongqing, Yuzhong, China Recruiting
• The Affiliated Dazu's Hospital of Chongqing Medical University
  Longgang, Chongqing Municipality, China Not yet recruiting

Study contacts

• Study coordinator: Teng Teng
• Email: tengteng@hospital.cqmu.edu.cn
• Phone: +86 18883368354

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.