Sertraline with multi-strain probiotics for adolescents 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

In this phase 2 trial, adolescents with major depressive disorder will receive either sertraline plus multi-strain probiotics or sertraline plus placebo for 8 weeks, with clinical visits every four weeks for safety and symptom assessments. Participants must meet DSM-5 criteria for MDD and have moderate depressive symptoms at baseline. The study aims to determine if the probiotic addition provides additional benefit beyond sertraline alone. The primary endpoint is improvement in depressive symptoms compared to the control group, with safety monitoring throughout.

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

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.