Sertraline Combined With Multi-Strain Probiotics for Adolescent Depression

NCT07645157 | Recruiting Phase 2

• 1 other identifier: ZZ2025-940-02
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

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.

Conditions

Major Depressive Disorder (MDD); Probiotic Intervention

Outcome Measures

Primary Outcomes (1)

• Change in Children's Depression Rating Scale - Revised (CDRS-R) scores

  The Children's Depression Rating Scale-Revised (CDRS-R) is a semi-structured clinician-rated interview designed to assess the severity of depressive symptoms in children and adolescents. The total score ranges from 17 to 113, with higher scores indicating more severe depressive symptoms.

  Assessments will be performed at baseline, week 4, and week 8

Secondary Outcomes (1)

• Change in Baker Depression Scale#BDI# scores from baseline

  Assessments will be performed at baseline, week 4, and week 8

Other Outcomes (13)

• Change in the Screen for Child Anxiety-Related Emotional Disorders#SCARED#scores from baseline

  Assessments will be performed at baseline, week 4, and week 8

• Change in Hamilton Anxiety Scale (HAMA#scores from baseline

  Assessments will be performed at baseline, week 4, and week 8

• Change in suicide risk on the Columbia Suicide Severity Rating Scale (C-SSRS ) scores from baseline

  Assessments will be performed at baseline, week 4, and week 8

Study Arms (2)

Sertraline combined with compound probiotics group

EXPERIMENTAL

Phase 1: Weeks 1-4, the starting dose of sertraline is 25 mg/day, adjusted according to the clinical assessment of the psychiatrist, with a dosage range of 25-150 mg/day. By week 4, the sertraline dosage should reach at least 150 mg/day; compound probiotic powder, 1 sachet/day. Phase 2: Weeks 5-8, the sertraline dosage is 150-200 mg/day, adjusted according to the clinical assessment of the psychiatrist; compound probiotic powder, 1 sachet/day.

Drug: Sertraline

Sertraline combined with placebo group

EXPERIMENTAL

Phase 1: Weeks 1-4, the starting dose of sertraline is 25 mg/day, adjusted according to the clinical assessment of the psychiatrist, with a dosage range of 25-150 mg/day. By week 4, the sertraline dosage should reach at least 150 mg/day; placebo powder, 1 sachet/day. Phase 2: Weeks 5-8, the sertraline dosage is 150-200 mg/day, adjusted according to the clinical assessment of the psychiatrist; placebo powder, 1 sachet/day.

Drug: Sertraline

Interventions

Sertraline DRUG

Weeks 1-4, the starting dose of sertraline is 25 mg/day, adjusted according to the clinical assessment of the psychiatrist, with a dosage range of 25-150 mg/day. By week 4, the sertraline dosage should reach at least 150 mg/day; placebo powder, 1 sachet/day.

Sertraline combined with compound probiotics group; Sertraline combined with placebo group

Eligibility Criteria

• Age: 12 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• First Affiliated Hospital of Chongqing Medical University: lead

Study Sites (1)

The Affiliated Hospital of Chongqing Medical University

Chongqing, Yuzhong, 400010, China

RECRUITING

MeSH Terms

Conditions

Depressive Disorder, Major

Interventions

Sertraline

Condition Hierarchy (Ancestors)

Depressive Disorder; Mood Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

1-Naphthylamine; Amines; Organic Chemicals; Naphthalenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Polycyclic Compounds

Central Study Contacts

Teng Teng

CONTACT

+86 18883368354; tengteng@hospital.cqmu.edu.cn

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research Associate

Study Record Dates

• First Submitted: June 9, 2026
• First Posted: June 12, 2026
• Study Start (Estimated): October 1, 2026
• Primary Completion (Estimated): October 1, 2028
• Study Completion (Estimated): October 1, 2028
• Last Updated: June 12, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)