A Phase 2 interventional study of Sertraline combined with Lactobacillus crispatus and Sertraline combined with placebo in Major Depressive Disorder (MDD) and Probiotic Intervention, sponsored by First Affiliated Hospital of Chongqing Medical University. Recruiting at 2 sites in China. Open to participants aged 12 Years to 18 Years. Per ClinicalTrials.gov, last updated 2026-06-15.
Sponsored by First Affiliated Hospital of Chongqing Medical University · Phase 2, Interventional, and Treatment
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
Exclusion criteria
Combination Product: Sertraline combined with Lactobacillus crispatus
Combination Product: Sertraline combined with placebo
Phase 1 (Weeks 1-4): Sertraline will be initiated at 25 mg/day and titrated according to clinical judgment, with a permissible dose range of 25-150 mg/day. By Week 4, the sertraline dose will reach a minimum of 150 mg/day. Concomitantly, Lactobacillus crispatus powder will be administered at 1 sachet/day (1×10⁹ CFU/sachet). Phase 2 (Weeks 5-8): Sertraline will be maintained at 150-200 mg/day, with dose adjustments guided by the psychiatrist's clinical judgment. Lactobacillus crispatus powder will remain at 1 sachet/day (1×10⁹ CFU/sachet).
Phase 1 (Weeks 1-4): Sertraline will be initiated at 25 mg/day based on the psychiatrist's clinical assessment, with a permissible dose range of 25-150 mg/day. By Week 4, the sertraline dose will attain at least 150 mg/day, with concomitant placebo powder at 1 sachet/day. Phase 2 (Weeks 5-8): Sertraline will be maintained at 150-200 mg/day, with dose adjustments guided by the psychiatrist's clinical assessment. Placebo powder will be maintained at 1 sachet/day.
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.
Time frame: Assessments will be performed at baseline, week 4, and week 8
Change in Baker Depression Scale（BDI） scores from baseline
The Beck Depression Inventory (BDI) is a self-report inventory measuring the severity of depression. It consists of 21 items with 4 answer options each. The total score ranges from 0 to 63, with higher scores indicating more severe depressive symptoms.
Time frame: Assessments will be performed at baseline, week 4, and week 8
Change in the Screen for Child Anxiety-Related Emotional Disorders（SCARED）scores from baseline
The Screen for Child Anxiety-Related Emotional Disorders (SCARED) scale will be administered to assess anxiety symptoms. Responses are made on a 3-point scale: 0 = "not true or hardly ever true", 1 = "somewhat true or sometimes true," and 2 = "very true or often true". Higher total scores indicate higher levels of anxiety.
Time frame: Assessments will be performed at baseline, week 4, and week 8
Change in Hamilton Anxiety Scale (HAMA）scores from baseline
The Hamilton Anxiety Scale (HAMA) will be used to assess anxiety symptoms. Responses are made on a 5-point Likert scale (0 = Not present, to 4 = Very severe). Higher total scores indicate more severe anxiety symptoms.
Time frame: 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
The Columbia-Suicide Severity Rating Scale (C-SSRS) will be used assess the severity of suicidal ideation and suicidal behavior. It evaluates four core domains: suicidal ideation (5 items), intensity of ideation, (5-point scale), suicidal behaviors (actual, aborted, interrupted attempts, and preparatory acts), and lethality of suicide attempts. Higher scores indicate more severe suicidal ideation, and any suicidal behavior denotes elevated acute suicide risk.
Time frame: Assessments will be performed at baseline, week 4, and week 8
Change in Young Mania Rating Scale (YMRS) scores from baseline
The Young Mania Rating Scale (YMRS) will be used to assess the severity of manic symptoms. It is a clinician-rated scale with 11 items. Total scores range from 0 to 60, with higher scores indicating more severe manic symptoms.
Time frame: Assessments will be performed at baseline, week 4, and week 8
Changes in Ruminative Response Scale (RRS) scores from baseline
The Ruminative Response Scale (RRS) will be used to assess rumination. Responses are made on a 4-point Likert scale (1 = never to 4 = always), with total score ranges from 22 to 88. Higher scores indicate greater intensity of rumination.
Time frame: Assessments will be performed at baseline, week 4, and week 8
Medication adherence
Medication adherence will be assessed by the pill count method. The adherence rate will be calculated according to the following formula: Adherence rate= (Number of dispensed tablets-Number of returned unused tablets)/ (Daily prescribed tablets × Days between two visits) ×100% Adherence ≥ 80% was defined as adequate adherence.
Time frame: Assessments will be performed at week 4, and week 8
Changes in Connor-Davidson Resilience Scale (CD-RISC) scores from baseline
The Connor-Davidson Resilience Scale (CD-RISC) is used to measure psychological resilience. Responses are made on a 5-point Likert scale (0 = never to 4 = always). The total score can range from 0 to 100, with higher scores indicating greater resilience.
Time frame: Assessments will be performed at baseline, week 4, and week 8
Changes in Pediatric Quality of Life Inventory™ Version 4.0 Scale (PedsQL™) scores from baseline
The Pediatric Quality of Life Inventory 4.0 generic core scales (PedsQL4.0) is a self-rated scale for assessing pediatric health-related quality of life. Responses are made on a 5-point Likert scale (1 = strongly disagree to 5 = strongly agree). Higher scores indicate better quality of life.
Time frame: Assessments will be performed at baseline, week 4, and week 8
Change in Pittsburgh Sleep Quality Index (PSQI) scores from baseline
The Pittsburgh Sleep Quality Index (PSQI) will be used for evaluating subjective sleep quality. Responses are made on a 4-point Likert scale, with total score ranges from 0 to 21. Higher scores indicate poorer overall sleep quality.
Time frame: Assessments will be performed at baseline, Week 4, and Week 8
Changes in Gastrointestinal Symptom Rating Scale (GSRS) scores from baseline
The Gastrointestinal Symptom Rating Scale (GSRS), a self-rated questionnaire, will be used to assess the severity of gastrointestinal symptoms. Responses are made on a 7-point Likert scale (1 = not at all to 7 = extremely severe). Higher scores indicate more severe gastrointestinal symptoms.
Time frame: Changes from baseline to week 4 and week 8
Changes in Childhood Trauma Questionnaire (CTQ) scores from baseline
The Childhood Trauma Questionnaire (CTQ) will be used to assess childhood trauma. Responses were made on a 5-point Likert scale (1 = never to 5 = always). Higher scores indicate greater frequency and severity of child maltreatment experiences.
Time frame: Assessments will be performed at baseline, week 4, and week 8
Changes in Clinical Global Impressions - Severity (CGI-S) scores from baseline
The Clinical Global Impressions-Severity (CGI-S), a clinician-rated outcome measure, was used to evaluate the overall severity of depressive symptoms. Higher CGI-S scores represent more severe overall illness.
Time frame: Assessments will be performed at baseline, week 4, and week 8
Changes in Clinical global impressions-improvement (CGI-I) scores from baseline
The Clinical Global Impressions-Improvement (CGI-I) is an 8-point clinician-rated scale ranging from 0 to 7, which will be used to assess the overall improvement in depressive symptoms compared with baseline. Lower scores indicate greater clinical improvement.
Time frame: Assessments will be performed at baseline, week 4, and week 8
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First Affiliated Hospital of Chongqing Medical University