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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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Sertraline combined with Lactobacillus crispatus group | Experimental |
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| Sertraline combined with placebo group | Active Comparator |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Sertraline combined with Lactobacillus crispatus | Combination Product | 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). |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Assessments will be performed at baseline, week 4, and week 8 |
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Inclusion criteria
Exclusion criteria
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Teng Teng | Contact | +86 18883368354 | tengteng@hospital.cqmu.edu.cn |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Affiliated Dazu's Hospital of Chongqing Medical University | Not yet recruiting | Longgang | Chongqing Municipality | 404100 | China |
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| Sertraline combined with placebo | Combination Product | 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. |
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| 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | Assessments will be performed at baseline, week 4, and week 8 |
| The Affiliated Hospital of Chongqing Medical University | Recruiting | Chongqing | Yuzhong | 400010 | China |
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| ID | Term |
|---|---|
| D003865 | Depressive Disorder, Major |
| ID | Term |
|---|---|
| D003866 | Depressive Disorder |
| D019964 | Mood Disorders |
| D001523 | Mental Disorders |
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