Efficacy and Safety of Sertraline Combined With Lactobacillus Crispatus in Adolescents With Depression

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