Sertraline Combined With Multi-Strain Probiotics for Adolescent Depression
2026년 6월 9일 업데이트: Teng Teng, First Affiliated Hospital of Chongqing Medical University
A Study on the Efficacy and Safety of Sertraline Combined With Multi-Strain Probiotics in Treating Adolescent Patients With Depression: A Multi-Center Randomized Controlled Clinical Trial
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.
연구 개요
연구 유형
중재적
등록 (추정된)
120
단계
- 2 단계
연락처 및 위치
이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.
연구 연락처
- 이름: Teng Teng
- 전화번호: +86 18883368354
- 이메일: tengteng@hospital.cqmu.edu.cn
연구 장소
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Yuzhong
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Chongqing, Yuzhong, 중국, 400010
- 모병
- The Affiliated Hospital of Chongqing Medical University
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연락하다:
- Teng Teng
- 전화번호: +18883368354
- 이메일: tengteng@hospital.cqmu.edu.cn
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참여기준
연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.
자격 기준
공부할 수 있는 나이
- 어린이
- 성인
건강한 자원 봉사자를 받아들입니다
아니
설명
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
공부 계획
이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 네 배로
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
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실험적: Sertraline combined with compound probiotics group
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. |
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.
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실험적: Sertraline combined with placebo group
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. |
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.
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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Change in Children's Depression Rating Scale - Revised (CDRS-R) scores
기간: Assessments will be performed at baseline, week 4, and week 8
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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.
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Assessments will be performed at baseline, week 4, and week 8
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Change in Baker Depression Scale#BDI# scores from baseline
기간: Assessments will be performed at baseline, week 4, and week 8
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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.
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Assessments will be performed at baseline, week 4, and week 8
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기타 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Change in Young Mania Rating Scale (YMRS) scores from baseline
기간: Assessments will be performed at baseline, week 4, and week 8
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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.
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Assessments will be performed at baseline, week 4, and week 8
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Changes in Ruminative Response Scale (RRS) scores from baseline
기간: Assessments will be performed at baseline, week 4, and week 8
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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.
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Assessments will be performed at baseline, week 4, and week 8
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Changes in Connor-Davidson Resilience Scale (CD-RISC) scores from baseline
기간: Assessments will be performed at baseline, week 4, and week 8
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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.
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Assessments will be performed at baseline, week 4, and week 8
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Changes in Pediatric Quality of Life Inventory™ Version 4.0 Scale (PedsQL™) scores from baseline
기간: Assessments will be performed at baseline, week 4, and week 8
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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.
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Assessments will be performed at baseline, week 4, and week 8
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Change in Pittsburgh Sleep Quality Index (PSQI) scores from baseline
기간: Assessments will be performed at baseline, Week 4, and Week 8
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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.
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Assessments will be performed at baseline, Week 4, and Week 8
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Changes in Clinical Global Impressions - Severity (CGI-S) scores from baseline
기간: Assessments will be performed at baseline, week 4, and week 8
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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.
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Assessments will be performed at baseline, week 4, and week 8
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Changes in Clinical global impressions-improvement (CGI-I) scores from baseline
기간: Assessments will be performed at baseline, week 4, and week 8
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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.
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Assessments will be performed at baseline, week 4, and week 8
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Change in the Screen for Child Anxiety-Related Emotional Disorders#SCARED#scores from baseline
기간: Assessments will be performed at baseline, week 4, and week 8
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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.
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Assessments will be performed at baseline, week 4, and week 8
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Change in Hamilton Anxiety Scale (HAMA#scores from baseline
기간: Assessments will be performed at baseline, week 4, and week 8
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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.
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Assessments will be performed at baseline, week 4, and week 8
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Change in suicide risk on the Columbia Suicide Severity Rating Scale (C-SSRS ) scores from baseline
기간: Assessments will be performed at baseline, week 4, and week 8
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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
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Medication adherence
기간: Assessments will be performed at week 4, and week 8
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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.
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Assessments will be performed at week 4, and week 8
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Changes in Gastrointestinal Symptom Rating Scale (GSRS) scores from baseline
기간: Changes from baseline to week 4 and week 8
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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
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Changes in Childhood Trauma Questionnaire (CTQ) scores from baseline
기간: Assessments will be performed at baseline, week 4, and week 8
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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.
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Assessments will be performed at baseline, week 4, and week 8
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공동 작업자 및 조사자
여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.
연구 기록 날짜
이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.
연구 주요 날짜
연구 시작 (추정된)
2026년 10월 1일
기본 완료 (추정된)
2028년 10월 1일
연구 완료 (추정된)
2028년 10월 1일
연구 등록 날짜
최초 제출
2026년 6월 9일
QC 기준을 충족하는 최초 제출
2026년 6월 9일
처음 게시됨 (실제)
2026년 6월 12일
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
2026년 6월 12일
QC 기준을 충족하는 마지막 업데이트 제출
2026년 6월 9일
마지막으로 확인됨
2026년 6월 1일
추가 정보
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .