Sertraline Combined With Multi-Strain Probiotics for Adolescent Depression
2026年6月9日 更新者：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.
調査の概要
研究の種類
介入
入学 (推定)
120
段階
- フェーズ2
連絡先と場所
このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。
研究連絡先
- 名前：Teng Teng
- 電話番号：+86 18883368354
- メール：tengteng@hospital.cqmu.edu.cn
研究場所
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Yuzhong
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Chongqing、Yuzhong、中国、400010
- 募集
- The Affiliated Hospital of Chongqing Medical University
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コンタクト：
- Teng Teng
- 電話番号：+18883368354
- メール：tengteng@hospital.cqmu.edu.cn
-
-
参加基準
研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。
適格基準
就学可能な年齢
- 子
- 大人
健康ボランティアの受け入れ
いいえ
説明
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
研究計画
このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：処理
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：4倍
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
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実験的：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.
|
|
実験的：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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この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Change in Children's Depression Rating Scale - Revised (CDRS-R) scores
時間枠：Assessments will be performed at baseline, week 4, and week 8
|
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
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Change in Baker Depression Scale#BDI# scores from baseline
時間枠：Assessments will be performed at baseline, week 4, and week 8
|
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
|
その他の成果指標
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Change in Young Mania Rating Scale (YMRS) scores from baseline
時間枠：Assessments will be performed at baseline, week 4, and week 8
|
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
時間枠：Assessments will be performed at baseline, week 4, and week 8
|
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
|
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Changes in Connor-Davidson Resilience Scale (CD-RISC) scores from baseline
時間枠：Assessments will be performed at baseline, week 4, and week 8
|
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
|
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Changes in Pediatric Quality of Life Inventory™ Version 4.0 Scale (PedsQL™) scores from baseline
時間枠：Assessments will be performed at baseline, week 4, and week 8
|
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
|
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Change in Pittsburgh Sleep Quality Index (PSQI) scores from baseline
時間枠：Assessments will be performed at baseline, Week 4, and Week 8
|
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
|
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Changes in Clinical Global Impressions - Severity (CGI-S) scores from baseline
時間枠：Assessments will be performed at baseline, week 4, and week 8
|
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
時間枠：Assessments will be performed at baseline, week 4, and week 8
|
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
|
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Change in the Screen for Child Anxiety-Related Emotional Disorders#SCARED#scores from baseline
時間枠：Assessments will be performed at baseline, week 4, and week 8
|
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
|
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Change in Hamilton Anxiety Scale (HAMA#scores from baseline
時間枠：Assessments will be performed at baseline, week 4, and week 8
|
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
時間枠：Assessments will be performed at baseline, week 4, and week 8
|
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
|
|
Medication adherence
時間枠：Assessments will be performed at week 4, and week 8
|
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 Gastrointestinal Symptom Rating Scale (GSRS) scores from baseline
時間枠：Changes from baseline to week 4 and week 8
|
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
時間枠：Assessments will be performed at baseline, week 4, and week 8
|
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
|
協力者と研究者
ここでは、この調査に関係する人々や組織を見つけることができます。
研究記録日
これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。
主要日程の研究
研究開始 (推定)
2026年10月1日
一次修了 (推定)
2028年10月1日
研究の完了 (推定)
2028年10月1日
試験登録日
最初に提出
2026年6月9日
QC基準を満たした最初の提出物
2026年6月9日
最初の投稿 (実際)
2026年6月12日
学習記録の更新
投稿された最後の更新 (実際)
2026年6月12日
QC基準を満たした最後の更新が送信されました
2026年6月9日
最終確認日
2026年6月1日
詳しくは
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。