Efficacy and Safety of Sertraline Combined With Lactobacillus Crispatus in Adolescents With Depression : A Multicenter Randomized Controlled Trial
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Change in Children's Depression Rating Scale - Revised (CDRS-R) scores
研究概览
简要总结
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
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 12 Years 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
Sertraline combined with placebo group
干预措施: Sertraline combined with placebo (Combination Product)
Sertraline combined with Lactobacillus crispatus group
干预措施: Sertraline combined with Lactobacillus crispatus (Combination Product)
结局指标
主要结局
Change in Children's Depression Rating Scale - Revised (CDRS-R) scores
时间窗: 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.
次要结局
- Change in Baker Depression Scale（BDI-II） scores from baseline(Assessments will be performed at baseline, week 4, and week 8)
- Change in suicide risk from baseline on the Columbia Suicide Severity Rating Scale (C-SSRS ) scores from baseline(Assessments will be performed at baseline, week 4, and week 8)
- Morisky Medication Adherence Scale - 8 (MMAS-8) score(Assessments will be performed at week 4, and week 8)
- Change in the Screen for Child Anxiety-Related Emotional Disorders（SCARED）scores from baseline(Assessments will be performed at baseline, week 4, and week 8)
- Change in Hamilton Anxiety Scale (HAMA）scores from baseline(Assessments will be performed at baseline, week 4, and week 8)
- Change in Young Mania Rating Scale (YMRS) scores from baseline(Assessments will be performed at baseline, week 4, and week 8)
- Changes in Ruminative Response Scale (RRS) scores from baseline(Assessments will be performed at baseline, week 4, and week 8)
- Changes in Clinical Global Impressions - Severity (CGI-S) scores from baseline(Assessments will be performed at baseline, week 4, and week 8)
- Changes in Connor-Davidson Resilience Scale (CD-RISC) scores from baseline(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(Assessments will be performed at baseline, week 4, and week 8)
- Change in Pittsburgh Sleep Quality Index (PSQI) scores from baseline(Assessments will be performed at baseline, Week 4, and Week 8)
- Changes in Gastrointestinal Symptom Rating Scale (GSRS) scores from baseline(Changes from baseline to week 4 and week 8)
- Changes in Childhood Trauma Questionnaire (CTQ) scores from baseline(Assessments will be performed at baseline, week 4, and week 8)
- Change in Baker Depression Scale（BDI） scores from baseline(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(Assessments will be performed at baseline, week 4, and week 8)
- Medication adherence(Assessments will be performed at week 4, and week 8)
- Changes in Clinical global impressions-improvement (CGI-I) scores from baseline(Assessments will be performed at baseline, week 4, and week 8)
研究者
Teng Teng
Research Associate
First Affiliated Hospital of Chongqing Medical University