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
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 120
- 试验地点
- 1
研究概览
简要总结
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.
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
研究者
Teng Teng
Research Associate
First Affiliated Hospital of Chongqing Medical University