Multicenter Interventional Real-world Study Evaluating the Impact of the Dietary Supplement GynMDD Administered as an add-on to Supportive Psychotherapy in Patients With Mild to Moderate Depression.
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 168
- 试验地点
- 1
- 主要终点
- Change in MADRS Score
研究概览
简要总结
The goal of this clinical trial is to learn whether the dietary supplement GynMDD, when taken as an add-on to supportive psychotherapy, can improve symptoms of mild to moderate depression in adults aged 18 to 65. The main questions it aims to answer are:
Does adding GynMDD to supportive psychotherapy lead to a greater reduction in depressive symptoms (measured by the MADRS scale) compared with supportive psychotherapy plus placebo?
Does the supplement also improve digestive well-being and influence gut microbiota profiles over the course of treatment?
Researchers will compare patients receiving supportive psychotherapy + GynMDD to those receiving supportive psychotherapy + placebo to see if GynMDD provides additional benefits beyond standard care.
Participants will:
- Attend regular appointments with their general practitioner
- Complete one supportive psychotherapy session per week for 8 weeks
- Take a daily dose of GynMDD or placebo
- Complete weekly self-assessment questionnaires on mood, digestive symptoms, and any side effects via a mobile app
- Provide two stool samples (at the start and end of the study) for microbiota analysis
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
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adults aged 18 to 65 years, inclusive
- •The main reason for consultation is a suspected depressive episode
- •MADRS score between 15 and 34, indicating mild to moderate depression
- •No suicidal risk, defined as a score of 0 on item 10 of the MADRS scale
- •Body Mass Index (BMI) between 19 and 29 (inclusive)
- •Signed informed consent, confirming that the participant understands the purpose and requirements of the study and agrees to comply with the procedures (including scheduled supportive psychotherapy sessions)
- •Affiliation with the French national health insurance system or beneficiary of such coverage
排除标准
- •History of severe psychiatric disorders or currently undergoing supportive psychotherapy
- •Confirmed suicidal risk, defined as a score between 1 and 6 on MADRS item 10
- •Current treatment with antidepressants (AD)
- •MADRS score > 34
- •Conditions in which probiotic administration is not recommended (e.g., immunodeficiency, presence of a venous catheter)
- •Allergy to any component of the placebo or the GynMDD dietary supplement
- •Current consumption of probiotic-based dietary supplements
- •Recent infectious episodes that may require antibiotic therapy
- •Current treatment with anxiolytics
- •Long-term chronic anti-inflammatory treatment
- •Alcohol abuse, defined as a consumption of 10 standard drinks per week or more
- •Use of illicit drugs or substances of abuse
- •Inability to provide informed consent
- •Participation in another clinical study within the past 12 months
- •Pregnant or breastfeeding women
- •Patients without health insurance
- •Individuals under legal protection, guardianship, trusteeship, or any other protective measure
研究组 & 干预措施
Supportive Psychotherapy + GynMDD
Supportive Psychotherapy and Dietary Supplement
干预措施: GynMDD (Dietary Supplement)
Supportive Psychotherapy + Placebo
Supportive Psychotherapy and Placebo
干预措施: Placebo (Other)
结局指标
主要结局
Change in MADRS Score
时间窗: Baseline (V0) to Week 8 (V2)
Assessment of depressive symptoms using the Montgomery-Åsberg Depression Rating Scale (MADRS).
次要结局
- Fecal Microbiota Metagenomic Profile (Shotgun Sequencing)(Baseline (V0) and Week 8 (V2))
- Adverse Events Reporting(Weekly until 8 week and at Week 4 (V1), Week 8 (V2))
- Proportion of participants requiring initiation of antidepressant therapy(Up to Week 8 (V2))
- Change in Digestive Symptom Score (WGO scale)(Baseline (V0), Week 4 (V1), Week 8 (V2))
- Change in PHQ-9 Self-Reported Depression Score(Weekly for 8 weeks)
- Change in GSRS-IBS Digestive Symptom Score(Weekly for 8 weeks)