NCT05199545已完成不适用
Efficacy Study in Phytotherapy of an Association of Plants in the Improvement of Psychological Well-being
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Larena SAS
- 入组人数
- 126
- 试验地点
- 2
- 主要终点
- Evolution of depressive symptoms through Hamilton Depression Scale (HAM-D) at the end of the study
研究概览
简要总结
The objective of the study is to compare the effect of a 6-week supplementation with a dietary supplement based on plant extracts to the effect of placebo, in patients with a moderate depressive episode (F32.1 by ICD10 definition) and with moderate symptoms (score HAM-D ≥ 16 and ≤ 23).
详细描述
Longitudinal, comparative, randomized, placebo-controlled interventional study in 2 parallel groups, double-blind, monocentre, aimed at demonstrating the superiority of the combination of plants over placebo on depressive symptoms.
Each patient will be followed for a maximum of 6 weeks, with 3 visits to the doctor.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥ 18 and ≤ 75 years old ;
- •Patient with a moderate depressive episode (F32.1 by ICD10 definition) ;
- •Score HAM-D ≥ 16 and ≤ 23 at inclusion, corresponding to moderate symptoms ;
- •Recent depression (less than 6 months), not managed by antidepressant or psychotherapeutic treatment ;
- •Depressive disorder not requiring, in the opinion of the investigator, initiation of antidepressant drug therapy ;
- •Patient able to understand the study information, read the information leaflet, and willing to sign the consent form ;
- •French speaking patient.
排除标准
- •Patient with a depressive disorder of another nature or any other mental illness (schizophrenia, bipolarity, alcohol or drug addiction, etc.);
- •Patient at risk of suicide (noted by the investigator, or HAM-D item 3 score > 2) or having attempted suicide in the last 5 years;
- •Depression felt for more than 6 months ;
- •Patient under psychotropic treatment (current or in the month preceding inclusion) (neuroleptic, anxiolytic, hypnotic);
- •Patient on beta-blocker therapy ;
- •Patient on dialysis ;
- •Patient using products containing piperine or St. John's wort, or having a known effect on mood in the last 30 days ;
- •Woman who is pregnant or breastfeeding, or has plans to become pregnant in the next 8 weeks ;
- •Patient with an allergy or contraindication to one of the components of the product under study (rhodiola or saffron) ;
- •Patient unable to understand information related to the study (mental or linguistic disability) ;
- •Patient participating or having participated in the previous 3 months in another clinical trial ;
结局指标
主要结局
Evolution of depressive symptoms through Hamilton Depression Scale (HAM-D) at the end of the study
时间窗: 42 days
Score HAM-D at D42, adjusted to the value at D0 minimum = 0 and maximum = 53 higher score means a worse outcome
次要结局
- Evolution of depressive symptoms through HAM-D during the study(42 days)
- Rate of responding participants (decrease of ≥ 5 points) at D21(21 days)
- Rate of responding participants (decrease of ≥ 5 points) at D42(42 days)
- Evolution of depressive symptoms through Hospital Anxiety and Depression Scale - Depression (HADS-D) during the study(42 days)
- Evolution of physician's general impression of the symptoms evolution during the study(42 days)
- Patient satisfaction with complementation at D42(42 days)
- Concomitant drug use(42 days)
- Compliance at D42(42 days)
- Rate of participants in remission at D21(21 days)
- Evolution of depressive symptoms through Hospital Anxiety and Depression Scale - Anxiety (HADS-A) during the study(42 days)
- Evolution of patient's general impression of the symptoms evolution during the study(42 days)
- Compliance at D21(21 days)
- Evolution of physician's general impression of the symptoms during the study(42 days)
- Adverse events(42 days)
- Evolution of patient's functional disability in his or her professional, social and family life during the study(42 days)
- Number of intercurrent visits(42 days)
- Evolution of depressive symptoms through HAM-D sub-scores during the study(42 days)
- Rate of responding participants (decrease of ≥ 3 points) at D21(21 days)
- Rate of responding participants (decrease of ≥ 3 points) at D42(42 days)
- Rate of participants in remission at D42(42 days)
- Patient satisfaction with complementation at D21(21 days)
- Management prescribed or advised at the end of follow-up(42 days)
研究者
研究点 (2)
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