Efficacy Study in Phytotherapy of an Association of Plants in the Improvement of Psychological Well-being
- Conditions
- Psychological Well-being
- Interventions
- Dietary Supplement: Dietary supplementOther: Placebo
- Registration Number
- NCT05199545
- Lead Sponsor
- Larena SAS
- Brief Summary
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).
- Detailed Description
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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 126
- 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.
- 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 ;
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Dietary supplement group Dietary supplement 2 tablets / day for 6 weeks of the dietary supplement (Rhodiola rosea L. and Crocus sativus L.), to be taken every day in the morning with a large glass of water, from D1 to D42. Placebo group Placebo 2 tablets / day for 6 weeks of the placebo, to be taken every day in the morning with a large glass of water, from D1 to D42.
- Primary Outcome Measures
Name Time Method Evolution of depressive symptoms through Hamilton Depression Scale (HAM-D) at the end of the study 42 days Score HAM-D at D42, adjusted to the value at D0 minimum = 0 and maximum = 53 higher score means a worse outcome
- Secondary Outcome Measures
Name Time Method Evolution of depressive symptoms through HAM-D during the study 42 days Evolution of score HAM-D between D0, D21 and D42
Rate of responding participants (decrease of ≥ 5 points) at D21 21 days HAM-D score showing a decrease of ≥ 5 points compared to D0
Rate of responding participants (decrease of ≥ 5 points) at D42 42 days HAM-D score showing a decrease of ≥ 5 points compared to D0
Evolution of depressive symptoms through Hospital Anxiety and Depression Scale - Depression (HADS-D) during the study 42 days Evolution of sub-scores HADS-D between D0, D21 and D42 minimum = 0 and maximum = 21 higher score means a worse outcome
Evolution of physician's general impression of the symptoms evolution during the study 42 days Evolution of Clinical Global Impression-Improvement (CGI-I) between D0, D21 and D42 minimum = 1 and maximum = 7 higher score means a worse outcome
Patient satisfaction with complementation at D42 42 days 5-point Likert scale
Concomitant drug use 42 days Number and type of concomitant drugs
Compliance at D42 42 days Counting of therapeutic units at D42
Rate of participants in remission at D21 21 days score HAM-D ≤ 7
Evolution of depressive symptoms through Hospital Anxiety and Depression Scale - Anxiety (HADS-A) during the study 42 days Evolution of sub-scores HADS-A between D0, D21 and D42 minimum = 0 and maximum = 21 higher score means a worse outcome
Evolution of patient's general impression of the symptoms evolution during the study 42 days Evolution of Patient Global Impression-Improvement (PGI-I) between D0, D21 and D42 minimum = 1 and maximum = 7 higher score means a worse outcome
Compliance at D21 21 days Counting of therapeutic units at D21
Evolution of physician's general impression of the symptoms during the study 42 days Evolution of Clinical Global Impression-Severity (CGI-S) between D0, D21 and D42 minimum = 1 and maximum = 7 higher score means a worse outcome
Adverse events 42 days Number and type of adverse events
Evolution of patient's functional disability in his or her professional, social and family life during the study 42 days Evolution of Sheehan Disability Score (SDS) between D0, D21 and D42 minimum = 0 and maximum = 44 higher score means a worse outcome
Number of intercurrent visits 42 days Number of intercurrent visits
Evolution of depressive symptoms through HAM-D sub-scores during the study 42 days Evolution of sub-scores HAM-D between D0, D21 and D42
Rate of responding participants (decrease of ≥ 3 points) at D21 21 days HAM-D score showing a decrease of ≥ 3 points compared to D0
Rate of responding participants (decrease of ≥ 3 points) at D42 42 days HAM-D score showing a decrease of ≥ 3 points compared to D0
Rate of participants in remission at D42 42 days score HAM-D ≤ 7
Patient satisfaction with complementation at D21 21 days 5-point Likert scale (minimum = 1 and maximum = 5) higher score means a better satisfaction
Management prescribed or advised at the end of follow-up 42 days Rate of participants on the same dietary supplement, antidepressant medication, other or without treatment at the end of the study
Trial Locations
- Locations (1)
CICN - Université Catholique de Louvain
🇧🇪Louvain-la-Neuve, Belgium