Efficacy Study in Phytotherapy of an Association of Plants in the Improvement of Psychological Well-being

Study Overview
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Brief Summary
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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
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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.

Official Title
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Efficacy Study in Phytotherapy of an Association of Plants in the Improvement of Psychological Well-being

Conditions
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Psychological Well-being

Intervention / Treatment
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* Dietary Supplement: Dietary supplement
* Other: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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. Exclusion Criteria: 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 ;

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Dietary supplement group<br>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. | Dietary Supplement: Dietary supplement<br>* Dietary supplement under study is based on Rhodiola rosea L. and Crocus sativus L. extracts<br>|
| Placebo Comparator: Placebo group<br>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. | Other: Placebo<br>* Placebo of the dietary supplement<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evolution of depressive symptoms through Hamilton Depression Scale (HAM-D) at the end of the study | Score HAM-D at D42, adjusted to the value at D0 minimum = 0 and maximum = 53 higher score means a worse outcome | 42 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evolution of depressive symptoms through HAM-D during the study | Evolution of score HAM-D between D0, D21 and D42 | 42 days | 
| Evolution of depressive symptoms through HAM-D sub-scores during the study | Evolution of sub-scores HAM-D between D0, D21 and D42 | 42 days | 
| Rate of responding participants (decrease of ≥ 3 points) at D21 | HAM-D score showing a decrease of ≥ 3 points compared to D0 | 21 days | 
| Rate of responding participants (decrease of ≥ 3 points) at D42 | HAM-D score showing a decrease of ≥ 3 points compared to D0 | 42 days | 
| Rate of responding participants (decrease of ≥ 5 points) at D21 | HAM-D score showing a decrease of ≥ 5 points compared to D0 | 21 days | 
| Rate of responding participants (decrease of ≥ 5 points) at D42 | HAM-D score showing a decrease of ≥ 5 points compared to D0 | 42 days | 
| Rate of participants in remission at D21 | score HAM-D ≤ 7 | 21 days | 
| Rate of participants in remission at D42 | score HAM-D ≤ 7 | 42 days | 
| Evolution of depressive symptoms through Hospital Anxiety and Depression Scale - Depression (HADS-D) during the study | Evolution of sub-scores HADS-D between D0, D21 and D42 minimum = 0 and maximum = 21 higher score means a worse outcome | 42 days | 
| Evolution of depressive symptoms through Hospital Anxiety and Depression Scale - Anxiety (HADS-A) during the study | Evolution of sub-scores HADS-A between D0, D21 and D42 minimum = 0 and maximum = 21 higher score means a worse outcome | 42 days | 
| Evolution of physician's general impression of the symptoms during the study | Evolution of Clinical Global Impression-Severity (CGI-S) between D0, D21 and D42 minimum = 1 and maximum = 7 higher score means a worse outcome | 42 days | 
| Evolution of physician's general impression of the symptoms evolution during the study | Evolution of Clinical Global Impression-Improvement (CGI-I) between D0, D21 and D42 minimum = 1 and maximum = 7 higher score means a worse outcome | 42 days | 
| Evolution of patient's general impression of the symptoms evolution during the study | Evolution of Patient Global Impression-Improvement (PGI-I) between D0, D21 and D42 minimum = 1 and maximum = 7 higher score means a worse outcome | 42 days | 
| Adverse events | Number and type of adverse events | 42 days | 
| Evolution of patient's functional disability in his or her professional, social and family life during the study | Evolution of Sheehan Disability Score (SDS) between D0, D21 and D42 minimum = 0 and maximum = 44 higher score means a worse outcome | 42 days | 
| Patient satisfaction with complementation at D21 | 5-point Likert scale (minimum = 1 and maximum = 5) higher score means a better satisfaction | 21 days | 
| Patient satisfaction with complementation at D42 | 5-point Likert scale | 42 days | 
| Number of intercurrent visits | Number of intercurrent visits | 42 days | 
| Concomitant drug use | Number and type of concomitant drugs | 42 days | 
| Compliance at D21 | Counting of therapeutic units at D21 | 21 days | 
| Compliance at D42 | Counting of therapeutic units at D42 | 42 days | 
| Management prescribed or advised at the end of follow-up | Rate of participants on the same dietary supplement, antidepressant medication, other or without treatment at the end of the study | 42 days |