Status:
COMPLETED
Efficacy Study in Phytotherapy of an Association of Plants in the Improvement of Psychological Well-being
Lead Sponsor:
Larena SAS
Collaborating Sponsors:
Université Catholique de Louvain
Conditions:
Psychological Well-being
Eligibility:
All Genders
18-75 years
Phase:
NA
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 episo...
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 ...
Eligibility Criteria
Inclusion
- 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
- 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 ;
Key Trial Info
Start Date :
April 26 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 7 2024
Estimated Enrollment :
126 Patients enrolled
Trial Details
Trial ID
NCT05199545
Start Date
April 26 2022
End Date
May 7 2024
Last Update
July 15 2025
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
CICN - Université Catholique de Louvain
Louvain-la-Neuve, Belgium