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

Last updated: July 10, 2025
Sponsor: Larena SAS
Overall Status: Completed

Phase

N/A

Condition

N/A

Treatment

Dietary supplement

Placebo

Clinical Study ID

NCT05199545
PiL-Clin-ROSADE-021
  • Ages 18-75
  • All Genders

Study 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).

Eligibility Criteria

Inclusion

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 orpsychotherapeutic treatment ;

  • Depressive disorder not requiring, in the opinion of the investigator, initiation ofantidepressant drug therapy ;

  • Patient able to understand the study information, read the information leaflet, andwilling to sign the consent form ;

  • French speaking patient.

Exclusion

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) orhaving 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 knowneffect 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 productunder study (rhodiola or saffron) ;

  • Patient unable to understand information related to the study (mental or linguisticdisability) ;

  • Patient participating or having participated in the previous 3 months in anotherclinical trial ;

Study Design

Total Participants: 126
Treatment Group(s): 2
Primary Treatment: Dietary supplement
Phase:
Study Start date:
April 26, 2022
Estimated Completion Date:
May 07, 2024

Study 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.

Connect with a study center

  • CICN - Université Catholique de Louvain

    Louvain-la-Neuve,
    Belgium

    Site Not Available

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