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

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).

Study Overview

• Status: Completed
• Conditions: Psychological Well-being
• Intervention / Treatment: Dietary supplement: Dietary supplement; Other: Placebo

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.

• Study Type: Interventional
• Enrollment (Actual): 126
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Belgium
  • Louvain-la-Neuve, Belgium
    • CICN - Université Catholique de Louvain

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 ;

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Dietary supplement group; 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; Dietary supplement under study is based on Rhodiola rosea L. and Crocus sativus L. extracts
Placebo Comparator: Placebo group; 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; Placebo of the dietary supplement

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Larena SAS
• Collaborators: Université Catholique de Louvain

Study record dates

Study Major Dates

• Study Start (Actual): April 26, 2022
• Primary Completion (Actual): May 7, 2024
• Study Completion (Actual): May 7, 2024

Study Registration Dates

• First Submitted: January 6, 2022
• First Submitted That Met QC Criteria: January 6, 2022
• First Posted (Actual): January 20, 2022

Study Record Updates

• Last Update Posted (Actual): July 15, 2025
• Last Update Submitted That Met QC Criteria: July 10, 2025
• Last Verified: July 1, 2025

More Information

Terms related to this study

• Other Study ID Numbers: PiL-Clin-ROSADE-021

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No