Psychological Well-beingROSADENCT05199545
Efficacy Study in Phytotherapy of an Association of Plants in the Improvement of Psychological Well-being
A study testing Dietary supplement in people with Psychological Well-being, run by Larena SAS at 1 site in Belgium.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Psychological Well-being
- What is being tested?
- Dietary supplement
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 126 participants
- Where
- 1 siteBelgium
- Study dates
- 26 Apr 2022to 7 May 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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 ;
Show all 11Show fewer
- 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 ;
Trial locations and contacts
1 site in 1 country.
About this study
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).
Read the 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.
- Conditions
- Psychological Well-being
- Being tested
- Dietary supplement, Placebo
- Medical subject headings
- Psychological Well-Being
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dietary supplementDietary supplement
Dietary supplement under study is based on Rhodiola rosea L. and Crocus sativus L. extracts
PlaceboOther
Placebo of the dietary supplement
| Study group | Role | What they receive |
|---|---|---|
| Dietary supplement group | Experimental | 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. Receives: Dietary Supplement: Dietary supplement |
| Placebo group | Placebo comparator | 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. Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 42 days
Secondary outcomes (22)
Evolution of depressive symptoms through HAM-D during the study
Evolution of score HAM-D between D0, D21 and D42
Measured: 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
Measured: 42 days
Rate of responding participants (decrease of ≥ 3 points) at D21
HAM-D score showing a decrease of ≥ 3 points compared to D0
Measured: 21 days
Rate of responding participants (decrease of ≥ 3 points) at D42
HAM-D score showing a decrease of ≥ 3 points compared to D0
Measured: 42 days
Rate of responding participants (decrease of ≥ 5 points) at D21
HAM-D score showing a decrease of ≥ 5 points compared to D0
Measured: 21 days
Rate of responding participants (decrease of ≥ 5 points) at D42
HAM-D score showing a decrease of ≥ 5 points compared to D0
Measured: 42 days
Rate of participants in remission at D21
score HAM-D ≤ 7
Measured: 21 days
Rate of participants in remission at D42
score HAM-D ≤ 7
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 42 days
Adverse events
Number and type of adverse events
Measured: 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
Measured: 42 days
Patient satisfaction with complementation at D21
5-point Likert scale (minimum = 1 and maximum = 5) higher score means a better satisfaction
Measured: 21 days
Patient satisfaction with complementation at D42
5-point Likert scale
Measured: 42 days
Number of intercurrent visits
Number of intercurrent visits
Measured: 42 days
Concomitant drug use
Number and type of concomitant drugs
Measured: 42 days
Compliance at D21
Counting of therapeutic units at D21
Measured: 21 days
Compliance at D42
Counting of therapeutic units at D42
Measured: 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
Measured: 42 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jan 2022
- Study start26 Apr 2022
- Primary completion7 May 2024
- Study completion7 May 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Psychological Well-beingStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 126 participants (actual)
Sponsor and investigators
- Lead sponsor
- Larena SAS
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Université Catholique de Louvain
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05199545
- Sponsor's protocol ID
- PiL-Clin-ROSADE-021
- Acronym
- ROSADE
- Status last verified
- Jul 2025
- First submitted
- 6 Jan 2022
- Last updated
- 15 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy Study in Phytotherapy of an Association of Plants in the Improvement of Psychological Well-being
- ClinicalTrials.gov ID
- NCT05199545
- Acronym / sponsor ID
- ROSADE / PiL-Clin-ROSADE-021
- Conditions
- Psychological Well-being
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 126 participants (actual)
- Lead sponsor
- Larena SASIndustry (pharma, biotech, devices)
- Collaborators
- Université Catholique de Louvain
- Study start
- 26 Apr 2022 (actual)
- Primary completion
- 7 May 2024 (actual)
- Study completion
- 7 May 2024 (actual)
- First posted
- 20 Jan 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Dietary supplement group | Experimental | Dietary Supplement: Dietary supplement2 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 comparator | Other: Placebo2 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. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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 ;
Key exclusion criteria (11 listed)
- 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 ;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Dietary supplementDietary supplement under study is based on Rhodiola rosea L. and Crocus sativus L. extracts | Dietary supplement | Dietary supplement group |
| PlaceboPlacebo of the dietary supplement | Other | Placebo group |
Primary outcome
Evolution of depressive symptoms through Hamilton Depression Scale (HAM-D) at the end of the study
Time frame: 42 days
Score HAM-D at D42, adjusted to the value at D0 minimum = 0 and maximum = 53 higher score means a worse outcome
22 secondary outcomes
Evolution of depressive symptoms through HAM-D during the study
Time frame: 42 days
Evolution of depressive symptoms through HAM-D sub-scores during the study
Time frame: 42 days
Rate of responding participants (decrease of ≥ 3 points) at D21
Time frame: 21 days
Rate of responding participants (decrease of ≥ 3 points) at D42
Time frame: 42 days
Rate of responding participants (decrease of ≥ 5 points) at D21
Time frame: 21 days
Rate of responding participants (decrease of ≥ 5 points) at D42
Time frame: 42 days
Rate of participants in remission at D21
Time frame: 21 days
Rate of participants in remission at D42
Time frame: 42 days
Evolution of depressive symptoms through Hospital Anxiety and Depression Scale - Depression (HADS-D) during the study
Time frame: 42 days
Evolution of depressive symptoms through Hospital Anxiety and Depression Scale - Anxiety (HADS-A) during the study
Time frame: 42 days
Evolution of physician's general impression of the symptoms during the study
Time frame: 42 days
Evolution of physician's general impression of the symptoms evolution during the study
Time frame: 42 days
Evolution of patient's general impression of the symptoms evolution during the study
Time frame: 42 days
Adverse events
Time frame: 42 days
Evolution of patient's functional disability in his or her professional, social and family life during the study
Time frame: 42 days
Patient satisfaction with complementation at D21
Time frame: 21 days
Patient satisfaction with complementation at D42
Time frame: 42 days
Number of intercurrent visits
Time frame: 42 days
Concomitant drug use
Time frame: 42 days
Compliance at D21
Time frame: 21 days
Compliance at D42
Time frame: 42 days
Management prescribed or advised at the end of follow-up
Time frame: 42 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jul 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Dietary supplement in people with Psychological Well-being, run by Larena SAS at 1 site in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evolution of depressive symptoms through Hamilton Depression Scale (HAM-D) at the end of the study (time frame: 42 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jul 2025.