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

Psychological Well-being Clinical Trial

— ROSADE  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05199545
• Other study ID #: PiL-Clin-ROSADE-021
• Status: Recruiting
• Phase: N/A
• Start date: April 26, 2022
• Est. completion date: May 1, 2024

Study information

• Verified date: January 2024
• Source: Larena SAS
• Contact: Samira Aït Abdellah
• Phone: (0)1 45 51 78 77
• Email: s.aitabdellah[@]pileje.com
• Is FDA regulated: No
• Study type: Interventional

Clinical 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).

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 126
• Est. completion date: May 1, 2024
• Est. primary completion date: May 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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 ;

Related Conditions & MeSH terms

• Psychological Well-being

Intervention

Dietary Supplement:
• Dietary supplement
Dietary supplement under study is based on Rhodiola rosea L. and Crocus sativus L. extracts

Other:
• Placebo
Placebo of the dietary supplement

Locations

Country	Name	City	State
Belgium	CICN - Université Catholique de Louvain	Louvain-la-Neuve

Sponsors (2)

Lead Sponsor	Collaborator
Larena SAS	Université Catholique de Louvain

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Evolution of depressive symptoms through HAM-D during the study	Evolution of score HAM-D between D0, D21 and D42	42 days
Secondary	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
Secondary	Rate of responding participants (decrease of = 3 points) at D21	HAM-D score showing a decrease of = 3 points compared to D0	21 days
Secondary	Rate of responding participants (decrease of = 3 points) at D42	HAM-D score showing a decrease of = 3 points compared to D0	42 days
Secondary	Rate of responding participants (decrease of = 5 points) at D21	HAM-D score showing a decrease of = 5 points compared to D0	21 days
Secondary	Rate of responding participants (decrease of = 5 points) at D42	HAM-D score showing a decrease of = 5 points compared to D0	42 days
Secondary	Rate of participants in remission at D21	score HAM-D = 7	21 days
Secondary	Rate of participants in remission at D42	score HAM-D = 7	42 days
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Adverse events	Number and type of adverse events	42 days
Secondary	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
Secondary	Patient satisfaction with complementation at D21	5-point Likert scale (minimum = 1 and maximum = 5) higher score means a better satisfaction	21 days
Secondary	Patient satisfaction with complementation at D42	5-point Likert scale	42 days
Secondary	Number of intercurrent visits	Number of intercurrent visits	42 days
Secondary	Concomitant drug use	Number and type of concomitant drugs	42 days
Secondary	Compliance at D21	Counting of therapeutic units at D21	21 days
Secondary	Compliance at D42	Counting of therapeutic units at D42	42 days
Secondary	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