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

Larena SAS

Status: Completed

Conditions: Psychological Well-being

Treatments: Other: Placebo; Dietary Supplement: Dietary supplement

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT05199545

PiL-Clin-ROSADE-021

Details and patient eligibility

About

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).

Full 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.

Enrollment: 126 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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 ;

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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126 participants in 2 patient groups, including a placebo group

Dietary supplement group

Experimental group

Description:

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.

Treatment:

Dietary Supplement: Dietary supplement

Placebo group

Placebo Comparator group

Description:

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.

Treatment:

Other: Placebo