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

N/ACompletedNCT05199545

Larena SAS126 enrolled

Overview

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).

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

Allocation

RANDOMIZED

Purpose

OTHER

Masking

QUADRUPLE

Enrollment

126

Conditions

Psychological Well-being

Interventions

Dietary supplementDIETARY_SUPPLEMENT

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

PlaceboOTHER

Placebo of the dietary supplement

Eligibility

Sex: ALLMin age: 18 YearsMax age: 75 Years

Medical Language ↔ Plain English

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 ;

Locations (1)

CICN - Université Catholique de Louvain

Louvain-la-Neuve, Belgium

Outcomes

Primary Outcomes

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

Time frame: 42 days

Secondary Outcomes

Evolution of depressive symptoms through HAM-D during the study

Evolution of score HAM-D between D0, D21 and D42

Time frame: 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

Time frame: 42 days

Rate of responding participants (decrease of ≥ 3 points) at D21

HAM-D score showing a decrease of ≥ 3 points compared to D0

Time frame: 21 days

Rate of responding participants (decrease of ≥ 3 points) at D42

HAM-D score showing a decrease of ≥ 3 points compared to D0

Time frame: 42 days

Rate of responding participants (decrease of ≥ 5 points) at D21

HAM-D score showing a decrease of ≥ 5 points compared to D0

Time frame: 21 days

Rate of responding participants (decrease of ≥ 5 points) at D42

HAM-D score showing a decrease of ≥ 5 points compared to D0

Time frame: 42 days

Rate of participants in remission at D21

score HAM-D ≤ 7

Data from ClinicalTrials.gov

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