Clinical trial NCT05199545: Efficacy Study in Phytotherapy of an Association of Plants in the Improvement of Psychological Well-being
Official title: Efficacy Study in Phytotherapy of an Association of Plants in the Improvement of Psychological Well-being
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Psychological Well-being
Lead sponsor: Larena SAS
Sponsor class: INDUSTRY
Collaborators: name: Université Catholique de Louvain
First posted: 2022-01-20
Enrollment: 126
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief 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).

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.

Eligibility criteria: 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 ;

Primary outcomes:
measure: Evolution of depressive symptoms through Hamilton Depression Scale (HAM-D) at the end of the study
timeFrame: 42 days
Secondary outcomes:
measure: Evolution of depressive symptoms through HAM-D during the study
timeFrame: 42 days
measure: Evolution of depressive symptoms through HAM-D sub-scores during the study
timeFrame: 42 days
measure: Rate of responding participants (decrease of ≥ 3 points) at D21
timeFrame: 21 days
measure: Rate of responding participants (decrease of ≥ 3 points) at D42
timeFrame: 42 days
measure: Rate of responding participants (decrease of ≥ 5 points) at D21
timeFrame: 21 days
measure: Rate of responding participants (decrease of ≥ 5 points) at D42
timeFrame: 42 days
measure: Rate of participants in remission at D21
timeFrame: 21 days
measure: Rate of participants in remission at D42
timeFrame: 42 days
measure: Evolution of depressive symptoms through Hospital Anxiety and Depression Scale - Depression (HADS-D) during the study
timeFrame: 42 days
measure: Evolution of depressive symptoms through Hospital Anxiety and Depression Scale - Anxiety (HADS-A) during the study
timeFrame: 42 days
measure: Evolution of physician's general impression of the symptoms during the study
timeFrame: 42 days
measure: Evolution of physician's general impression of the symptoms evolution during the study
timeFrame: 42 days
measure: Evolution of patient's general impression of the symptoms evolution during the study
timeFrame: 42 days
measure: Adverse events
timeFrame: 42 days
measure: Evolution of patient's functional disability in his or her professional, social and family life during the study
timeFrame: 42 days
measure: Patient satisfaction with complementation at D21
timeFrame: 21 days
measure: Patient satisfaction with complementation at D42
timeFrame: 42 days
measure: Number of intercurrent visits
timeFrame: 42 days
measure: Concomitant drug use
timeFrame: 42 days
measure: Compliance at D21
timeFrame: 21 days
measure: Compliance at D42
timeFrame: 42 days
measure: Management prescribed or advised at the end of follow-up
timeFrame: 42 days
Other outcomes:
Locations:
city: Louvain-la-Neuve
country: Belgium
facility: CICN - Université Catholique de Louvain
Study officials:
References: