Plant-based supplement for improving psychological well-being

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

This study is testing whether a plant-based supplement can help people with moderate depression feel better compared to a placebo.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 126 (estimated)
• Ages: 18 Years to 75 Years
• Sex: All
• Sponsor: Larena SAS (Industry-sponsored)
• Locations: 1 site (Louvain-la-Neuve)
• Trial ID: NCT05199545 on ClinicalTrials.gov

What this trial studies

This study aims to evaluate the effectiveness of a dietary supplement made from plant extracts in improving psychological well-being in patients experiencing a moderate depressive episode. It is a randomized, double-blind, placebo-controlled trial where participants will be assigned to receive either the supplement or a placebo for six weeks. Patients will be monitored through three visits to assess changes in depressive symptoms using standardized scales. The goal is to demonstrate that the plant-based treatment is superior to placebo in alleviating moderate depressive symptoms.

Who should consider this trial

Good fit: Ideal candidates are French-speaking adults aged 18 to 75 with a recent moderate depressive episode not currently treated with antidepressants.

Not a fit: Patients with other mental health disorders, those at risk of suicide, or those who have been depressed for more than six months may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide a natural alternative for improving psychological well-being in patients with moderate depression.

How similar studies have performed: While there is ongoing interest in phytotherapy for mental health, this specific approach is relatively novel and has not been extensively tested in similar studies.

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 ;

Where this trial is running

Louvain-la-Neuve

• CICN - Université Catholique de Louvain — Louvain-la-Neuve, Belgium (Recruiting)

Study contacts

• Study coordinator: Samira Aït Abdellah

Conditions Psychological Well-being