Plant-based supplement for improving psychological well-being

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

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

Study contacts

• Study coordinator: Samira Aït Abdellah
• Email: s.aitabdellah@pileje.com
• Phone: (0)1 45 51 78 77

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.