Phase
Condition
N/ATreatment
Dietary supplement
Placebo
Clinical Study ID
Ages 18-75 All Genders
Study Summary
Eligibility Criteria
Inclusion
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 orpsychotherapeutic treatment ;
Depressive disorder not requiring, in the opinion of the investigator, initiation ofantidepressant drug therapy ;
Patient able to understand the study information, read the information leaflet, andwilling to sign the consent form ;
French speaking patient.
Exclusion
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) orhaving 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 knowneffect 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 productunder study (rhodiola or saffron) ;
Patient unable to understand information related to the study (mental or linguisticdisability) ;
Patient participating or having participated in the previous 3 months in anotherclinical trial ;
Study Design
Study Description
Connect with a study center
CICN - Université Catholique de Louvain
Louvain-la-Neuve,
BelgiumSite Not Available
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