Phase
Condition
Emotional Processing
Treatment
Scutellaria baicalensis extract
Saffron extract
Placebo (maltodextrin)
Clinical Study ID
Ages 18-75 All Genders Accepts Healthy Volunteers
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Woman or man, aged of 18 to 75 years;
Participant presenting a depressive episode, according to the DSM-5 definition;
Participant presenting a BDI ≥ 14 and ≤ 28 at the inclusion, corresponding to mildto moderate symptoms;
Participant with a recent episode of depression (less than 2 years), not managed byantidepressant or psychotherapeutic treatment;
Participant with a current depressive disorder not requiring, in the investigator'sopinion, the initiation of antidepressant medication;
Provision of signed and dated informed consent form;
Stated willingness to comply with all study procedures and availability for theduration of the study;
French speaker.
Exclusion
Exclusion Criteria:
Participant with a depressive disorder of another nature or any other mentalpathology (schizophrenia, bipolarity, addiction to alcohol or drugs...);
Participant at risk of suicide (determined by the Investigator, or HAMD item 3 score > 2) or having made a suicide attempt in the last 5 years;
Participant with depression for more than 2 years;
Participant undergoing psychotropic treatment (current or in the month prior toinclusion) (neuroleptic, anxiolytic, hypnotic);
Participant with a serious health problem for which the Investigator considers thatit is not in the participant's interest to participate in the study;
Participant using products containing piperine or millpertuis, or having a knowneffect on mood within the last 4 weeks;
Pregnant or breastfeeding women, or those planning to become pregnant within thenext 8 weeks;
Participant with an allergy or contraindication to any component of the study drug;
Participant unable to understand study information (mental or linguisticdisability);
Participant who is participating or has participated in the previous month inanother clinical trial.
Study Design
Connect with a study center
Université Catholique de Louvain, CICN
Ottignies-Louvain-la-Neuve, 1348
BelgiumSite Not Available
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