Status:
COMPLETED
Evaluation of the Effect of a Combination of Plants to Regulate Mood
Lead Sponsor:
Comercial Quimica Masso, S.A
Collaborating Sponsors:
Université Catholique de Louvain
Conditions:
Mood Regulation
Eligibility:
All Genders
18-75 years
Phase:
NA
Brief Summary
The aim of this study is to confirm by a randomized double-blind controlled study the interest of a combination of saffron (Saffr'Activ®) and scutellaria (Scutell'up®) on the regulation of mood.
Eligibility Criteria
Inclusion
- 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 mild to moderate symptoms;
- Participant with a recent episode of depression (less than 2 years), not managed by antidepressant or psychotherapeutic treatment;
- Participant with a current depressive disorder not requiring, in the investigator's opinion, the initiation of antidepressant medication;
- Provision of signed and dated informed consent form;
- Stated willingness to comply with all study procedures and availability for the duration of the study;
- French speaker.
Exclusion
- Participant with a depressive disorder of another nature or any other mental pathology (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 to inclusion) (neuroleptic, anxiolytic, hypnotic);
- Participant with a serious health problem for which the Investigator considers that it is not in the participant's interest to participate in the study;
- Participant using products containing piperine or millpertuis, or having a known effect on mood within the last 4 weeks;
- Pregnant or breastfeeding women, or those planning to become pregnant within the next 8 weeks;
- Participant with an allergy or contraindication to any component of the study drug;
- Participant unable to understand study information (mental or linguistic disability);
- Participant who is participating or has participated in the previous month in another clinical trial.
Key Trial Info
Start Date :
May 30 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 30 2024
Estimated Enrollment :
180 Patients enrolled
Trial Details
Trial ID
NCT06138470
Start Date
May 30 2022
End Date
September 30 2024
Last Update
January 29 2025
Active Locations (1)
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1
Université Catholique de Louvain, CICN
Ottignies-Louvain-la-Neuve, Belgium, 1348