Evaluation of the Effect of a Combination of Plants to Regulate Mood
NCT ID: NCT06138470
Last Updated: 2025-01-29
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
180 participants
INTERVENTIONAL
2022-05-30
2024-09-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
OTHER
QUADRUPLE
Study Groups
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Saffron extract
Saffron extract
Food supplements are taken during 6 weeks by healthy volunteers
Scutellaria baicalensis extract
Scutellaria baicalensis extract
Food supplements are taken during 6 weeks by healthy volunteers
Saffron and Scutellaria baicalensis extract
Saffron and Scutellaria baicalensis extract
Food supplements are taken during 6 weeks by healthy volunteers
Placebo (maltodextrin)
Placebo (maltodextrin)
Food supplements are taken during 6 weeks by healthy volunteers
Interventions
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Saffron extract
Food supplements are taken during 6 weeks by healthy volunteers
Scutellaria baicalensis extract
Food supplements are taken during 6 weeks by healthy volunteers
Saffron and Scutellaria baicalensis extract
Food supplements are taken during 6 weeks by healthy volunteers
Placebo (maltodextrin)
Food supplements are taken during 6 weeks by healthy volunteers
Eligibility Criteria
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Inclusion Criteria
* 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 Criteria
* 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.
18 Years
75 Years
ALL
Yes
Sponsors
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Université Catholique de Louvain
OTHER
Comercial Quimica Masso, S.A
INDUSTRY
Responsible Party
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Principal Investigators
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Valérie Dormal, PhD
Role: STUDY_CHAIR
Université Catholique de Louvain
Louise Deldicque, Pr
Role: STUDY_DIRECTOR
Université Catholique de Louvain
Laurent Simar, Dr
Role: PRINCIPAL_INVESTIGATOR
Université Catholique de Louvain
Locations
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Université Catholique de Louvain, CICN
Ottignies-Louvain-la-Neuve, , Belgium
Countries
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Other Identifiers
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SAFFRUP
Identifier Type: -
Identifier Source: org_study_id
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