Mood Regulation
Conditions
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.
Interventions
DIETARY_SUPPLEMENTSaffron extract
Food supplements are taken during 6 weeks by healthy volunteers
DIETARY_SUPPLEMENTScutellaria baicalensis extract
Food supplements are taken during 6 weeks by healthy volunteers
DIETARY_SUPPLEMENTSaffron and Scutellaria baicalensis extract
Food supplements are taken during 6 weeks by healthy volunteers
DIETARY_SUPPLEMENTPlacebo (maltodextrin)
Food supplements are taken during 6 weeks by healthy volunteers
Sponsors
Université Catholique de Louvain
Comercial Quimica Masso, S.A
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
Yes
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 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 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Evaluated mood regulation | Baseline and 6 weeks | observe a difference of the Beck Inventory Depression (BDI) score (adjusted for baseline), after 6 weeks of supplementation. All items are scored on a 4-point scale, ranging from 0 to 3. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Evaluated mood regulation | 3 and 6 weeks of intervention and after 2 weeks after the end of intervention | Beck Inventory Depression (BDI) score. All items are scored on a 4-point scale, ranging from 0 to 3. |
Countries
Belgium
Outcome results
None listed