Evaluation of the Effect of a Combination of Plants to Regulate Mood

Study Overview
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Brief Summary
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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.

Official Title
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Evaluation of the Effect of a Combination of Plants (Saffron and Scutellaria) to Regulate Mood

Conditions
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Mood Regulation

Intervention / Treatment
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* Dietary Supplement: Saffron extract
* Dietary Supplement: Scutellaria baicalensis extract
* Dietary Supplement: Saffron and Scutellaria baicalensis extract
* Dietary Supplement: Placebo (maltodextrin)


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Saffron extract<br> | Dietary Supplement: Saffron extract<br>* Food supplements are taken during 6 weeks by healthy volunteers<br>|
| Active Comparator: Scutellaria baicalensis extract<br> | Dietary Supplement: Scutellaria baicalensis extract<br>* Food supplements are taken during 6 weeks by healthy volunteers<br>|
| Active Comparator: Saffron and Scutellaria baicalensis extract<br> | Dietary Supplement: Saffron and Scutellaria baicalensis extract<br>* Food supplements are taken during 6 weeks by healthy volunteers<br>|
| Placebo Comparator: Placebo (maltodextrin)<br> | Dietary Supplement: Placebo (maltodextrin)<br>* Food supplements are taken during 6 weeks by healthy volunteers<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluated mood regulation | 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. | Baseline and 6 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluated mood regulation | Beck Inventory Depression (BDI) score. All items are scored on a 4-point scale, ranging from 0 to 3. | 3 and 6 weeks of intervention and after 2 weeks after the end of intervention | 
| Evaluated mood regulation | Hamilton depression rating scale (HAMD) score. HAMD is composed of 21 items. The scoring is based on the first 17 items. Eight items are scored on a 5-point scale, ranging from 0 = not present to 4 = severe. Nine are scored from 0-2. | after 3 and 6 weeks of intervention and after 2 weeks after the end of intervention |