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

Evaluation of the Effect of a Combination of Plants (saffron and Scutellaria) to Regulate Mood

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.

Study Overview

• Status: Completed
• Conditions: Mood Regulation
• Intervention / Treatment: Dietary supplement: Saffron extract; Dietary supplement: Scutellaria baicalensis extract; Dietary supplement: Saffron and Scutellaria baicalensis extract; Dietary supplement: Placebo (maltodextrin)

• Study Type: Interventional
• Enrollment (Actual): 180
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Belgium
  • Ottignies-Louvain-la-Neuve, Belgium, 1348
    • Université Catholique de Louvain, CICN

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Saffron extract	Dietary supplement: Saffron extract; Food supplements are taken during 6 weeks by healthy volunteers
Active Comparator: Scutellaria baicalensis extract	Dietary supplement: Scutellaria baicalensis extract; Food supplements are taken during 6 weeks by healthy volunteers
Active Comparator: Saffron and Scutellaria baicalensis extract	Dietary supplement: Saffron and Scutellaria baicalensis extract; Food supplements are taken during 6 weeks by healthy volunteers
Placebo Comparator: Placebo (maltodextrin)	Dietary supplement: Placebo (maltodextrin); Food supplements are taken during 6 weeks by healthy volunteers

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Comercial Quimica Masso, S.A
• Collaborators: Université Catholique de Louvain
• Investigators: Study Chair: Valérie Dormal, PhD, Université Catholique de Louvain; Study Director: Louise Deldicque, Pr, Université Catholique de Louvain; Principal Investigator: Laurent Simar, Dr, Université Catholique de Louvain

Study record dates

Study Major Dates

• Study Start (Actual): May 30, 2022
• Primary Completion (Actual): July 30, 2024
• Study Completion (Actual): September 30, 2024

Study Registration Dates

• First Submitted: November 14, 2023
• First Submitted That Met QC Criteria: November 17, 2023
• First Posted (Actual): November 18, 2023

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: January 28, 2025
• Last Verified: January 1, 2025

More Information

Terms related to this study

• Other Study ID Numbers: SAFFRUP

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No