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

Not Applicable

Completed

• Conditions: Mood Regulation
• Interventions: Dietary Supplement: Placebo (maltodextrin); Dietary Supplement: Saffron and Scutellaria baicalensis extract; Dietary Supplement: Scutellaria baicalensis extract; Dietary Supplement: Saffron extract

• Registration Number: NCT06138470
• Lead Sponsor: Comercial Quimica Masso, S.A

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2022-05-30
• Study First Submitted: 2023-11-14
• Study First Submitted QC: 2023-11-17
• Study First Posted: 2023-11-18
• Primary Completion: 2024-07-30
• Study Completion: 2024-09-30
• Status Verified: 2025-01
• Last Update Submitted: 2025-01-28
• Last Update Posted: 2025-01-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 180

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo (maltodextrin)	Placebo (maltodextrin)	-
Saffron and Scutellaria baicalensis extract	Saffron and Scutellaria baicalensis extract	-
Scutellaria baicalensis extract	Scutellaria baicalensis extract	-
Saffron extract	Saffron extract	-

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
Evaluated mood regulation	after 3 and 6 weeks of intervention and after 2 weeks after the end of intervention	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.

Trial Locations

Locations (1)

Université Catholique de Louvain, CICN; 🇧🇪 Ottignies-Louvain-la-Neuve, Belgium