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Completed

NCT Number: NCT06138470

Evaluation of the Effect of a Combination of Plants 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.

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Key information

Conditions

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Université Catholique de Louvain, CICN

Ottignies-Louvain-la-Neuve, 1348, Belgium

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Saffron extract

Dietary Supplement

Food supplements are taken during 6 weeks by healthy volunteers

Scutellaria baicalensis extract

Dietary Supplement

Food supplements are taken during 6 weeks by healthy volunteers

Saffron and Scutellaria baicalensis extract

Dietary Supplement

Food supplements are taken during 6 weeks by healthy volunteers

Placebo (Maltodextrin)

Dietary Supplement

Food supplements are taken during 6 weeks by healthy volunteers

Primary outcomes

  1. Evaluated mood regulation

    Time frame: 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 outcomes

  1. Evaluated mood regulation

    Time frame: 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.

  2. Evaluated mood regulation

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Comercial Quimica Masso, S.A

Industry

Collaborators

  • Université Catholique de Louvain

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2024
Study completion
2024
First posted
Nov 18, 2023
Registry last updated
Jan 29, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.