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

Last updated: January 28, 2025
Sponsor: Comercial Quimica Masso, S.A
Overall Status: Completed

Phase

N/A

Condition

Emotional Processing

Treatment

Scutellaria baicalensis extract

Saffron extract

Placebo (maltodextrin)

Clinical Study ID

NCT06138470
SAFFRUP
  • Ages 18-75
  • All Genders
  • Accepts Healthy Volunteers

Study 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.

Eligibility Criteria

Inclusion

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 mildto moderate symptoms;

  • Participant with a recent episode of depression (less than 2 years), not managed byantidepressant or psychotherapeutic treatment;

  • Participant with a current depressive disorder not requiring, in the investigator'sopinion, the initiation of antidepressant medication;

  • Provision of signed and dated informed consent form;

  • Stated willingness to comply with all study procedures and availability for theduration of the study;

  • French speaker.

Exclusion

Exclusion Criteria:

  • Participant with a depressive disorder of another nature or any other mentalpathology (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 toinclusion) (neuroleptic, anxiolytic, hypnotic);

  • Participant with a serious health problem for which the Investigator considers thatit is not in the participant's interest to participate in the study;

  • Participant using products containing piperine or millpertuis, or having a knowneffect on mood within the last 4 weeks;

  • Pregnant or breastfeeding women, or those planning to become pregnant within thenext 8 weeks;

  • Participant with an allergy or contraindication to any component of the study drug;

  • Participant unable to understand study information (mental or linguisticdisability);

  • Participant who is participating or has participated in the previous month inanother clinical trial.

Study Design

Total Participants: 180
Treatment Group(s): 4
Primary Treatment: Scutellaria baicalensis extract
Phase:
Study Start date:
May 30, 2022
Estimated Completion Date:
September 30, 2024

Connect with a study center

  • Université Catholique de Louvain, CICN

    Ottignies-Louvain-la-Neuve, 1348
    Belgium

    Site Not Available

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