Clinical trial NCT06138470: Evaluation of the Effect of a Combination of Plants to Regulate Mood
Official title: Evaluation of the Effect of a Combination of Plants (saffron and Scutellaria) to Regulate Mood
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Mood Regulation
Lead sponsor: Comercial Quimica Masso, S.A
Sponsor class: INDUSTRY
Collaborators: name: Université Catholique de Louvain
First posted: 2023-11-18
Enrollment: 180
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Evaluated mood regulation
timeFrame: Baseline and 6 weeks
Secondary outcomes:
measure: Evaluated mood regulation
timeFrame: 3 and 6 weeks of intervention and after 2 weeks after the end of intervention
measure: Evaluated mood regulation
timeFrame: after 3 and 6 weeks of intervention and after 2 weeks after the end of intervention
Other outcomes:
Locations:
city: Ottignies-Louvain-la-Neuve
country: Belgium
facility: Université Catholique de Louvain, CICN
Study officials:
affiliation: Université Catholique de Louvain
name: Valérie Dormal, PhD
role: STUDY_CHAIR
affiliation: Université Catholique de Louvain
name: Louise Deldicque, Pr
role: STUDY_DIRECTOR
affiliation: Université Catholique de Louvain
name: Laurent Simar, Dr
role: PRINCIPAL_INVESTIGATOR
References: