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

Comercial Quimica Masso

Status: Completed

Conditions: Mood Regulation

Treatments: Dietary Supplement: Placebo (maltodextrin); Dietary Supplement: Saffron and Scutellaria baicalensis extract; Dietary Supplement: Scutellaria baicalensis extract; Dietary Supplement: Saffron extract

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT06138470

SAFFRUP

Details and patient eligibility

About

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.

Enrollment: 180 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

---

180 participants in 4 patient groups, including a placebo group

Saffron extract

Active Comparator group

Treatment:

Dietary Supplement: Saffron extract

Scutellaria baicalensis extract

Active Comparator group

Treatment:

Dietary Supplement: Scutellaria baicalensis extract

Saffron and Scutellaria baicalensis extract

Active Comparator group

Treatment:

Dietary Supplement: Saffron and Scutellaria baicalensis extract

Placebo (maltodextrin)

Placebo Comparator group

Treatment:

Dietary Supplement: Placebo (maltodextrin)