Mood RegulationNCT06138470

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

A study testing Saffron extract, Scutellaria baicalensis extract and Saffron and Scutellaria baicalensis extract in people with Mood Regulation, run by Comercial Quimica Masso, S.A at 1 site in Belgium.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial 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. Read more about this study

Who is it for?: Ages 18 to 75 yearsHealthy volunteers can take part
Conditions the study is for: Mood Regulation
What is being tested?: Saffron extract, Scutellaria baicalensis extract and Saffron and Scutellaria baicalensis extract
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 180 participants
Where: 1 siteBelgium
Study dates: 30 May 2022to 30 Sep 2024
Phase: Interventional
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 75 years
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

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.

Who cannot join

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;

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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 locations and contacts

1 site in 1 country.

Belgium1 site

Université Catholique de Louvain, CICN
Ottignies-Louvain-la-Neuve, 1348

Other trials in Belgium

About this study

Official title: Evaluation of the Effect of a Combination of Plants (saffron and Scutellaria) 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.

Conditions: Mood Regulation
Being tested: Saffron extract, Scutellaria baicalensis extract, Saffron and Scutellaria baicalensis extract, Placebo (maltodextrin)

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Saffron extractDietary supplement
Food supplements are taken during 6 weeks by healthy volunteers
Scutellaria baicalensis extractDietary supplement
Food supplements are taken during 6 weeks by healthy volunteers
Saffron and Scutellaria baicalensis extractDietary 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

Study groups in NCT06138470
Study group	Role	What they receive
Saffron extract	Active comparator	Not described Receives: Dietary Supplement: Saffron extract
Scutellaria baicalensis extract	Active comparator	Not described Receives: Dietary Supplement: Scutellaria baicalensis extract
Saffron and Scutellaria baicalensis extract	Active comparator	Not described Receives: Dietary Supplement: Saffron and Scutellaria baicalensis extract
Placebo (maltodextrin)	Placebo comparator	Not described Receives: Dietary Supplement: Placebo (maltodextrin)

What is being measured

The primary outcome is the main question the study is designed to answer.

Evaluated mood regulation
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.
Measured: Baseline and 6 weeks

Secondary outcomes (2)

Evaluated mood regulation
Beck Inventory Depression (BDI) score. All items are scored on a 4-point scale, ranging from 0 to 3.
Measured: 3 and 6 weeks of intervention and after 2 weeks after the end of intervention
Evaluated mood regulation
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.
Measured: after 3 and 6 weeks of intervention and after 2 weeks after the end of intervention

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

30 May 202230 Sep 2024

First posted18 Nov 2023
Study start30 May 2022
Primary completion30 Jul 2024
Study completion30 Sep 2024

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Mood RegulationStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Other
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 180 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT06138470
Sponsor's protocol ID: SAFFRUP
Status last verified: Jan 2025
First submitted: 14 Nov 2023
Last updated: 29 Jan 2025
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Psychophysiological Responses to Six Single-Session Self-Regulation Interventions in a Female Adult With ADHD and Stabilized Bipolar Disorder
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A Mobile App to Support Mood, Daily Routines and Medication Adherence in Adults With Severe Mental Illness
Severe Mental Illness, Bipolar Disorder
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All Mood Regulation trials

Study at a glance

From the registry record, last updated by the sponsor on 29 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Evaluation of the Effect of a Combination of Plants (saffron and Scutellaria) to Regulate Mood
ClinicalTrials.gov ID: NCT06138470
Acronym / sponsor ID: SAFFRUP
Conditions: Mood Regulation
Study type: Interventional
Recruitment status: Completed
Enrolment: 180 participants (actual)
Lead sponsor: Comercial Quimica Masso, S.AIndustry (pharma, biotech, devices)
Collaborators: Université Catholique de Louvain
Study start: 30 May 2022 (actual)
Primary completion: 30 Jul 2024 (actual)
Study completion: 30 Sep 2024 (actual)
First posted: 18 Nov 2023 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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.

Study design

Primary purpose: Other
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 4

Arm	Type	Receives
Saffron extract	Active comparator	Dietary Supplement: Saffron extract
Scutellaria baicalensis extract	Active comparator	Dietary Supplement: Scutellaria baicalensis extract
Saffron and Scutellaria baicalensis extract	Active comparator	Dietary Supplement: Saffron and Scutellaria baicalensis extract
Placebo (maltodextrin)	Placebo comparator	Dietary Supplement: Placebo (maltodextrin)

Who may qualify

Ages: 18 to 75 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (8 listed)

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;

Key exclusion criteria (10 listed)

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;

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Saffron extractFood supplements are taken during 6 weeks by healthy volunteers	Dietary supplement	Saffron extract
Scutellaria baicalensis extractFood supplements are taken during 6 weeks by healthy volunteers	Dietary supplement	Scutellaria baicalensis extract
Saffron and Scutellaria baicalensis extractFood supplements are taken during 6 weeks by healthy volunteers	Dietary supplement	Saffron and Scutellaria baicalensis extract
Placebo (maltodextrin)Food supplements are taken during 6 weeks by healthy volunteers	Dietary supplement	Placebo (maltodextrin)

Primary outcome

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.

2 secondary outcomes

Evaluated mood regulation
Time frame: 3 and 6 weeks of intervention and after 2 weeks after the end of intervention
Evaluated mood regulation
Time frame: after 3 and 6 weeks of intervention and after 2 weeks after the end of intervention

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 29 Jan 2025.
Individual participant dataSharing planned: No

Related trials for Mood Regulation

Not yet recruiting
Preventive and Personalized Digital Emotion Regulation Skills Intervention to Reduce Depression and Anxiety in Youths With Adverse Childhood Experiences
Adverse Childhood Experience, Depression / Major Depressive Disorder
Recruiting
Psychophysiological Responses to Six Single-Session Self-Regulation Interventions in a Female Adult With ADHD and Stabilized Bipolar Disorder
ADHD - Attention Deficit Disorder With Hyperactivity, Bipolar Affective Disorder; Remission in
Recruiting
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Major Depressive Disorder
Not yet recruiting
A Mobile App to Support Mood, Daily Routines and Medication Adherence in Adults With Severe Mental Illness
Severe Mental Illness, Bipolar Disorder
Recruiting
Perfectionism and Daily Coping and Emotion Regulation Processes: A Trial of Two Explanatory Feedback Interventions
Perfectionism, Psychological Well-being

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Valérie Dormal, PhD study chair

Université Catholique de Louvain

Louise Deldicque, Pr study director

Université Catholique de Louvain

Laurent Simar, Dr principal investigator

Université Catholique de Louvain

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 29 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Evaluated mood regulation (time frame: Baseline and 6 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06138470.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jan 2025.