AnhedoniaMOOD5NCT05306093
Depressed Mood and Anhedonia in Healthy Adults
A study testing Nutraceutical and Maltodextrin in people with Anhedonia and Depressed Mood, run by Institut Pasteur de Lille at 1 site in France.
Trial summary
The aim of this study is to evaluate the effect of nutraceutical supplement on depressed mood and anhedonia in volunteers after 8 weeks of consumption. Read more about this study
- Who is it for?
- Ages 20 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Anhedonia, Depressed Mood
- What is being tested?
- Nutraceutical and Maltodextrin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 94 participants
- Where
- 1 siteFrance
- Study dates
- 7 Jan 2022to 1 Sep 2022
- 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 20 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Adults aged between 20 and 65 years (limits included);
- Body Mass Index (BMI) ≥19 and < 30 kg/m²;
- Considered healthy based on their medical history and clinical examination;
- Subjects self-reporting anhedonia based on SHAPS questionnaire. Score ≥ 3 allows the inclusion;
- Subjects with depressive mood disturbance based on POMS depression subscale. Score ≥ 4 allows the inclusion;
- Able and willing to participate to the study by complying with the protocol procedures as evidenced by his dated and signed informed consent form;
- Affiliated with a social security scheme;
- Agreeing to be registered on the national file of the volunteers in biomedical research.
Who cannot join
- Suffer from mental health other than mild depressive or anxiety symptoms as measured by the Patient Health Questionnaire (PHQ-9). Volunteers with PHQ-9 score >14 could not be included;
- Having suicidal thoughts: score ≥1 at the item 9 of the PHQ-9;
- Diagnosis of medical or psychiatric conditions including (but not limited to):
- psychiatric disorder (other than mild-to-moderate depression symptoms, anhedonia or anxiety),
- neurological disease (Parkinson's, Alzheimer's disease, intracranial haemorrhage, head or brain injury),
- cancer/malignancy,
Show all 25Show fewer
- cardiovascular disease (other than hypertension),
- Immunological disease,
- endocrine disease (including diabetes or thyroid diseases, Chronic kidney disease, hematological abnormalities);
- Smokers (more than 5 cigarettes per day);
- Uncontrolled hypertension with medication (SBP ≥ 160mmHg or DBP ≥ 100 mmHg) or without medication (SBP ≥ 140mmHg or DBP ≥ 90 mmHg);
- Taking drugs (anxiolytics, antidepressants, antihistamine drug more than 7 day/month) known to have an impact on mental health in the month preceding inclusion and / or likely to consume them during the study and/or Illicit drug;
- Undergoing a psychotherapy in the month preceding inclusion or during the study;
- Consuming more than 3 standard drinks of alcoholic beverage daily;
- Weight change above 10% body weight within the past 6 months before inclusion;
- Currently under prescribed diet regimen, whatever the reason;
- Consuming foods supplement known to have an influence on mental health in the month preceding the inclusion and / or likely to take during the study;
- Consuming more than 50g of chocolate/day;
- For females: Pregnant or planning pregnancy during the study or breastfeeding;
- Any intolerance or allergy documented or suspected to one of the components of the study products;
- Taking part in another clinical trial or being in the exclusion period of a previous clinical trial;
- Subject who would receive more than 4500 euros as indemnities for his participation in biomedical research within the 12 last months, including the indemnities for the present study;
- Under legal protection (guardianship, wardship) or deprived from his rights following administrative or judicial decision;
- Presenting a psychological or linguistic incapability to sign the informed consent and to answer the study questionnaires
- Any other condition which in the investigator's opinion may adversely affect the subject's ability to complete the study or its measures or which may pose significant risk to the subject.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Chronic Effect of a Standardized Saffron Extract on Depressed Mood and Anhedonia in Healthy Adults. A Randomized Controlled Double-blind Clinical Trial.
The aim of this study is to evaluate the effect of nutraceutical supplement on depressed mood and anhedonia in volunteers after 8 weeks of consumption.
- Conditions
- Anhedonia, Depressed Mood
- Being tested
- Nutraceutical, Maltodextrin
- Keywords
- saffron extract
- Medical subject headings
- Anhedonia, Consciousness Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NutraceuticalDietary supplement
Food supplements are consumed during 8 weeks by healthy volunteers
MaltodextrinDietary supplement
Food supplements are consumed during 8 weeks by healthy volunteers
| Study group | Role | What they receive |
|---|---|---|
| Nutraceutical | Experimental | Daily, 2 dietary supplements will be taken orally with some water, the first one during the breakfast and the second one during the dinner.
Dietary supplements in capsule form Receives: Dietary Supplement: Nutraceutical |
| Maltodextrin | Placebo comparator | Daily, 2 dietary supplements will be taken orally with some water, the first one during the breakfast and the second one during the dinner.
Dietary supplements in capsule form Receives: Dietary Supplement: Maltodextrin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mood disturbance evaluated by the Profile Of Mood States (POMS) total score
The POMS is a self-reported validated questionnaire assessing six mood subscales: tension-anxiety, depression, anger-hostility, vigor, fatigue, and confusion. In our study, a score on POMS depression subscale < 4 does not allow the inclusion.
Measured: Baseline (V1)
Mood disturbance evaluated by the Profile Of Mood States (POMS) total score
The POMS is a self-reported validated questionnaire assessing six mood subscales: tension-anxiety, depression, anger-hostility, vigor, fatigue, and confusion. In our study, a score on POMS depression subscale < 4 does not allow the inclusion.
Measured: at 2 weeks
Mood disturbance evaluated by the Profile Of Mood States (POMS) total score
The POMS is a self-reported validated questionnaire assessing six mood subscales: tension-anxiety, depression, anger-hostility, vigor, fatigue, and confusion. In our study, a score on POMS depression subscale < 4 does not allow the inclusion.
Measured: at 4 weeks (V2)
Mood disturbance evaluated by the Profile Of Mood States (POMS) total score
The POMS is a self-reported validated questionnaire assessing six mood subscales: tension-anxiety, depression, anger-hostility, vigor, fatigue, and confusion. In our study, a score on POMS depression subscale < 4 does not allow the inclusion.
Measured: at 6 weeks
Mood disturbance evaluated by the Profile Of Mood States (POMS) total score
The POMS is a self-reported validated questionnaire assessing six mood subscales: tension-anxiety, depression, anger-hostility, vigor, fatigue, and confusion. In our study, a score on POMS depression subscale < 4 does not allow the inclusion.
Measured: at 8 weeks (V3)
Secondary outcomes (5)
Tension, anger, vigour, fatigue and confusion evaluated by the five POMS sub-scores
The POMS is a self-reported validated questionnaire assessing six mood subscales: tension-anxiety, depression, anger-hostility, vigor, fatigue, and confusion.
Measured: Baseline (V1) and 1st month (4 weeks (V2)) and between baseline and the end of the study (8 weeks (V3))
Depression level evaluated by the Center of Epidemiologic Studies Depression scale (CES-D) score
This validated self-reported questionnaire measures levels of depressive symptomatology, with special emphasis on the affective components and depressed mood.
Measured: Baseline (V1) and each evaluation (at 1 week, 2 weeks, 3 weeks, 4 weeks (V2), 5 weeks, 6 weeks, 7 weeks and the end of the study : 8 weeks (V3))
Stress, spleep, anxiety, sadness, energy feeling, attention to others and desire to do things evaluated by Visual Analogic Scales (VAS) score
The visual analog scales will be completed by the subjects at V1 and 2 times a week until 8 weeks. Eight dimensions are observed : stress, spleep, anxiety, happiness, energy feeling, irritability, motivation and pleasure.
Score 0 to 10.
Measured: Baseline (V1) and each week evaluation (1 week, 2 weeks, 3 weeks, 4 weeks (V2), 5 weeks, 6 weeks, 7 weeks and the end of the study : 8 weeks (V3))
Pleasure feeling evaluated by the Snaith-Hamilton Pleasure Scale (SHAPS) score
The Snaith-Hamilton Pleasure Scale (SHAPS) score is a 14-item self-reported validated questionnaire evaluating the pleasure. It covers four domains of hedonic experience: interest/pastimes, social interaction, sensory experience and food/drink.
A total score can be calculated by adding the responses to each question, ranging from 0 (no anhedonia) to 14 (complete anhedonia).
Measured: Baseline (V1) and each evaluation (2 weeks, 4 weeks (V2), 6 weeks and 8 weeks (V3)
Quality of life evaluated by the Multicultural Quality of Life Index (MQLI)
This validated self-reported questionnaire is composed of 10 items which cover key aspects of the quality of life, from physical well-being to spiritual fulfilment.
Measured: Baseline (V1) and 1st month (4 weeks (V2)) and between baseline and the end of the study (8 weeks (V3))
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Mar 2022
- Study start7 Jan 2022
- Primary completion1 Sep 2022
- Study completion1 Sep 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AnhedoniaStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 94 participants (actual)
Sponsor and investigators
- Lead sponsor
- Institut Pasteur de Lille
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jean-Michel Lecerf, Institut Pasteur de Lille
- Investigators
- Zakaria NAFLI, MD, Principal investigator, CEN Experimental
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05306093
- Sponsor's protocol ID
- 2021-A02123-38
- Acronym
- MOOD5
- Status last verified
- Sep 2022
- First submitted
- 15 Feb 2022
- Last updated
- 7 Sep 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Chronic Effect of a Standardized Saffron Extract on Depressed Mood and Anhedonia in Healthy Adults. A Randomized Controlled Double-blind Clinical Trial.
- ClinicalTrials.gov ID
- NCT05306093
- Acronym / sponsor ID
- MOOD5 / 2021-A02123-38
- Conditions
- Anhedonia, Depressed Mood
- Keywords
- saffron extract
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 94 participants (actual)
- Lead sponsor
- Institut Pasteur de LilleUniversity, hospital or other
- Study start
- 7 Jan 2022 (actual)
- Primary completion
- 1 Sep 2022 (actual)
- Study completion
- 1 Sep 2022 (actual)
- First posted
- 31 Mar 2022 (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 evaluate the effect of nutraceutical supplement on depressed mood and anhedonia in volunteers after 8 weeks of consumption.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Nutraceutical | Experimental | Dietary Supplement: NutraceuticalDaily, 2 dietary supplements will be taken orally with some water, the first one during the breakfast and the second one during the dinner. Dietary supplements in capsule form |
| Maltodextrin | Placebo comparator | Dietary Supplement: MaltodextrinDaily, 2 dietary supplements will be taken orally with some water, the first one during the breakfast and the second one during the dinner. Dietary supplements in capsule form |
Who may qualify
- Ages
- 20 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Adults aged between 20 and 65 years (limits included);
- Body Mass Index (BMI) ≥19 and < 30 kg/m²;
- Considered healthy based on their medical history and clinical examination;
- Subjects self-reporting anhedonia based on SHAPS questionnaire. Score ≥ 3 allows the inclusion;
- Subjects with depressive mood disturbance based on POMS depression subscale. Score ≥ 4 allows the inclusion;
Key exclusion criteria (25 listed)
- Suffer from mental health other than mild depressive or anxiety symptoms as measured by the Patient Health Questionnaire (PHQ-9). Volunteers with PHQ-9 score >14 could not be included;
- Having suicidal thoughts: score ≥1 at the item 9 of the PHQ-9;
- Diagnosis of medical or psychiatric conditions including (but not limited to):
- Smokers (more than 5 cigarettes per day);
- Uncontrolled hypertension with medication (SBP ≥ 160mmHg or DBP ≥ 100 mmHg) or without medication (SBP ≥ 140mmHg or DBP ≥ 90 mmHg);
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 |
|---|---|---|
| NutraceuticalFood supplements are consumed during 8 weeks by healthy volunteers | Dietary supplement | Nutraceutical |
| MaltodextrinFood supplements are consumed during 8 weeks by healthy volunteers | Dietary supplement | Maltodextrin |
Primary outcome
Mood disturbance evaluated by the Profile Of Mood States (POMS) total score
Time frame: Baseline (V1)
The POMS is a self-reported validated questionnaire assessing six mood subscales: tension-anxiety, depression, anger-hostility, vigor, fatigue, and confusion. In our study, a score on POMS depression subscale < 4 does not allow the inclusion.
Mood disturbance evaluated by the Profile Of Mood States (POMS) total score
Time frame: at 2 weeks
The POMS is a self-reported validated questionnaire assessing six mood subscales: tension-anxiety, depression, anger-hostility, vigor, fatigue, and confusion. In our study, a score on POMS depression subscale < 4 does not allow the inclusion.
Mood disturbance evaluated by the Profile Of Mood States (POMS) total score
Time frame: at 4 weeks (V2)
The POMS is a self-reported validated questionnaire assessing six mood subscales: tension-anxiety, depression, anger-hostility, vigor, fatigue, and confusion. In our study, a score on POMS depression subscale < 4 does not allow the inclusion.
Mood disturbance evaluated by the Profile Of Mood States (POMS) total score
Time frame: at 6 weeks
The POMS is a self-reported validated questionnaire assessing six mood subscales: tension-anxiety, depression, anger-hostility, vigor, fatigue, and confusion. In our study, a score on POMS depression subscale < 4 does not allow the inclusion.
Mood disturbance evaluated by the Profile Of Mood States (POMS) total score
Time frame: at 8 weeks (V3)
The POMS is a self-reported validated questionnaire assessing six mood subscales: tension-anxiety, depression, anger-hostility, vigor, fatigue, and confusion. In our study, a score on POMS depression subscale < 4 does not allow the inclusion.
5 secondary outcomes
Tension, anger, vigour, fatigue and confusion evaluated by the five POMS sub-scores
Time frame: Baseline (V1) and 1st month (4 weeks (V2)) and between baseline and the end of the study (8 weeks (V3))
Depression level evaluated by the Center of Epidemiologic Studies Depression scale (CES-D) score
Time frame: Baseline (V1) and each evaluation (at 1 week, 2 weeks, 3 weeks, 4 weeks (V2), 5 weeks, 6 weeks, 7 weeks and the end of the study : 8 weeks (V3))
Stress, spleep, anxiety, sadness, energy feeling, attention to others and desire to do things evaluated by Visual Analogic Scales (VAS) score
Time frame: Baseline (V1) and each week evaluation (1 week, 2 weeks, 3 weeks, 4 weeks (V2), 5 weeks, 6 weeks, 7 weeks and the end of the study : 8 weeks (V3))
Pleasure feeling evaluated by the Snaith-Hamilton Pleasure Scale (SHAPS) score
Time frame: Baseline (V1) and each evaluation (2 weeks, 4 weeks (V2), 6 weeks and 8 weeks (V3)
Quality of life evaluated by the Multicultural Quality of Life Index (MQLI)
Time frame: Baseline (V1) and 1st month (4 weeks (V2)) and between baseline and the end of the study (8 weeks (V3))
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 7 Sep 2022.
- Individual participant dataSharing planned: No
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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.
Zakaria NAFLI, MD principal investigator
CEN Experimental
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Nutraceutical and Maltodextrin in people with Anhedonia and Depressed Mood, run by Institut Pasteur de Lille at 1 site in France.
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 25 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 7 Sep 2022. 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 France. 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?
Mood disturbance evaluated by the Profile Of Mood States (POMS) total score (time frame: Baseline (V1)). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 7 Sep 2022.