Anhedonia Clinical Trial
— MOOD5Official title:
Chronic Effect of a Standardized Saffron Extract on Depressed Mood and Anhedonia in Healthy Adults. A Randomized Controlled Double-blind Clinical Trial.
Verified date | September 2022 |
Source | Institut Pasteur de Lille |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 94 |
Est. completion date | September 1, 2022 |
Est. primary completion date | September 1, 2022 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 20 Years to 65 Years |
Eligibility | Inclusion Criteria: - 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. Exclusion Criteria: - 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, - 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. |
Country | Name | City | State |
---|---|---|---|
France | CEN Experimental | Dijon |
Lead Sponsor | Collaborator |
---|---|
Institut Pasteur de Lille |
France,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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. | Baseline (V1) | |
Primary | 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. | at 2 weeks | |
Primary | 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. | at 4 weeks (V2) | |
Primary | 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. | at 6 weeks | |
Primary | 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. | at 8 weeks (V3) | |
Secondary | 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. | Baseline (V1) and 1st month (4 weeks (V2)) and between baseline and the end of the study (8 weeks (V3)) | |
Secondary | 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. | 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)) | |
Secondary | 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. |
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)) | |
Secondary | 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). |
Baseline (V1) and each evaluation (2 weeks, 4 weeks (V2), 6 weeks and 8 weeks (V3) | |
Secondary | 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. | Baseline (V1) and 1st month (4 weeks (V2)) and between baseline and the end of the study (8 weeks (V3)) |
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