Ignite Creation Date:
2025-12-25 @ 12:59 AM
Ignite Modification Date:
2025-12-26 @ 1:18 PM
Study NCT ID:
NCT05306093
Status:
COMPLETED
Last Update Posted:
2022-09-07
First Post:
2022-02-15
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Depressed Mood and Anhedonia in Healthy Adults
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D059445', 'term': 'Anhedonia'}, {'id': 'D003244', 'term': 'Consciousness Disorders'}], 'ancestors': [{'id': 'D019954', 'term': 'Neurobehavioral Manifestations'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D019965', 'term': 'Neurocognitive Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D019587', 'term': 'Dietary Supplements'}, {'id': 'C008315', 'term': 'maltodextrin'}], 'ancestors': [{'id': 'D005502', 'term': 'Food'}, {'id': 'D000066888', 'term': 'Diet, Food, and Nutrition'}, {'id': 'D010829', 'term': 'Physiological Phenomena'}, {'id': 'D019602', 'term': 'Food and Beverages'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 94}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-01-07', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-09', 'completionDateStruct': {'date': '2022-09-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-09-06', 'studyFirstSubmitDate': '2022-02-15', 'studyFirstSubmitQcDate': '2022-03-23', 'lastUpdatePostDateStruct': {'date': '2022-09-07', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-03-31', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-09-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Mood disturbance evaluated by the Profile Of Mood States (POMS) total score', 'timeFrame': 'Baseline (V1)', 'description': '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.'}, {'measure': 'Mood disturbance evaluated by the Profile Of Mood States (POMS) total score', 'timeFrame': 'at 2 weeks', 'description': '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.'}, {'measure': 'Mood disturbance evaluated by the Profile Of Mood States (POMS) total score', 'timeFrame': 'at 4 weeks (V2)', 'description': '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.'}, {'measure': 'Mood disturbance evaluated by the Profile Of Mood States (POMS) total score', 'timeFrame': 'at 6 weeks', 'description': '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.'}, {'measure': 'Mood disturbance evaluated by the Profile Of Mood States (POMS) total score', 'timeFrame': 'at 8 weeks (V3)', 'description': '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.'}], 'secondaryOutcomes': [{'measure': 'Tension, anger, vigour, fatigue and confusion evaluated by the five POMS sub-scores', 'timeFrame': 'Baseline (V1) and 1st month (4 weeks (V2)) and between baseline and the end of the study (8 weeks (V3))', 'description': 'The POMS is a self-reported validated questionnaire assessing six mood subscales: tension-anxiety, depression, anger-hostility, vigor, fatigue, and confusion.'}, {'measure': 'Depression level evaluated by the Center of Epidemiologic Studies Depression scale (CES-D) score', 'timeFrame': '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))', 'description': 'This validated self-reported questionnaire measures levels of depressive symptomatology, with special emphasis on the affective components and depressed mood.'}, {'measure': 'Stress, spleep, anxiety, sadness, energy feeling, attention to others and desire to do things evaluated by Visual Analogic Scales (VAS) score', 'timeFrame': '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))', 'description': '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.\n\nScore 0 to 10.'}, {'measure': 'Pleasure feeling evaluated by the Snaith-Hamilton Pleasure Scale (SHAPS) score', 'timeFrame': 'Baseline (V1) and each evaluation (2 weeks, 4 weeks (V2), 6 weeks and 8 weeks (V3)', 'description': '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.\n\nA total score can be calculated by adding the responses to each question, ranging from 0 (no anhedonia) to 14 (complete anhedonia).'}, {'measure': 'Quality of life evaluated by the Multicultural Quality of Life Index (MQLI)', 'timeFrame': 'Baseline (V1) and 1st month (4 weeks (V2)) and between baseline and the end of the study (8 weeks (V3))', 'description': '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.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['saffron extract'], 'conditions': ['Anhedonia', 'Depressed Mood']}, 'descriptionModule': {'briefSummary': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '20 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Adults aged between 20 and 65 years (limits included);\n* Body Mass Index (BMI) ≥19 and \\< 30 kg/m²;\n* Considered healthy based on their medical history and clinical examination;\n* Subjects self-reporting anhedonia based on SHAPS questionnaire. Score ≥ 3 allows the inclusion;\n* Subjects with depressive mood disturbance based on POMS depression subscale. Score ≥ 4 allows the inclusion;\n* Able and willing to participate to the study by complying with the protocol procedures as evidenced by his dated and signed informed consent form;\n* Affiliated with a social security scheme;\n* Agreeing to be registered on the national file of the volunteers in biomedical research.\n\nExclusion Criteria:\n\n* 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;\n* Having suicidal thoughts: score ≥1 at the item 9 of the PHQ-9;\n* Diagnosis of medical or psychiatric conditions including (but not limited to):\n\n * psychiatric disorder (other than mild-to-moderate depression symptoms, anhedonia or anxiety),\n * neurological disease (Parkinson's, Alzheimer's disease, intracranial haemorrhage, head or brain injury),\n * cancer/malignancy,\n * cardiovascular disease (other than hypertension),\n * Immunological disease,\n * endocrine disease (including diabetes or thyroid diseases, Chronic kidney disease, hematological abnormalities);\n* Smokers (more than 5 cigarettes per day);\n* Uncontrolled hypertension with medication (SBP ≥ 160mmHg or DBP ≥ 100 mmHg) or without medication (SBP ≥ 140mmHg or DBP ≥ 90 mmHg);\n* 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;\n* Undergoing a psychotherapy in the month preceding inclusion or during the study;\n* Consuming more than 3 standard drinks of alcoholic beverage daily;\n* Weight change above 10% body weight within the past 6 months before inclusion;\n* Currently under prescribed diet regimen, whatever the reason;\n* 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;\n* Consuming more than 50g of chocolate/day;\n* For females: Pregnant or planning pregnancy during the study or breastfeeding;\n* Any intolerance or allergy documented or suspected to one of the components of the study products;\n* Taking part in another clinical trial or being in the exclusion period of a previous clinical trial;\n* 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;\n* Under legal protection (guardianship, wardship) or deprived from his rights following administrative or judicial decision;\n* Presenting a psychological or linguistic incapability to sign the informed consent and to answer the study questionnaires\n* 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."}, 'identificationModule': {'nctId': 'NCT05306093', 'acronym': 'MOOD5', 'briefTitle': 'Depressed Mood and Anhedonia in Healthy Adults', 'organization': {'class': 'OTHER', 'fullName': 'Institut Pasteur de Lille'}, 'officialTitle': 'Chronic Effect of a Standardized Saffron Extract on Depressed Mood and Anhedonia in Healthy Adults. A Randomized Controlled Double-blind Clinical Trial.', 'orgStudyIdInfo': {'id': '2021-A02123-38'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Nutraceutical', 'description': 'Daily, 2 dietary supplements will be taken orally with some water, the first one during the breakfast and the second one during the dinner.\n\nDietary supplements in capsule form', 'interventionNames': ['Dietary Supplement: Nutraceutical']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Maltodextrin', 'description': 'Daily, 2 dietary supplements will be taken orally with some water, the first one during the breakfast and the second one during the dinner.\n\nDietary supplements in capsule form', 'interventionNames': ['Dietary Supplement: Maltodextrin']}], 'interventions': [{'name': 'Nutraceutical', 'type': 'DIETARY_SUPPLEMENT', 'description': 'Food supplements are consumed during 8 weeks by healthy volunteers', 'armGroupLabels': ['Nutraceutical']}, {'name': 'Maltodextrin', 'type': 'DIETARY_SUPPLEMENT', 'description': 'Food supplements are consumed during 8 weeks by healthy volunteers', 'armGroupLabels': ['Maltodextrin']}]}, 'contactsLocationsModule': {'locations': [{'zip': '21000', 'city': 'Dijon', 'country': 'France', 'facility': 'CEN Experimental', 'geoPoint': {'lat': 47.31344, 'lon': 5.01391}}], 'overallOfficials': [{'name': 'Zakaria NAFLI, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'CEN Experimental'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Institut Pasteur de Lille', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal investigator', 'investigatorFullName': 'Jean-Michel Lecerf', 'investigatorAffiliation': 'Institut Pasteur de Lille'}}}}