Ignite Creation Date:
2025-12-24 @ 5:05 PM
Ignite Modification Date:
2025-12-24 @ 5:05 PM
Study NCT ID:
NCT06397950
Status:
TERMINATED
Last Update Posted:
2025-07-31
First Post:
2024-04-30
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Correlates of Fatigue in People With Schizophrenia
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012559', 'term': 'Schizophrenia'}, {'id': 'D009043', 'term': 'Motor Activity'}], 'ancestors': [{'id': 'D019967', 'term': 'Schizophrenia Spectrum and Other Psychotic Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}, {'id': 'D001519', 'term': 'Behavior'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 8}, 'patientRegistry': False}, 'statusModule': {'whyStopped': 'Recruitment difficulties caused by a lack of eligible patients in the investigating center, calling into question the feasibility of the study.', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2024-10-11', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-07', 'completionDateStruct': {'date': '2025-07-29', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-07-29', 'studyFirstSubmitDate': '2024-04-30', 'studyFirstSubmitQcDate': '2024-04-30', 'lastUpdatePostDateStruct': {'date': '2025-07-31', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-05-03', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-07-29', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Strength of predictive model of fatigue in schizophrenia', 'timeFrame': '8 days : 7 days for sleep, sedentary and physical activity levels recording, plus the experimental session (V2) for all other variables', 'description': 'The aim is to determine the relative weight of the measured parameters to explain fatigue variance.\n\n* Fatigue score obtained at the MFI-20 will be selected as the dependent variable.\n* Muscle strength, muscle fatigue, functional abilities, risk of sarcopenia, sleep, cognition, antipsychotic treatment, smoking and coffee consumption, catastrophism, negative symptomatology, and physical activity and sedentary levels will be selected as independent variables.\n* Variables will be entered in a multiple linear regression to establish a predictive model of fatigue.'}], 'secondaryOutcomes': [{'measure': 'Characterization of fatigued people with schizophrenia', 'timeFrame': '8 days : 7 days for sleep, sedentary and physical activity levels recording, plus the experimental session (V2) for all other variables', 'description': 'The aim is to identify which clinical parameters characterize the most fatigued patients (F-group) compared to those who report less fatigue (NF-group)\n\n* Fatigued and less fatigued participants will be separated in two groups using the median score of the MFI-20 questionnaire as a cut point.\n* For each of the variables (muscle strength, muscle fatigue, functional abilities, risk of sarcopenia, sleep, cognition, antipsychotic treatment, smoking and coffee consumption, catastrophism, negative symptomatology, and physical activity and sedentary levels), comparison of means (Student T test or Mann-Whitney U test depending on application conditions) will be used to compare F-group to NF-group.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Trait fatigue', 'Correlates', 'Physical activity', 'Sleep', 'Iatrogenic'], 'conditions': ['Schizophrenia']}, 'descriptionModule': {'briefSummary': 'The goal of this experimental prospective study is to build an explicative model of trait fatigue in adults with schizophrenia engaged in a psychosocial rehabilitation process.\n\nThe main questions it aims to answer are:\n\n* Which factors amongst those evaluated explain the most of fatigue variance in people with schizophrenia?\n* Which clinical factors characterise the most fatigued participants compared to less fatigued participants?\n\nParticipants will wear an accelerometer for seven days to assess their sedentary and physical activity behaviours as well as their sleep.\n\nAfter this, they will undergo an experimental visit, to asses:\n\n* Fatigue\n* Cognitive function\n* Tobacco and caffeine consumption\n* Fatigue catastrophizing\n* Sleep quality\n* Sarcopenia risk\n* Functional capacities\n* Handgrip strength\n* Quadriceps maximal strength and fatigability', 'detailedDescription': 'Schizophrenia is a severe mental illness affecting about 1% of worldwide population. Diagnostic relies on multiple symptoms, divided into three main categories: positive symptoms, negative symptoms and cognitive/dissociative symptoms. Antipsychotic medication is actually the main pharmacologic treatment in schizophrenia but adverse effects can exacerbate other symptoms such as fatigue.\n\nFatigue has a high prevalence in schizophrenia. Unfortunately, fatigue has negative repercussions on daily living activities in this population, and no effective treatment has been identified for now. The lack of effective strategies to manage fatigue in schizophrenia can be due to the lack of knowledge about factors that can explain fatigue. As such, an explicative model of fatigue in schizophrenia has yet to be established.\n\nBecause fatigue is a complex and multifactorial mechanism, investigating its correlates could allow to propose new avenues for its multidisciplinary management, in order to delay its onset or minimize its negative impact. In comparison to healthy subjects, people with schizophrenia show increased physical inactivity and sedentary levels, worsened physical fitness and higher risks of sarcopenia, disturbed sleep, altered cognitive function, increased consumption of psychoactive substances (coffee and tobacco), an increased fatigue catastrophizing. Moreover, negative symptoms could also be linked to fatigue as it has been shown that fatigue could contribute to anhedonia in schizophrenia. Finally, antipsychotic medication can induce sedation, overlapping with fatigue, contributing to an exacerbated experience of the symptom.\n\nTherefore, the goal of this study is to investigate whether physical inactivity, sedentary behaviour, physical fitness, sarcopenia risk, sleep, cognitive capacities, psychoactive substance consumption, fatigue catastrophizing, antipsychotic treatment and negative symptoms could contribute to fatigue in people in schizophrenia.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Participants will be patients with schizophrenia, included in a psychosocial rehabilitation program.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patient with schizophrenia engaged in a psychosocial rehabilitation process.\n* Patient with a stabilised evolution according to usual literature criteria (no modification or increase in antipsychotic treatment during the 4 weeks prior to inclusion).\n* Absence of characterised major depressive episode.\n* Patient affiliated or entitled to a social security scheme.\n* Obtention of free and informed written consent, as well as the free and informed written consent of the guardian in the case of a patient placed under protection measure (guardianship).\n\nExclusion Criteria:\n\n* Physical pain superior to 3 on a visual analog scale.\n* History of severe inflammatory pathology or severe brain trauma.\n* Medical contraindication to moderate-intensity physical activity practice.\n* Patient having electroconvulsive therapy as current treatment.\n* Addiction to toxic products such as alcohol, cannabis or other toxic substances other than tobacco.'}, 'identificationModule': {'nctId': 'NCT06397950', 'acronym': 'FIZO-2', 'briefTitle': 'Correlates of Fatigue in People With Schizophrenia', 'organization': {'class': 'OTHER', 'fullName': 'GCS CIPS'}, 'officialTitle': 'Correlates of Fatigue in People With Schizophrenia', 'orgStudyIdInfo': {'id': 'FIZO-2'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Patients with Schizophrenia', 'description': 'Patients are enrolled in a psychosocial rehabilitation program.', 'interventionNames': ['Other: Assessment of potential fatigue factors']}], 'interventions': [{'name': 'Assessment of potential fatigue factors', 'type': 'OTHER', 'description': '3 visits will be carried out: V0: Inclusion V1: Familiarization visit V2: Experimental visit\n\nV1\n\n* Completion of MFI-20 questionnaire for familiarisation.\n* Information about accelerometry and activity journal use will be delivered to the patient.\n* The participant will be equipped with an accelerometer and asked to complete the activity journal for seven days.\n\nV2\n\n* Completion of questionnaires: MFI-20, GATS tobacco consumption questionnaire, caffeine consumption questionnaire, Fatigue Catastrophizing Scale, PSQI.\n* Assessment of cognitive function: Sustained Attention to Response Task (SART), AX-Continuous Performance Task (AX-CPT) and verbal fluency test (animals and P categories).\n* Assessment of physical evaluation: isometric evaluation of maximal handgrip strength, one-minute sit-to-stand test, isometric evaluation of maximal quadriceps strength, QIF test.\n\nNegative symptoms will be assessed. Calf circumference will be measured for sarcopenia risk.', 'armGroupLabels': ['Patients with Schizophrenia']}]}, 'contactsLocationsModule': {'locations': [{'zip': '83260', 'city': 'La Crau', 'country': 'France', 'facility': 'Clinique INICEA Val Du Fenouillet', 'geoPoint': {'lat': 43.14962, 'lon': 6.07399}}], 'overallOfficials': [{'name': 'Emmanuel MULIN', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'INICEA'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'GCS CIPS', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}