Ignite Creation Date:
2025-12-25 @ 5:06 AM
Ignite Modification Date:
2025-12-26 @ 4:09 AM
Study NCT ID:
NCT03508427
Status:
TERMINATED
Last Update Posted:
2023-12-19
First Post:
2017-11-17
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Toi Même: a Mobile System for Measuring Bipolar Illness
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001714', 'term': 'Bipolar Disorder'}], 'ancestors': [{'id': 'D000068105', 'term': 'Bipolar and Related Disorders'}, {'id': 'D019964', 'term': 'Mood Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': 'One-arm study'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 36}}, 'statusModule': {'whyStopped': 'Suspended since april 2020 as the application is temporarily unavailable', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2018-04-12', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-12', 'completionDateStruct': {'date': '2020-12-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-12-18', 'studyFirstSubmitDate': '2017-11-17', 'studyFirstSubmitQcDate': '2018-04-23', 'lastUpdatePostDateStruct': {'date': '2023-12-19', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-04-25', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-12-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Severity of depressive symptoms', 'timeFrame': '3 months study period', 'description': 'Changes in depressive symptoms measured using the Montgomery-Asberg Depression Rating Scale during the 3 months study period.'}, {'measure': 'Severity of manic symptoms', 'timeFrame': '3 months study period', 'description': 'Changes in manic symptoms measured using the Young Mania Rating Scale during the 3 months study period.'}], 'secondaryOutcomes': [{'measure': 'Self-rated depressive symptoms', 'timeFrame': '3 months study period', 'description': 'Differences in self-rated depressive symptom using the Quick Inventory of Depressive Symptomatology (QIDS) during the 3 months study period.'}, {'measure': 'Self-rated manic symptoms', 'timeFrame': '3 months study period', 'description': 'Differences in self-rated manic symptoms using the Altman Mania Self-Rating Scale (ASRM) during the 3 months study period.'}, {'measure': 'Activation levels', 'timeFrame': '3 months study period', 'description': 'Changes in levels of activation measured using the scale Multidimensional Assessment of Thymic States (MAThyS) during the 3 months study period.'}, {'measure': 'Treatment adherence', 'timeFrame': '3 months study period', 'description': 'Differences in treatment adherence using the 10-item Medication Adherence Rating Scale (MARS) during the 3 months study period.'}, {'measure': 'Functional impairment', 'timeFrame': '3 months study period', 'description': 'Differences in functional impairment using the Functioning Assessment Short Test (FAST) during the 3 months study period.'}, {'measure': 'Movement behavior', 'timeFrame': '3 months study period.', 'description': 'Differences in movement behavior using the smartphone motion sensors during the 3 months study period.'}, {'measure': 'Completion rate', 'timeFrame': '3 months study period.', 'description': 'Differences in the completion rate of app self-assessment questionnaires.'}, {'measure': 'Patient acceptance', 'timeFrame': '3 months study period.', 'description': 'Patient acceptance rate measured by a questionnaire'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Bipolar Disorder', 'Smartphone', 'Self-monitoring', 'Objective data'], 'conditions': ['Bipolar Disorder']}, 'referencesModule': {'references': [{'pmid': '32638703', 'type': 'DERIVED', 'citation': 'Dargel AA, Mosconi E, Masson M, Plaze M, Taieb F, Von Platen C, Buivan TP, Pouleriguen G, Sanchez M, Fournier S, Lledo PM, Henry C. Toi Meme, a Mobile Health Platform for Measuring Bipolar Illness Activity: Protocol for a Feasibility Study. JMIR Res Protoc. 2020 Aug 18;9(8):e18818. doi: 10.2196/18818.'}]}, 'descriptionModule': {'briefSummary': 'Bipolar disorder is a severe psychiatric illness with chronic course and it is associated with high risk of relapse and hospitalisation, and many patients do not recover to their previous psychosocial functioning. Major reasons for poor outcomes are delayed intervention for prodromal mood and behavioural symptoms as well as incomplete treatment responses. Current diagnostic approaches used to assess mood symptoms rely on symptom-based categories, which lack sensitivity to detect subtle mood and behavioural changes. Therefore, the ability to better characterizing bipolar patients may allow to detect possible differences in the illness activity.\n\nOn the other hand, there is a growing interest in the potential use of mobile technologies such as mobile apps, smartphone and internet in psychiatric care. Some projects have been testing the potential benefits of mobile apps to assess and treat individuals at-risk or suffering from mood and bipolar disorders, using online signs and symptoms monitoring, yet to the investigators knowledge, none of them have integrated a dimensional approach in a smartphone app to assess mood and behavioural alterations and bipolar illness activity, including subjective and objective data (e.g. physical activity, social activity, etc.).\n\nIn this feasibility study the investigators will evaluate the potential relevance of Toi Même app to self-monitoring mood and behavioural changes in bipolar patients with different mood phases compared to the gold-standard mood rating tools used in clinical practice. All patients will be followed for 3 months, with outcome assessments after 2 weeks, after 1 month, 2 months and after 3 months.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* patients with the current diagnosis of Bipolar disorder type I or type II according to the DSM-5 criteria\n* having an iPhone with iOS version from 9.x with access to wireless Internet connectivity.\n\nExclusion Criteria:\n\n* Current DSM-5 diagnosis of schizophrenia, psychotic disorders, dementia, or mental retardation.\n* Active suicidal ideation or behaviours.'}, 'identificationModule': {'nctId': 'NCT03508427', 'briefTitle': 'Toi Même: a Mobile System for Measuring Bipolar Illness', 'organization': {'class': 'INDUSTRY', 'fullName': 'Institut Pasteur'}, 'officialTitle': 'Toi Même: a Mobile System for Measuring Bipolar Illness Activity - Feasibility Study', 'orgStudyIdInfo': {'id': '2017-004'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Toi Même plus treatment as usual', 'description': 'One-Arm study Intervention: Toi Même self-monitoring smartphone application plus treatment as usual which includes pharmacological and/or psychological treatment.\n\nTool: Toi Même mobile app', 'interventionNames': ['Other: Daily self-monitoring']}], 'interventions': [{'name': 'Daily self-monitoring', 'type': 'OTHER', 'description': 'Toi Même self-monitoring smartphone application plus treatment as usual which includes pharmacological and/or psychological treatment.', 'armGroupLabels': ['Toi Même plus treatment as usual']}]}, 'contactsLocationsModule': {'locations': [{'zip': '92380', 'city': 'Garche', 'country': 'France', 'facility': 'Nightingale Hospitals Paris - Clinique du Château', 'geoPoint': {'lat': 49.39455, 'lon': 6.19775}}, {'zip': '92190', 'city': 'Meudon', 'state': 'Île-de-France Region', 'country': 'France', 'facility': 'Centre Thérapeutique et Preventif de Jour - Troubles Bipolaires (Clinique Bellevue)', 'geoPoint': {'lat': 48.81381, 'lon': 2.235}}, {'zip': '75014', 'city': 'Paris', 'state': 'Île-de-France Region', 'country': 'France', 'facility': 'Centre Hospitalier Sainte Anne', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}], 'overallOfficials': [{'name': 'Chantal Henry, MD PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Institut Pasteur'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Institut Pasteur', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}