Ignite Creation Date:
2026-03-26 @ 3:15 PM
Ignite Modification Date:
2026-03-26 @ 3:15 PM
Study NCT ID:
NCT07427966
Status:
NOT_YET_RECRUITING
Last Update Posted:
2026-02-23
First Post:
2025-12-05
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Psychobiological Markers to Improve Diagnosis and to Predict Affective Episodes in Bipolar Disorder
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003865', 'term': 'Depressive Disorder, Major'}, {'id': 'D019964', 'term': 'Mood Disorders'}, {'id': 'D001714', 'term': 'Bipolar Disorder'}, {'id': 'D009043', 'term': 'Motor Activity'}], 'ancestors': [{'id': 'D003866', 'term': 'Depressive Disorder'}, {'id': 'D001523', 'term': 'Mental Disorders'}, {'id': 'D000068105', 'term': 'Bipolar and Related Disorders'}, {'id': 'D001519', 'term': 'Behavior'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 600}, 'targetDuration': '12 Weeks', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2026-04', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-10', 'completionDateStruct': {'date': '2030-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2026-02-17', 'studyFirstSubmitDate': '2025-12-05', 'studyFirstSubmitQcDate': '2026-02-17', 'lastUpdatePostDateStruct': {'date': '2026-02-23', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-02-23', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2030-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Sleep onset', 'timeFrame': '12 weeks for study 1; 1 year for study 2', 'description': 'Smartwatch measure of sleep onset.'}, {'measure': 'Motor activity', 'timeFrame': '12 weeks for study 1; 1 year for study 2', 'description': 'Smartwatch data on number of steps each half time of the day'}, {'measure': 'Learning rate', 'timeFrame': '12 weeks for study 1; 1 year for study 2', 'description': 'We will administer a reward learning task and use computational modeling to extract a learning rate.'}, {'measure': 'Reward sensitivity', 'timeFrame': '12 weeks for study 1; 1 year for study 2', 'description': 'We will administer a valence go/no go task and use computational model to extract reward sensitivity.'}, {'measure': 'Motivational bias', 'timeFrame': '12 weeks for study 1; 1 year for study 2', 'description': 'We will administer a valence go/no go task and use computational model to extract a motivational bias.'}, {'measure': 'Effort discounting', 'timeFrame': '12 weeks for study 1; 1 year for study 2', 'description': 'We will administer an effort discounting task and use computational modeling to extract an effort discounting parameter.'}, {'measure': 'Foraging exit threshold', 'timeFrame': '12 weeks for study 1; 1 year for study 2', 'description': 'We will administer foraging task and calculate a foraging exit threshold.'}, {'measure': 'Sleep duration', 'timeFrame': '12 weeks for study 1; 1 year for study 2', 'description': 'Smartwatch measure of sleep duration.'}, {'measure': 'Sleep quality', 'timeFrame': '12 weeks for study 1; 1 year for study 2', 'description': 'Smartwatch measure of sleep quality.'}], 'secondaryOutcomes': [{'measure': 'Questionnaire', 'timeFrame': '12 weeks for study 1; 1 year for study 2', 'description': 'Karolinska Sleep Questionnaire (KSQ)'}, {'measure': 'Questionnaire', 'timeFrame': '12 weeks for study 1; 1 year for study 2', 'description': 'Reduced Morningness-Eveningness Questionnaire'}, {'measure': 'Questionnaire', 'timeFrame': '12 weeks for study 1; 1 year for study 2', 'description': 'Center for Epidemiologic Studies Depression Scale Revised (CESD-R)'}, {'measure': 'Questionnaires', 'timeFrame': '12 weeks for study 1; 1 year for study 2', 'description': 'Altman Self-Rating Mania Scale (ASRM)'}, {'measure': 'Questionnaire', 'timeFrame': '12 weeks for study 1; 1 year for study 2', 'description': 'Munich Chronotype Questionnaire (MCTQ)'}, {'measure': 'Questionnaire', 'timeFrame': '12 weeks for study 1; 1 year for study 2', 'description': 'Insomnia Severity'}, {'measure': 'Questionnaire', 'timeFrame': '12 weeks for study 1; 1 year for study 2', 'description': 'Patient Health Questionnaire-9 (PHQ-9)'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Mood disorders', 'Bipolar Disorder', 'Affective disorder assesment', 'Major depressive disorder', 'Cognition', 'Sleep', 'Activity'], 'conditions': ['Major Depressive Disorder', 'Mood Disorders', 'Bipolar Disorder (BD)']}, 'descriptionModule': {'briefSummary': 'This trial has two studies. In study 1, the investigators will explore the relationships between three psychobiological factors (sleep patterns, motor activity, and decision-making ability). The investigators aim to investigate how these factors interact in BD patients. This understanding will facilitate the distinction of BD patients from patients with recurrent depressive disorder (MDD) and healthy controls.\n\nIn study 2, the investigators will continue following patients with bipolar disorder and use the interplay between the three psychobiological factors to develop early markers of full-blown affective episodes.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': '* Healthy control comes from the Stockholm region general population.\n* Patients comes from different psychiatric clinics in the Stockholm region.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\nFor all participants:\n\n* Participants must be capable of giving informed consent.\n* Participants must be able to understand and follow the instructions in the project.\n* Access to a smartphone and ability to use a smartphone and actimeter.\n\nFor patients with bipolar disorder\n\n* Confirmed diagnosis of bipolar disorder (type 1 or type 2) according to ICD-10 after completion of an assessment at a psychiatric clinic in the Stockholm Region.\n* Patients must be euthymic (stable and free from affective episodes) at the time of inclusion.\n* Consent for the research team to access relevant clinical data from patient records.\n\nFor patients with recurrent depression\n\n* Confirmed diagnosis of recurrent depression according to ICD-10 after completion of an assessment at a psychiatric clinic in Region Stockholm.\n* Patients must have been referred for diagnostic assessment with the question of bipolar disorder.\n* Patients must be euthymic (stable and free from affective episodes) at the time of inclusion.\n\nExclusion Criteria:\n\nCommon to all participants:\n\n* Active substance abuse or dependence (alcohol or other substances).\n* Neurological disease or cognitive impairment that may affect study results or compliance with study procedures.\n* Inability to use a smartphone and smartwatch as required by the study.\n* Inability to provide valid informed consent.\n* Inability to understand and follow the study instructions (good knowledge of Swedish is required).\n\nFor adults without psychiatric illness:\n\n* Current or previous psychiatric diagnosis.\n\nFor patients with bipolar disorder and patients with recurrent depression:\n\n* Patients who are in an active affective episode (mania, hypomania or depression) at the time of recruitment.'}, 'identificationModule': {'nctId': 'NCT07427966', 'acronym': 'MoodCatcher', 'briefTitle': 'Psychobiological Markers to Improve Diagnosis and to Predict Affective Episodes in Bipolar Disorder', 'organization': {'class': 'OTHER', 'fullName': 'Karolinska Institutet'}, 'officialTitle': 'Psychobiological Markers to Improve Diagnosis and to Predict Affective Episodes in Bipolar Disorder', 'orgStudyIdInfo': {'id': '2024-03094'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Bipolar Patients', 'description': '150 Individuals with a diagnosis of bipolar disorder will participate in studies 1 and 2'}, {'label': 'New Mood Disorder Patients', 'description': '250 patients from three affective clinics in the Stockholm Region (Northwest Psychiatry, North Stockholm Psychiatry, Southwest Psychiatry) who have been referred for assessment for bipolar disorder. Based on clinical experience, approximately 20% (approximately 50 patients) will ultimately be diagnosed with bipolar disorder, while the remaining 200 patients will retain their diagnosis of recurrent depression and be included as a comparison group in study 1 only. The 50 patients newly diagnosed with bipolar disorder will be included in studies 1 and 2.'}, {'label': 'Healthy control', 'description': '200 Individuals with no major psychiatric disorder will participate in study 1 only.'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Karolinska Institutet', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator, Specialist in Psychiatry', 'investigatorFullName': 'Marc Guitart-Masip', 'investigatorAffiliation': 'Karolinska Institutet'}}}}