Ignite Creation Date:
2025-12-26 @ 5:20 PM
Ignite Modification Date:
2026-02-06 @ 7:04 PM
Study NCT ID:
NCT02036606
Status:
UNKNOWN
Last Update Posted:
2018-08-28
First Post:
2014-01-06
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Racing and Crowded Thoughts in Mood Disorders
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': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'OTHER', 'observationalModel': 'OTHER'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 220}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2014-04', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-08', 'completionDateStruct': {'date': '2020-04', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2018-08-24', 'studyFirstSubmitDate': '2014-01-06', 'studyFirstSubmitQcDate': '2014-01-13', 'lastUpdatePostDateStruct': {'date': '2018-08-28', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2014-01-15', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2019-04', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Validation of the French version of the scale Cognitive Processes Associated with Creativity or CPAC scale (scale that assesses creativity)', 'timeFrame': 'one week'}], 'primaryOutcomes': [{'measure': 'Validation of the scale of Crowded Racing Thoughts Questionary = (RCTQ scale that assesses the two forms of racing thoughts)', 'timeFrame': 'one week', 'description': 'Demonstrated a two-factor structure (crowded and racing) assessment concurrent and discriminant validity.'}], 'secondaryOutcomes': [{'measure': 'Evaluation of executive and temporal mechanisms involved in racing thoughts', 'timeFrame': 'one week'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Bipolar Disorder']}, 'descriptionModule': {'briefSummary': 'Racing thoughts relate to subjective acceleration of thinking which has been essentially associated with manic episodes in bipolar disorder. Qualitatively, the phenomenology of racing thoughts in major depression seems to differ from rumination and pure manic racing thoughts: thoughts of all kinds accumulate in the patient\'s head. Recent qualitative evidence is consistent with the existence of these two kinds of "thought overactivity" related to mood disorders. In order to evaluate this and better understand the psychopathological and cognitive mechanisms that underlie thought overactivity in mood disorders, we have created a 34-item self-questionnaire - the Racing and Crowded Thoughts Questionnaire (RCTQ) and a number of neuropsychological tasks (time perception, cognitive flexibility). Also, given the relationship between mood disorders and creativity, it is likely that thought overactivity is related to increased creativity. We aim at evaluating this relationship through the French version of the Cognitive Processes Associated with Creativity scale (CPAC).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Primary care clinic', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Bipolar disorder or depressive disorder\n* 18 -65 years old\n\nExclusion Criteria:\n\n* neurological conditions or sequelae\n* substance abuse in the last 10 months\n* schizophrenia\n* ADHD\n* Borderline personality disorder\n* Pregnant women- Subjects under legal supervision'}, 'identificationModule': {'nctId': 'NCT02036606', 'briefTitle': 'Racing and Crowded Thoughts in Mood Disorders', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Strasbourg, France'}, 'officialTitle': 'Psychopathological and Cognitive Mechanisms of Racing and Crowded Thoughts in Mood Disorders', 'orgStudyIdInfo': {'id': '5582'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'mood disorders', 'description': 'Questionary and neuropsychological tasks will be administered', 'interventionNames': ['Behavioral: questionary']}, {'label': 'control', 'description': 'Questionary and neuropsychological tasks will be administered', 'interventionNames': ['Behavioral: questionary']}], 'interventions': [{'name': 'questionary', 'type': 'BEHAVIORAL', 'armGroupLabels': ['control', 'mood disorders']}]}, 'contactsLocationsModule': {'locations': [{'zip': '67091', 'city': 'Strasbourg', 'state': 'Alsace', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Gilles Bertschy, PHD MD', 'role': 'CONTACT', 'email': 'gilles.bertschy@chru-strasbourg.fr'}, {'name': 'Gilles Bertschy, PHD MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Service de psychiatrie 2 , Les Hôpitaux Universitaires de Strasbourg', 'geoPoint': {'lat': 48.58392, 'lon': 7.74553}}], 'centralContacts': [{'name': 'Dimitri Sanchez', 'role': 'CONTACT', 'email': 'drci@chru-strasbourg.fr'}], 'overallOfficials': [{'name': 'Gilles Bertschy, PHDMD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Les Hôpitaux Universitaires de Strasbourg'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Strasbourg, France', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}