Ignite Creation Date:
2025-12-24 @ 10:55 PM
Ignite Modification Date:
2026-01-01 @ 11:34 AM
Study NCT ID:
NCT00998569
Status:
COMPLETED
Last Update Posted:
2015-08-31
First Post:
2009-10-14
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Neurocognitive Enhancement in Major Depressive Disorder
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003865', 'term': 'Depressive Disorder, Major'}], 'ancestors': [{'id': 'D003866', 'term': 'Depressive Disorder'}, {'id': 'D019964', 'term': 'Mood Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D014850', 'term': 'Waiting Lists'}], 'ancestors': [{'id': 'D001071', 'term': 'Appointments and Schedules'}, {'id': 'D009934', 'term': 'Organization and Administration'}, {'id': 'D006298', 'term': 'Health Services Administration'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 33}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-08', 'completionDateStruct': {'date': '2012-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-08-27', 'studyFirstSubmitDate': '2009-10-14', 'studyFirstSubmitQcDate': '2009-10-19', 'lastUpdatePostDateStruct': {'date': '2015-08-31', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2009-10-20', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Performance on paper and pencil assessments of neurocognition after treatment, compared to baseline assessment performance', 'timeFrame': '20 weeks'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Major Depressive Disorder']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to examine the effects of neurocognitive enhancement on cognitive abilities and related social and adaptive behaviours in individuals diagnosed with major depressive disorder. Subjects in this study will be randomized to receive Neurocognitive Enhancement Therapy (NET) or to a wait list and then NET . Secondary aims include examining whether the cognitive benefits are potentiated by repeated exposure during in-home practice with complementary exercises. Additionally, the investigators will examine the durability of the effects and their generalization to functional capacity and everyday functional performance after completion of the groups.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Male or Female.\n2. Subjects will be between the ages of 18 and 65, which is the age range with available normative comparison data.\n\nExclusion Criteria:\n\n1. Presence of a medical diagnosis that is associated with known cognitive impairments, such as multiple sclerosis, cerebrovascular accident, dementia, or history of traumatic brain injury.\n2. Subjects with a reading level below grade 6, as assessed with the Wide Range Achievement Test - Reading Recognition Subtest, will be excluded because of the likelihood of not understanding task instructions.\n3. Subjects with uncorrectable vision or hearing impairment that would preclude valid assessments or intervention procedures.'}, 'identificationModule': {'nctId': 'NCT00998569', 'acronym': 'MDDNET', 'briefTitle': 'Neurocognitive Enhancement in Major Depressive Disorder', 'organization': {'class': 'OTHER', 'fullName': "Queen's University"}, 'officialTitle': 'Neurocognitive Enhancement in Major Depressive Disorder', 'orgStudyIdInfo': {'id': 'PSYC-092-09'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Neurocognitive Enhancement', 'description': 'neurocongnitive enhancement', 'interventionNames': ['Behavioral: Neurocognitive Enhancement']}, {'type': 'OTHER', 'label': 'Wait List', 'description': 'no intervention', 'interventionNames': ['Behavioral: Wait List']}], 'interventions': [{'name': 'Neurocognitive Enhancement', 'type': 'BEHAVIORAL', 'description': 'Neurocognitive Enhancement Therapy (NET) uses behavioural treatment strategies that are designed to improve a range of cognitive skills. NET uses strategies such as coaching, repetition, practice, teaching, group discussion, and compensation for deficits by using cognitive strengths.', 'armGroupLabels': ['Neurocognitive Enhancement']}, {'name': 'Wait List', 'type': 'BEHAVIORAL', 'description': 'Participants will be wait listed for 10 weeks, following which time they will receive the intervention previously described.', 'armGroupLabels': ['Wait List']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'K7L 3N6', 'city': 'Kingston', 'state': 'Ontario', 'country': 'Canada', 'facility': "Queen's University", 'geoPoint': {'lat': 44.22976, 'lon': -76.48098}}], 'overallOfficials': [{'name': 'Christopher Bowie, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "Queen's University"}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "Queen's University", 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Ph.D.', 'investigatorFullName': 'Christopher Bowie', 'investigatorAffiliation': "Queen's University"}}}}