Ignite Creation Date:
2025-12-24 @ 4:02 PM
Ignite Modification Date:
2026-03-06 @ 2:04 PM
Study NCT ID:
NCT02279966
Status:
COMPLETED
Last Update Posted:
2017-02-28
First Post:
2014-10-21
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Efficacy of Vortioxetine on Cognitive Dysfunction in Working Patients With 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': 'D000078784', 'term': 'Vortioxetine'}, {'id': 'D017374', 'term': 'Paroxetine'}], 'ancestors': [{'id': 'D010879', 'term': 'Piperazines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D010880', 'term': 'Piperidines'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 152}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-10', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-02', 'completionDateStruct': {'date': '2016-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-02-27', 'studyFirstSubmitDate': '2014-10-21', 'studyFirstSubmitQcDate': '2014-10-30', 'lastUpdatePostDateStruct': {'date': '2017-02-28', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2014-10-31', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in Digit Symbol Substitution Test (DSST): number of correct symbols', 'timeFrame': 'Baseline to Week 8'}], 'secondaryOutcomes': [{'measure': 'Change in Trail Making Test (TMT) score: TMT-A; speed of processing', 'timeFrame': 'Baseline to Week 8'}, {'measure': 'Change in TMT-B; executive functioning', 'timeFrame': 'Baseline to Week 8'}, {'measure': 'Change in reaction time score: Choice Reaction Time (CRT); attention', 'timeFrame': 'Baseline to Week 8'}, {'measure': 'Change in reaction time score: Simple Reaction Time (SRT); psychomotor speed)', 'timeFrame': 'Baseline to Week 8'}, {'measure': 'Change in Stroop Colour Naming Test (STROOP): incongruent score; executive functioning', 'timeFrame': 'Baseline to Week 8'}, {'measure': 'Change in STROOP: congruent score; speed of processing', 'timeFrame': 'Baseline to Week 8'}, {'measure': 'Change in Perceived Deficits Questionnaire - Depression (PDQ-D) total score', 'timeFrame': 'Baseline to Week 8'}, {'measure': 'Change in Montgomery and Asberg Depression Rating Scale (MADRS) total score', 'timeFrame': 'Baseline to Week 8'}, {'measure': 'Change in Clinical Global Impression - Severity of Illness (CGI-S)', 'timeFrame': 'Baseline to Week 8'}, {'measure': 'Clinical Global Impression - Global Improvement (CGI-I) score', 'timeFrame': 'Week 8'}, {'measure': 'Change in the Functioning Assessment Short Test (FAST) total score', 'timeFrame': 'Baseline to Week 8'}, {'measure': 'Change in University of San Diego Performance-based Skills Assessment - Brief (UPSA-B) total score', 'timeFrame': 'Baseline to Week 8'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Major Depressive Disorder']}, 'referencesModule': {'references': [{'pmid': '30439678', 'type': 'DERIVED', 'citation': 'Christensen MC, Sluth LB, McIntyre RS. Validation of the University of California San Diego Performance-based Skills Assessment (UPSA) in major depressive disorder: Replication and extension of initial findings. J Affect Disord. 2019 Feb 15;245:508-516. doi: 10.1016/j.jad.2018.11.034. Epub 2018 Nov 5.'}], 'seeAlsoLinks': [{'url': 'https://www.clinicaltrialsregister.eu/ctr-search/trial/2014-000230-34/results', 'label': 'EMA EudraCT Results: 2014-000230-34'}]}, 'descriptionModule': {'briefSummary': 'To assess the efficacy of acute treatment with 10 mg/day vortioxetine versus placebo on cognitive performance (focusing on the aspect concerning speed of processing, executive functioning, attention) in working patients with major depressive disorder (MDD).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* The patient has MDD, diagnosed according to Diagnostic and Statistical Manual of Mental Disorders, 4th edition, Text Revision (DSM-IV-TR™) recurrent major depressive disorder (MDD) (classification 296.3x).\n* The patient has a MADRS total score ≥26.\n* The patient has had the current major depressive episode (MDE) for ≥3 months.\n* The patient is aged ≥18 and ≤65 years.\n* The patient is employed full or part-time (defined as minimum 50% full time working hours per week). Part time work should not be due to a medical or mental illness other than MDD.\n* The patient has been in the current job/position for at least 3 months.\n* The patient has no plans to change jobs or retire within treatment period.\n* The patient is not on a sick leave, and at the Screening and Randomisation Visits, there are no plans to send the patient on a sick leave.\n* The patient is not receiving disability benefits.\n\nExclusion criteria:\n\n* The patient has a score ≥70 on the DSST (number of correct symbols) at the Baseline Visit.\n* The patient is, in the opinion of the investigator, not able to complete the neuropsychological tests validly at the Baseline Visit.\n* The patient has physical, cognitive, or language impairment of such severity as to adversely affect the validity of the data derived from the neuropsychological tests.\n* The patient is diagnosed with reading disability (dyslexia).\n* The patient has a history of lack of response to previous adequate treatment with vortioxetine or paroxetine.\n* The patient has any current psychiatric disorder or Axis I disorder (according to DSM-IV-TR™ criteria) other than MDD, as assessed using MINI.\n* The patient has a current or has had a diagnosis of dysthymic disorder within 3 months preceding the onset of current episode (DSM-IV-TR™ criteria).\n* The patient has borderline, schizotypal, schizoid, paranoid, or histrionic, antisocial personality disorders (axis II) as comorbid or primary diagnosis (DSM-IV-TR™ criteria).\n* The patient suffers from personality disorders, mental retardation, pervasive development disorder, attention-deficit/hyperactivity disorder, organic mental disorders, or mental disorders due to a general medical condition (DSM-IV-TR™ criteria).\n* The patient has a current diagnosis or history of manic or hypomanic episode, schizophrenia or any other psychotic disorder, including major depression with psychotic features (DSM-IV-TR™ criteria).\n\nOther protocol-defined inclusion and exclusion criteria may apply.'}, 'identificationModule': {'nctId': 'NCT02279966', 'briefTitle': 'Efficacy of Vortioxetine on Cognitive Dysfunction in Working Patients With Major Depressive Disorder', 'organization': {'class': 'INDUSTRY', 'fullName': 'H. Lundbeck A/S'}, 'officialTitle': 'An Interventional, Randomised, Double-blind, Parallel-group, Placebo-controlled, Active-referenced (Paroxetine), Fixed-dose Study on the Efficacy of Vortioxetine on Cognitive Dysfunction in Working Patients With Major Depressive Disorder', 'orgStudyIdInfo': {'id': '15906A'}, 'secondaryIdInfos': [{'id': '2014-000230-34', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Vortioxetine 10 mg', 'description': 'daily, encapsulated, orally', 'interventionNames': ['Drug: Vortioxetine 10 mg']}, {'type': 'OTHER', 'label': 'Paroxetine 20 mg (active reference)', 'description': 'daily, encapsulated, orally', 'interventionNames': ['Drug: Paroxetine 20 mg']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'capsules, orally', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'Vortioxetine 10 mg', 'type': 'DRUG', 'otherNames': ['Brintellix®', 'Lu AA21004'], 'armGroupLabels': ['Vortioxetine 10 mg']}, {'name': 'Paroxetine 20 mg', 'type': 'DRUG', 'armGroupLabels': ['Paroxetine 20 mg (active reference)']}, {'name': 'Placebo', 'type': 'DRUG', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Tallinn', 'country': 'Estonia', 'facility': 'EE001', 'geoPoint': {'lat': 59.43696, 'lon': 24.75353}}, {'city': 'Tallinn', 'country': 'Estonia', 'facility': 'EE002', 'geoPoint': {'lat': 59.43696, 'lon': 24.75353}}, {'city': 'Võru', 'country': 'Estonia', 'facility': 'EE004', 'geoPoint': {'lat': 57.83389, 'lon': 27.01944}}, {'city': 'Helsinki', 'country': 'Finland', 'facility': 'FI002', 'geoPoint': {'lat': 60.16952, 'lon': 24.93545}}, {'city': 'Helsinki', 'country': 'Finland', 'facility': 'FI003', 'geoPoint': {'lat': 60.16952, 'lon': 24.93545}}, {'city': 'Kuopio', 'country': 'Finland', 'facility': 'FI001', 'geoPoint': {'lat': 62.89238, 'lon': 27.67703}}, {'city': 'Oulu', 'country': 'Finland', 'facility': 'FI008', 'geoPoint': {'lat': 65.01236, 'lon': 25.46816}}, {'city': 'Tampere', 'country': 'Finland', 'facility': 'FI007', 'geoPoint': {'lat': 61.49911, 'lon': 23.78712}}, {'city': 'Berlin', 'country': 'Germany', 'facility': 'DE002', 'geoPoint': {'lat': 52.52437, 'lon': 13.41053}}, {'city': 'Bielefeld', 'country': 'Germany', 'facility': 'DE001', 'geoPoint': {'lat': 52.03333, 'lon': 8.53333}}, {'city': 'Frankfurt', 'country': 'Germany', 'facility': 'DE003', 'geoPoint': {'lat': 49.68333, 'lon': 10.53333}}, {'city': 'Frankfurt', 'country': 'Germany', 'facility': 'DE007', 'geoPoint': {'lat': 49.68333, 'lon': 10.53333}}, {'city': 'Schwerin', 'country': 'Germany', 'facility': 'DE008', 'geoPoint': {'lat': 53.62937, 'lon': 11.41316}}, {'city': 'Kaunas', 'country': 'Lithuania', 'facility': 'LT002', 'geoPoint': {'lat': 54.90156, 'lon': 23.90909}}, {'city': 'Palanga', 'country': 'Lithuania', 'facility': 'LT006', 'geoPoint': {'lat': 55.9175, 'lon': 21.06861}}, {'city': 'Šilutė', 'country': 'Lithuania', 'facility': 'LT003', 'geoPoint': {'lat': 55.34889, 'lon': 21.48306}}, {'city': 'Vilnius', 'country': 'Lithuania', 'facility': 'LT001', 'geoPoint': {'lat': 54.68916, 'lon': 25.2798}}, {'city': 'Vilnius', 'country': 'Lithuania', 'facility': 'LT005', 'geoPoint': {'lat': 54.68916, 'lon': 25.2798}}], 'overallOfficials': [{'name': 'Email contact via H. Lundbeck A/S', 'role': 'STUDY_DIRECTOR', 'affiliation': 'LundbeckClinicalTrials@lundbeck.com'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'H. Lundbeck A/S', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}