Ignite Creation Date:
2025-12-25 @ 2:17 AM
Ignite Modification Date:
2025-12-27 @ 10:59 PM
Study NCT ID:
NCT00788034
Status:
COMPLETED
Last Update Posted:
2015-06-23
First Post:
2008-11-07
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Relapse-prevention Study With Lu AA21004 (Vortioxetine) in Patients With Generalized Anxiety Disorder
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000098647', 'term': 'Generalized Anxiety Disorder'}], 'ancestors': [{'id': 'D001008', 'term': 'Anxiety Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000078784', 'term': 'Vortioxetine'}], 'ancestors': [{'id': 'D010879', 'term': 'Piperazines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 459}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-12', 'completionDateStruct': {'date': '2010-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-06-22', 'studyFirstSubmitDate': '2008-11-07', 'studyFirstSubmitQcDate': '2008-11-07', 'lastUpdatePostDateStruct': {'date': '2015-06-23', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2008-11-10', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Time to relapse', 'timeFrame': 'At least 24 weeks'}], 'secondaryOutcomes': [{'measure': 'Relapse rates, Hamilton Anxiety Rating Scale (HAM-A), Clinical Global Impression Scale (CGI), MOS SF-36, Sheehan Disability Scale (SDS), Adverse events, Clinical laboratory tests, Vital signs, ECG', 'timeFrame': 'At least 24 weeks'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Relapse prevention', 'GAD', 'Maintenance', 'Double-blind', 'Multicentre'], 'conditions': ['Generalized Anxiety Disorder']}, 'referencesModule': {'references': [{'pmid': '22475889', 'type': 'RESULT', 'citation': 'Baldwin DS, Loft H, Florea I. Lu AA21004, a multimodal psychotropic agent, in the prevention of relapse in adult patients with generalized anxiety disorder. Int Clin Psychopharmacol. 2012 Jul;27(4):197-207. doi: 10.1097/YIC.0b013e3283530ad7.'}, {'pmid': '29081307', 'type': 'DERIVED', 'citation': 'Christensen MC, Loft H, Florea I, McIntyre RS. Efficacy of vortioxetine in working patients with generalized anxiety disorder. CNS Spectr. 2019 Apr;24(2):249-257. doi: 10.1017/S1092852917000761. Epub 2017 Oct 30.'}]}, 'descriptionModule': {'briefSummary': 'The study will evaluate the long-term maintenance of efficacy of Lu AA21004 in patients with Generalized Anxiety Disorder (GAD) who responded to acute treatment with Lu AA21004.', 'detailedDescription': 'GAD is a common and disabling mental disorder associated with substantial medical and psychiatric comorbidity and occupational impairment. It is characterized by inappropriate or excessive anxiety and worrying that persists over time for more than six months. Common features include apprehension, with worries about future misfortune; inner tension and difficulty in concentrating; motor tension, with restlessness, tremor and headache; and autonomic anxiety symptoms, with excessive perspiration, dry mouth and epigastric discomfort. GAD is typically a chronic disorder with a high relapse rate and therefore requires effective long-term treatment. Long-term studies are necessary to demonstrate that the short-term effect is maintained.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\nThe patient has GAD as the primary diagnosis according to DSM-IV-TR criteria (classification code 300.02).\n\n* The patient has a HAM-A total score \\>=20 at screening and baseline visits\n* The patient has a HAM-A score \\>=2 on both Item 1 (anxious mood) and Item 2 (tension) at screening and baseline visits\n* The patient has a MADRS total score \\<=16 at screening and baseline visits\n\nExclusion Criteria:\n\n* Any current psychiatric disorder other than GAD as defined in the DSM-IV-TR (assessed with the MINI)\n* Any substance disorder (except nicotine and caffeine) within the previous 6 months as defined in the DSM-IV-TR\n* Women of childbearing potential not using effective contraception\n\nOther protocol-defined inclusion and exclusion criteria may apply.'}, 'identificationModule': {'nctId': 'NCT00788034', 'briefTitle': 'Relapse-prevention Study With Lu AA21004 (Vortioxetine) in Patients With Generalized Anxiety Disorder', 'organization': {'class': 'INDUSTRY', 'fullName': 'H. Lundbeck A/S'}, 'officialTitle': 'A Double-blind, Randomised, Placebo-controlled, Multicentre, Relapse-prevention Study With Lu AA21004 in Patients With Generalized Anxiety Disorder', 'orgStudyIdInfo': {'id': '12473A'}, 'secondaryIdInfos': [{'id': '2008-001673-15', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Lu AA21004', 'interventionNames': ['Drug: Lu AA21004']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'Lu AA21004', 'type': 'DRUG', 'otherNames': ['Vortioxetine'], 'description': '5 or 10 mg/day', 'armGroupLabels': ['Lu AA21004']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Once daily', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '1900', 'city': 'Buenos Aires', 'country': 'Argentina', 'facility': 'AR010', 'geoPoint': {'lat': -34.61315, 'lon': -58.37723}}, {'zip': 'B1900BHE', 'city': 'Buenos Aires', 'country': 'Argentina', 'facility': 'AR012', 'geoPoint': {'lat': -34.61315, 'lon': -58.37723}}, {'zip': 'C1117ABH', 'city': 'Buenos Aires', 'country': 'Argentina', 'facility': 'AR002', 'geoPoint': {'lat': -34.61315, 'lon': -58.37723}}, {'zip': 'C1405BOA', 'city': 'Buenos Aires', 'country': 'Argentina', 'facility': 'AR008', 'geoPoint': {'lat': -34.61315, 'lon': -58.37723}}, {'zip': 'C1425AHQ', 'city': 'Buenos Aires', 'country': 'Argentina', 'facility': 'AR003', 'geoPoint': {'lat': -34.61315, 'lon': -58.37723}}, {'zip': 'C1428AAQ', 'city': 'Buenos Aires', 'country': 'Argentina', 'facility': 'AR013', 'geoPoint': {'lat': -34.61315, 'lon': -58.37723}}, {'zip': '5000', 'city': 'Córdoba', 'country': 'Argentina', 'facility': 'AR004', 'geoPoint': {'lat': -31.40648, 'lon': -64.18853}}, {'zip': '1900', 'city': 'La Plata', 'country': 'Argentina', 'facility': 'AR015', 'geoPoint': {'lat': -34.92126, 'lon': -57.95442}}, {'zip': 'M5500BCR', 'city': 'Mendoza', 'country': 'Argentina', 'facility': 'AR006', 'geoPoint': {'lat': -32.88946, 'lon': -68.84582}}, {'zip': 'M5502BKH', 'city': 'Mendoza', 'country': 'Argentina', 'facility': 'AR009', 'geoPoint': {'lat': -32.88946, 'lon': -68.84582}}, {'zip': 'S2000QJI', 'city': 'Santa Fé', 'country': 'Argentina', 'facility': 'AR001'}, {'city': 'Antofagasta', 'country': 'Chile', 'facility': 'CL004', 'geoPoint': {'lat': -23.65094, 'lon': -70.39752}}, {'city': 'Coquimbo', 'country': 'Chile', 'facility': 'CL001', 'geoPoint': {'lat': -29.95332, 'lon': -71.33947}}, {'city': 'Santiago', 'country': 'Chile', 'facility': 'CL002', 'geoPoint': {'lat': -33.45694, 'lon': -70.64827}}, {'city': 'Santiago', 'country': 'Chile', 'facility': 'CL003', 'geoPoint': {'lat': -33.45694, 'lon': -70.64827}}, {'city': 'Santiago', 'country': 'Chile', 'facility': 'CL005', 'geoPoint': {'lat': -33.45694, 'lon': -70.64827}}, {'city': 'Santiago', 'country': 'Chile', 'facility': 'CL007', 'geoPoint': {'lat': -33.45694, 'lon': -70.64827}}, {'city': 'Santiago', 'country': 'Chile', 'facility': 'CL008', 'geoPoint': {'lat': -33.45694, 'lon': -70.64827}}, {'city': 'Viña del Mar', 'country': 'Chile', 'facility': 'CL006', 'geoPoint': {'lat': -33.02457, 'lon': -71.55183}}, {'city': 'Barranquilla', 'country': 'Colombia', 'facility': 'CO003', 'geoPoint': {'lat': 10.96854, 'lon': -74.78132}}, {'city': 'Bogotá', 'country': 'Colombia', 'facility': 'CO001', 'geoPoint': {'lat': 4.60971, 'lon': -74.08175}}, {'city': 'Bogotá', 'country': 'Colombia', 'facility': 'CO005', 'geoPoint': {'lat': 4.60971, 'lon': -74.08175}}, {'city': 'Envigado', 'country': 'Colombia', 'facility': 'CO006', 'geoPoint': {'lat': 6.17591, 'lon': -75.59174}}, {'city': 'Medellín', 'country': 'Colombia', 'facility': 'CO002', 'geoPoint': {'lat': 6.245, 'lon': -75.57151}}, {'city': 'Medellín', 'country': 'Colombia', 'facility': 'CO007', 'geoPoint': {'lat': 6.245, 'lon': -75.57151}}, {'city': 'Pareira', 'country': 'Colombia', 'facility': 'CO004'}, {'city': 'Escazú', 'country': 'Costa Rica', 'facility': 'CR002', 'geoPoint': {'lat': 9.91887, 'lon': -84.13989}}, {'city': 'Guadalupe', 'country': 'Costa Rica', 'facility': 'CR004', 'geoPoint': {'lat': 9.94805, 'lon': -84.05665}}, {'city': 'San José', 'country': 'Costa Rica', 'facility': 'CR001', 'geoPoint': {'lat': 9.93388, 'lon': -84.08489}}, {'city': 'San Pedro', 'country': 'Costa Rica', 'facility': 'CR003', 'geoPoint': {'lat': 9.92829, 'lon': -84.05074}}, {'zip': '10613', 'city': 'Tallinn', 'country': 'Estonia', 'facility': 'EE001', 'geoPoint': {'lat': 59.43696, 'lon': 24.75353}}, {'zip': '13517', 'city': 'Tallinn', 'country': 'Estonia', 'facility': 'EE004', 'geoPoint': {'lat': 59.43696, 'lon': 24.75353}}, {'zip': '50417', 'city': 'Tartu', 'country': 'Estonia', 'facility': 'EE002', 'geoPoint': {'lat': 58.38062, 'lon': 26.72509}}, {'zip': '2650', 'city': 'Espoo', 'country': 'Finland', 'facility': 'FI006', 'geoPoint': {'lat': 60.2052, 'lon': 24.6522}}, {'zip': '00260', 'city': 'Helsinki', 'country': 'Finland', 'facility': 'FI008', 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'country': 'Russia', 'facility': 'RU002', 'geoPoint': {'lat': 59.93863, 'lon': 30.31413}}, {'zip': '193019', 'city': 'Saint Petersburg', 'country': 'Russia', 'facility': 'RU003', 'geoPoint': {'lat': 59.93863, 'lon': 30.31413}}, {'zip': '634014', 'city': 'Tomsk', 'country': 'Russia', 'facility': 'RU001', 'geoPoint': {'lat': 56.50049, 'lon': 84.98216}}, {'zip': '9033', 'city': 'Bloemfontein', 'country': 'South Africa', 'facility': 'ZA006', 'geoPoint': {'lat': -29.12107, 'lon': 26.214}}, {'zip': '1', 'city': 'Cape Town', 'country': 'South Africa', 'facility': 'ZA004', 'geoPoint': {'lat': -33.92584, 'lon': 18.42322}}, {'zip': '7130', 'city': 'Cape Town', 'country': 'South Africa', 'facility': 'ZA011', 'geoPoint': {'lat': -33.92584, 'lon': 18.42322}}, {'zip': '7130', 'city': 'Cape Town', 'country': 'South Africa', 'facility': 'ZA012', 'geoPoint': {'lat': -33.92584, 'lon': 18.42322}}, {'zip': '7140', 'city': 'Cape Town', 'country': 'South Africa', 'facility': 'ZA003', 'geoPoint': {'lat': 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Lundbeck A/S', 'role': 'STUDY_DIRECTOR', 'affiliation': 'LundbeckClinicalTrials@lundbeck.com'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'H. Lundbeck A/S', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}