Ignite Creation Date:
2025-12-24 @ 9:14 PM
Ignite Modification Date:
2025-12-30 @ 11:45 PM
Study NCT ID:
NCT01202604
Status:
COMPLETED
Last Update Posted:
2011-12-20
First Post:
2010-09-14
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Study Evaluating the Efficacy of Administered Maintenance Treatments in Bipolar Disorder I and II.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001714', 'term': 'Bipolar Disorder'}, {'id': 'D000087122', 'term': 'Mania'}], 'ancestors': [{'id': 'D000068105', 'term': 'Bipolar and Related Disorders'}, {'id': 'D019964', 'term': 'Mood Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}, {'id': 'D019954', 'term': 'Neurobehavioral Manifestations'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 294}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2011-12', 'completionDateStruct': {'date': '2011-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2011-12-19', 'studyFirstSubmitDate': '2010-09-14', 'studyFirstSubmitQcDate': '2010-09-14', 'lastUpdatePostDateStruct': {'date': '2011-12-20', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2010-09-16', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The proportion of patients (n, %) who will experience a relapse episode (manic, hypomanic, depressive, mixed)', 'timeFrame': 'During the first 9 months after the acute mood episode or in case of relapse occurrence.'}], 'secondaryOutcomes': [{'measure': 'Description of administered treatments for the management of the acute phase of bipolar disorder [mood stabilizers (n,%), antidepressants (n,%), and antipsychotics (n,%)].', 'timeFrame': '4 months and 9 months after the acute mood episode or in case of relapse occurrence'}, {'measure': 'Description of management of relapse episodes in patients previously receiving treatment during the maintenance phase', 'timeFrame': 'In all visits - during the whole study period (9 months)'}, {'measure': 'YMRS total score, HAM-D total score', 'timeFrame': 'At baseline and final visit (9 months after the acute mood episode)'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Bipolar disorder I and II', 'mood event', 'manic or depressive', 'Greece'], 'conditions': ['Bipolar Disorder']}, 'descriptionModule': {'briefSummary': 'The primary objective of the study is to evaluate the efficacy of administered maintenance treatments in bipolar disorder I and II, defined as the percentage of patients who experience a relapse episode during the first 9 months after a mood event (manic or depressive).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Outpatients diagnosed with bipolar disorder I or II (as per DSM-IV), who have received therapy with at least one atypical antipsychotic for the acute episode and whose treating physician has considered they have entered the maintenance phase.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Subjects who experienced the last acute mood episode during the last 2 months and are in euthymic state (YMRS score ≤12 and HAM-D score ≤12) for at least two weeks\n* Diagnosis of bipolar disorder I or II (as per DSM-IV), with or without rapid cycling\n* Subjects who have been treated with at least one atypical antipsychotic for the management of an acute mood event (manic or depressive) as monotherapy or in combination with other medication\n* Provision of informed consent prior to study participation\n\nExclusion Criteria:\n\n* Subjects fulfilling criteria for diagnosis of any other psychiatric condition (except from bipolar disorder I or II), as per DSM-IV Axis Ι, concomitant organic mental disorder or mental retardation\n* Subjects who have received treatment with a depot\n* Substance abuse or dependence (with the exception of nicotine dependence), as defined by DSM-IV criteria\n* Inability of subjects to comply with the study protocol.'}, 'identificationModule': {'nctId': 'NCT01202604', 'briefTitle': 'A Study Evaluating the Efficacy of Administered Maintenance Treatments in Bipolar Disorder I and II.', 'organization': {'class': 'INDUSTRY', 'fullName': 'AstraZeneca'}, 'officialTitle': 'Prospective, Observational Study for the Maintenance Treatment of Patients With Bipolar Disorder I and II in Greece.', 'orgStudyIdInfo': {'id': 'NIS-NGR-DUM-2010/1'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Outpatients with bipolar disorder I or II (as per DSM-IV)', 'description': 'The percentage of patients who experience a relapse episode during the first 9 months after a mood event (manic or depressive).'}]}, 'contactsLocationsModule': {'locations': [{'city': 'Aigio', 'state': 'Achaias', 'country': 'Greece', 'facility': 'Research Site', 'geoPoint': {'lat': 38.24861, 'lon': 22.08194}}, {'city': 'Ag. Paraskevi', 'state': 'Attikis', 'country': 'Greece', 'facility': 'Research Site'}, {'city': 'Athens', 'state': 'Attikis', 'country': 'Greece', 'facility': 'Research Site', 'geoPoint': {'lat': 37.98376, 'lon': 23.72784}}, {'city': 'Chaïdári', 'state': 'Attikis', 'country': 'Greece', 'facility': 'Research Site', 'geoPoint': {'lat': 38.01135, 'lon': 23.66597}}, {'city': 'Drapetsona', 'state': 'Attikis', 'country': 'Greece', 'facility': 'Research Site', 'geoPoint': {'lat': 37.94988, 'lon': 23.62309}}, {'city': 'Elefsina', 'state': 'Attikis', 'country': 'Greece', 'facility': 'Research Site', 'geoPoint': {'lat': 38.04135, 'lon': 23.54295}}, {'city': 'Glyfada', 'state': 'Attikis', 'country': 'Greece', 'facility': 'Research Site', 'geoPoint': {'lat': 37.86289, 'lon': 23.75802}}, {'city': 'Ilissia', 'state': 'Attikis', 'country': 'Greece', 'facility': 'Research Site'}, {'city': 'Kifissia', 'state': 'Attikis', 'country': 'Greece', 'facility': 'Research Site', 'geoPoint': {'lat': 38.07438, 'lon': 23.81106}}, {'city': 'Koropí', 'state': 'Attikis', 'country': 'Greece', 'facility': 'Research Site', 'geoPoint': {'lat': 37.89886, 'lon': 23.87181}}, {'city': 'Marousi', 'state': 'Attikis', 'country': 'Greece', 'facility': 'Research Site', 'geoPoint': {'lat': 38.05, 'lon': 23.8}}, {'city': 'N. Kosmos', 'state': 'Attikis', 'country': 'Greece', 'facility': 'Research Site'}, {'city': 'Pangrati', 'state': 'Attikis', 'country': 'Greece', 'facility': 'Research Site', 'geoPoint': {'lat': 37.97113, 'lon': 23.74751}}, {'city': 'Petroúpolis', 'state': 'Attikis', 'country': 'Greece', 'facility': 'Research Site', 'geoPoint': {'lat': 38.04187, 'lon': 23.68494}}, {'city': 'Piraeus', 'state': 'Attikis', 'country': 'Greece', 'facility': 'Research Site', 'geoPoint': {'lat': 37.94203, 'lon': 23.64619}}, {'city': 'Thebes', 'state': 'Attikis', 'country': 'Greece', 'facility': 'Research Site', 'geoPoint': {'lat': 38.325, 'lon': 23.31889}}, {'city': 'Vironas', 'state': 'Attikis', 'country': 'Greece', 'facility': 'Research Site'}, {'city': 'Ag. Nikolaos', 'state': 'Crete', 'country': 'Greece', 'facility': 'Research Site'}, {'city': 'Agrinio', 'state': 'Etoloakarnania', 'country': 'Greece', 'facility': 'Research Site', 'geoPoint': {'lat': 38.62139, 'lon': 21.40778}}, {'city': 'Arta', 'state': 'Etoloakarnania', 'country': 'Greece', 'facility': 'Research Site', 'geoPoint': {'lat': 39.16014, 'lon': 20.98561}}, {'city': 'Alexandroupoli', 'state': 'Evros', 'country': 'Greece', 'facility': 'Research Site', 'geoPoint': {'lat': 40.84995, 'lon': 25.87644}}, {'city': 'Lamia', 'state': 'Fhiotidos', 'country': 'Greece', 'facility': 'Research Site', 'geoPoint': {'lat': 38.89947, 'lon': 22.4335}}, {'city': 'Amaliáda', 'state': 'Ilias', 'country': 'Greece', 'facility': 'Research Site', 'geoPoint': {'lat': 37.79842, 'lon': 21.35068}}, {'city': 'Karditsa', 'state': 'Karditsas', 'country': 'Greece', 'facility': 'Research Site', 'geoPoint': {'lat': 39.36485, 'lon': 21.92191}}, {'city': 'Katerini', 'state': 'Katerinis', 'country': 'Greece', 'facility': 'Research Site', 'geoPoint': {'lat': 40.26956, 'lon': 22.50608}}, {'city': 'Kavala', 'state': 'Kavalas', 'country': 'Greece', 'facility': 'Research Site', 'geoPoint': {'lat': 40.93959, 'lon': 24.40687}}, {'city': 'Sparti', 'state': 'Lakonias', 'country': 'Greece', 'facility': 'Research Site', 'geoPoint': {'lat': 37.07446, 'lon': 22.43009}}, {'city': 'Edessa', 'state': 'Pellas', 'country': 'Greece', 'facility': 'Research Site', 'geoPoint': {'lat': 40.8026, 'lon': 22.04751}}, {'city': 'Giannitsá', 'state': 'Pellas', 'country': 'Greece', 'facility': 'Research Site', 'geoPoint': {'lat': 40.79194, 'lon': 22.4075}}, {'city': 'Preveza', 'state': 'Prevezis', 'country': 'Greece', 'facility': 'Research Site', 'geoPoint': {'lat': 38.95617, 'lon': 20.7505}}, {'city': 'Serres', 'state': 'Serres', 'country': 'Greece', 'facility': 'Research Site', 'geoPoint': {'lat': 41.08499, 'lon': 23.54757}}, {'city': 'Thessaloniki', 'state': 'Thessalonikis', 'country': 'Greece', 'facility': 'Research Site', 'geoPoint': {'lat': 40.64072, 'lon': 22.93493}}, {'city': 'Trikala', 'state': 'Trikalon', 'country': 'Greece', 'facility': 'Research Site', 'geoPoint': {'lat': 39.55493, 'lon': 21.76837}}], 'overallOfficials': [{'name': 'Dr. Panagiotis Pontikis', 'role': 'STUDY_DIRECTOR', 'affiliation': 'AstraZeneca S.A. Greece'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'AstraZeneca', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}