Ignite Creation Date:
2025-12-25 @ 2:03 AM
Ignite Modification Date:
2026-03-01 @ 12:04 PM
Study NCT ID:
NCT00533260
Status:
COMPLETED
Last Update Posted:
2010-12-09
First Post:
2007-09-20
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Non-interventional Naturalistic Project to Investigate the Effect of the Use of SMS Text Service on Treatment Adherence in Patients Treated With Seroquel® (Quetiapine)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001714', 'term': 'Bipolar Disorder'}, {'id': 'D012559', 'term': 'Schizophrenia'}], 'ancestors': [{'id': 'D000068105', 'term': 'Bipolar and Related Disorders'}, {'id': 'D019964', 'term': 'Mood Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}, {'id': 'D019967', 'term': 'Schizophrenia Spectrum and Other Psychotic Disorders'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 128}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2007-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2010-12', 'completionDateStruct': {'date': '2008-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2010-12-07', 'studyFirstSubmitDate': '2007-09-20', 'studyFirstSubmitQcDate': '2007-09-20', 'lastUpdatePostDateStruct': {'date': '2010-12-09', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2007-09-21', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2008-04', 'type': 'ACTUAL'}}, 'conditionsModule': {'keywords': ['Patients with a manic episode or patients diagnosed with schizophrenia , patients who are being treated with quetiapine and are on a stable dosing regime'], 'conditions': ['Bipolar Disorder', 'Schizophrenia']}, 'descriptionModule': {'briefSummary': 'The basic hypothesis of this trial is that forgetfulness and failure to establish a routine that facilitates medication adherence are prominent reasons for non-adherence. Daily use of the SMS text messages is designed to enhance patient adherence with medication by promoting daily routine and demonstrate the feasibility of using SMS technology within normal clinical practice in The Netherlands.\n\nPLEASE NOTE: Seroquel SR and Seroquel XR refer to the same formulation. The SR designation was changed to XR after consultation with FDA.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'The patients who were considered for participation were patients who were being treated with quetiapine according to the Core Data Sheet and who were on a stable dosing regime. They could have been patients with schizophrenia or patients experiencing a manic episode associated with a bipolar disorder. Quetiapine was administered to the patients in regular practice.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* The subjects should be considered eligible for this trail according to the physician:\n\n 1. Patients with a diagnose of schizophrenia or bipolar disorder with a recent manic episode\n 2. Patients who are being treated with quetiapine and are on an effective dose according to the Core Data Sheet; for schizophrenia between 300 and 450 mg (maximum 750 mg) and bipolar disorder between 400 and 800 mg.\n 3. Patients who consent to make the coded data available to AstraZeneca; provision of written informed consent\n 4. Considered eligible for this study and able to understand and comply with the requirements of the study according to the physician\n 5. In possession of a private mobile phone and capable of using this mobile phone to send SMS text messages\n\nExclusion Criteria:\n\n* Subjects who, in the opinion of the Physician, pose an imminent risk of suicide or a danger to themselves or others are excluded from the trial.'}, 'identificationModule': {'nctId': 'NCT00533260', 'acronym': 'SEQUEL', 'briefTitle': 'A Non-interventional Naturalistic Project to Investigate the Effect of the Use of SMS Text Service on Treatment Adherence in Patients Treated With Seroquel® (Quetiapine)', 'organization': {'class': 'INDUSTRY', 'fullName': 'AstraZeneca'}, 'officialTitle': 'A Non-interventional Naturalistic Project to Investigate the Effect of the Use of SMS Text Service on Treatment Adherence in Patients Treated With Seroquel®', 'orgStudyIdInfo': {'id': 'NIS-NNL-SER-2007/1'}}, 'contactsLocationsModule': {'locations': [{'city': 'Almelo', 'country': 'Netherlands', 'facility': 'Research Site', 'geoPoint': {'lat': 52.35667, 'lon': 6.6625}}, {'city': 'Alphen Aan de Rigjn', 'country': 'Netherlands', 'facility': 'Research Site'}, {'city': 'Amersfoort', 'country': 'Netherlands', 'facility': 'Research Site', 'geoPoint': {'lat': 52.155, 'lon': 5.3875}}, {'city': 'Amstelveen', 'country': 'Netherlands', 'facility': 'Research Site', 'geoPoint': {'lat': 52.30083, 'lon': 4.86389}}, {'city': 'Arnhem', 'country': 'Netherlands', 'facility': 'Research Site', 'geoPoint': {'lat': 51.98, 'lon': 5.91111}}, {'city': 'Bennebroek', 'country': 'Netherlands', 'facility': 'Research Site', 'geoPoint': {'lat': 52.32083, 'lon': 4.59861}}, {'city': 'Beverwijk', 'country': 'Netherlands', 'facility': 'Research Site', 'geoPoint': {'lat': 52.48333, 'lon': 4.65694}}, {'city': 'Bosch en Duin', 'country': 'Netherlands', 'facility': 'Research Site', 'geoPoint': {'lat': 52.11667, 'lon': 5.24167}}, {'city': 'Brummen', 'country': 'Netherlands', 'facility': 'Research Site', 'geoPoint': {'lat': 52.09, 'lon': 6.15556}}, {'city': 'Brunssum', 'country': 'Netherlands', 'facility': 'Research Site', 'geoPoint': {'lat': 50.94667, 'lon': 5.97083}}, {'city': 'Doetichem', 'country': 'Netherlands', 'facility': 'Research Site'}, {'city': 'Druten', 'country': 'Netherlands', 'facility': 'Research Site', 'geoPoint': {'lat': 51.88833, 'lon': 5.60556}}, {'city': 'Ede', 'country': 'Netherlands', 'facility': 'Research Site', 'geoPoint': {'lat': 52.03333, 'lon': 5.65833}}, {'city': 'Groningen', 'country': 'Netherlands', 'facility': 'Research Site', 'geoPoint': {'lat': 53.21917, 'lon': 6.56667}}, {'city': 'Haarlem', 'country': 'Netherlands', 'facility': 'Research Site', 'geoPoint': {'lat': 52.38084, 'lon': 4.63683}}, {'city': 'Heerde', 'country': 'Netherlands', 'facility': 'Research Site', 'geoPoint': {'lat': 52.38723, 'lon': 6.04016}}, {'city': 'Helmond', 'country': 'Netherlands', 'facility': 'Research Site', 'geoPoint': {'lat': 51.48167, 'lon': 5.66111}}, {'city': 'Hoofddorp', 'country': 'Netherlands', 'facility': 'Research Site', 'geoPoint': {'lat': 52.3025, 'lon': 4.68889}}, {'city': 'IJmuiden', 'country': 'Netherlands', 'facility': 'Research Site', 'geoPoint': {'lat': 52.4603, 'lon': 4.61048}}, {'city': 'Leeuwarden', 'country': 'Netherlands', 'facility': 'Research Site', 'geoPoint': {'lat': 53.20271, 'lon': 5.80973}}, {'city': 'Maastricht', 'country': 'Netherlands', 'facility': 'Research Site', 'geoPoint': {'lat': 50.84833, 'lon': 5.68889}}, {'city': 'Nijbroek', 'country': 'Netherlands', 'facility': 'Research Site', 'geoPoint': {'lat': 52.29167, 'lon': 6.06111}}, {'city': 'Nijmegen', 'country': 'Netherlands', 'facility': 'Research Site', 'geoPoint': {'lat': 51.8425, 'lon': 5.85278}}, {'city': 'Oegstgeest', 'country': 'Netherlands', 'facility': 'Research Site', 'geoPoint': {'lat': 52.18, 'lon': 4.46944}}, {'city': 'Raalte', 'country': 'Netherlands', 'facility': 'Research Site', 'geoPoint': {'lat': 52.38583, 'lon': 6.275}}, {'city': 'Roermond', 'country': 'Netherlands', 'facility': 'Research Site', 'geoPoint': {'lat': 51.19417, 'lon': 5.9875}}, {'city': 'Schagen', 'country': 'Netherlands', 'facility': 'Research Site', 'geoPoint': {'lat': 52.7875, 'lon': 4.79861}}, {'city': 'Steenwijk', 'country': 'Netherlands', 'facility': 'Research Site', 'geoPoint': {'lat': 52.7875, 'lon': 6.12083}}, {'city': 'Tiel', 'country': 'Netherlands', 'facility': 'Research Site', 'geoPoint': {'lat': 51.88667, 'lon': 5.42917}}, {'city': 'Tilburg', 'country': 'Netherlands', 'facility': 'Research Site', 'geoPoint': {'lat': 51.55551, 'lon': 5.0913}}, {'city': 'Venray', 'country': 'Netherlands', 'facility': 'Research Site', 'geoPoint': {'lat': 51.525, 'lon': 5.975}}, {'city': 'Vlaardingen', 'country': 'Netherlands', 'facility': 'Research Site', 'geoPoint': {'lat': 51.9125, 'lon': 4.34167}}, {'city': 'Voorhout', 'country': 'Netherlands', 'facility': 'Research Site', 'geoPoint': {'lat': 52.22167, 'lon': 4.48472}}, {'city': 'Weert', 'country': 'Netherlands', 'facility': 'Research Site', 'geoPoint': {'lat': 51.25167, 'lon': 5.70694}}, {'city': 'Wolfheze', 'country': 'Netherlands', 'facility': 'Research Site', 'geoPoint': {'lat': 52.00333, 'lon': 5.79028}}], 'overallOfficials': [{'name': 'N van Schayk', 'role': 'STUDY_DIRECTOR', 'affiliation': 'AstraZeneca'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'AstraZeneca', 'class': 'INDUSTRY'}, 'responsibleParty': {'oldNameTitle': 'AstraZeneca', 'oldOrganization': 'AstraZeneca'}}}}