Ignite Creation Date:
2025-12-25 @ 4:54 AM
Ignite Modification Date:
2025-12-26 @ 3:54 AM
Study NCT ID:
NCT01428518
Status:
COMPLETED
Last Update Posted:
2016-04-25
First Post:
2011-09-01
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Special Drug Use Investigation for LAMICTAL Bipolar
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001714', 'term': 'Bipolar Disorder'}], 'ancestors': [{'id': 'D000068105', 'term': 'Bipolar and Related Disorders'}, {'id': 'D019964', 'term': 'Mood Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000077213', 'term': 'Lamotrigine'}], 'ancestors': [{'id': 'D014227', 'term': 'Triazines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 1036}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-04', 'completionDateStruct': {'date': '2016-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-04-21', 'studyFirstSubmitDate': '2011-09-01', 'studyFirstSubmitQcDate': '2011-09-01', 'lastUpdatePostDateStruct': {'date': '2016-04-25', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2011-09-05', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of patients with any adverse drug reaction', 'timeFrame': '1 year'}], 'secondaryOutcomes': [{'measure': 'Occurrence of skin disorder', 'timeFrame': '1 year'}, {'measure': 'Occurrence of suicide-related event and self injurious behaviour', 'timeFrame': '1 year'}, {'measure': 'Occurrence of harming others', 'timeFrame': '1 year'}, {'measure': 'Occurrence of withdrawal symptoms after treatment', 'timeFrame': '1 year'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Bipolar Disorder']}, 'descriptionModule': {'briefSummary': 'This post-marketing surveillance study is designed to collect and assess information on safety and effectiveness of lamotrigine tablets in patients with bipolar disorder in routine clinical practice.\n\n("LAMICTAL" is a trademark of the GlaxoSmithKline group of companies.)'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Japanese patients with bipolar disorder prescribed lamotrigine tablets for the first time', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients with bipolar disorder\n* Patients treated with lamotrigine tablets for the first time\n\nExclusion Criteria:\n\n* Not applicable'}, 'identificationModule': {'nctId': 'NCT01428518', 'briefTitle': 'Special Drug Use Investigation for LAMICTAL Bipolar', 'organization': {'class': 'INDUSTRY', 'fullName': 'GlaxoSmithKline'}, 'officialTitle': 'Special Drug Use Investigation for LAMICTAL Bipolar', 'orgStudyIdInfo': {'id': '115324'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Patients with bipolar disorder', 'description': 'Patients with bipolar disorder prescribed lamotrigine tablets for the first time', 'interventionNames': ['Drug: Lamotrigine tablets']}], 'interventions': [{'name': 'Lamotrigine tablets', 'type': 'DRUG', 'description': 'Administered according to the prescribing information in the locally approved label by the authorities.', 'armGroupLabels': ['Patients with bipolar disorder']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'GSK Clinical Trials', 'role': 'STUDY_DIRECTOR', 'affiliation': 'GlaxoSmithKline'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'GlaxoSmithKline', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}