Ignite Creation Date:
2025-12-24 @ 2:32 PM
Ignite Modification Date:
2026-02-25 @ 8:15 PM
Study NCT ID:
NCT02287259
Status:
COMPLETED
Last Update Posted:
2019-12-05
First Post:
2014-10-30
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Olanzapine Versus Lithium in the Treatment of Acute Depression in Patients With Bipolar II or Bipolar Not Otherwise Specified(OL Study)
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': 'D000077152', 'term': 'Olanzapine'}, {'id': 'D008094', 'term': 'Lithium'}], 'ancestors': [{'id': 'D001569', 'term': 'Benzodiazepines'}, {'id': 'D001552', 'term': 'Benzazepines'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D008672', 'term': 'Metals, Alkali'}, {'id': 'D004602', 'term': 'Elements'}, {'id': 'D007287', 'term': 'Inorganic Chemicals'}, {'id': 'D019565', 'term': 'Metals, Light'}, {'id': 'D008670', 'term': 'Metals'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 50}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-11', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-12', 'completionDateStruct': {'date': '2019-03-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-12-03', 'studyFirstSubmitDate': '2014-10-30', 'studyFirstSubmitQcDate': '2014-11-07', 'lastUpdatePostDateStruct': {'date': '2019-12-05', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2014-11-10', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2019-03-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in Montgomery- Åsberg Depression Rating(MADRS)', 'timeFrame': 'Baseline and 8 weeks'}], 'secondaryOutcomes': [{'measure': 'Change in Young Mania Rating Scale(YMARS)', 'timeFrame': 'Baseline and 8 weeks'}, {'measure': 'Quick Inventory of Depressive Symptomatology Japanese version(QIDS-J)', 'timeFrame': 'Baseline and 8 weeks'}, {'measure': 'State Trait Anxiety Inventory Form JYZ(STAI)', 'timeFrame': 'Baseline and 8 weeks'}, {'measure': 'Clinical Global Impression for Bipolar Disorder(CGI-BP)', 'timeFrame': 'Baseline and 8 weeks'}]}, 'conditionsModule': {'conditions': ['Bipolar Disorder']}, 'descriptionModule': {'briefSummary': 'Determine the efficacy and tolerability of olanzapine for treatment of acute depression in patients with bipolar II or bipolar disorder NOS compared with lithium.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* major depressive episode in type2 bipolar disorder or bipolar disorder NOS.(MADRS more than 20 point)\n* 18years to 65years\n* subjects who sign the informed consent document\n\nExclusion Criteria:\n\n* don't have Diabetes and abnormal metabolism of sugar\n* not noticed as bipolar disorder\n* have an organic brain disease\n* pregnant or breastfeeding women\n* don't have heart disease\n* have actively suicidal thought(Suicidal ideation score of MADRS is 6)\n* who are judged by the investigator to should be excluded from the study"}, 'identificationModule': {'nctId': 'NCT02287259', 'briefTitle': 'Olanzapine Versus Lithium in the Treatment of Acute Depression in Patients With Bipolar II or Bipolar Not Otherwise Specified(OL Study)', 'organization': {'class': 'OTHER', 'fullName': 'Chiba University'}, 'officialTitle': 'A Randomized, Open Label Trial of Olanzapine Versus Lithium in the Treatment of Acute Depression in Patients With Bipolar II or Bipolar Not Otherwise Specified.', 'orgStudyIdInfo': {'id': 'ChibaU'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Olanzapine', 'description': 'PO start with 2.5mg daily once for 7days, since then flexible dose.', 'interventionNames': ['Drug: olanzapine']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Lithium', 'description': 'PO start with 400mg daily twice for 7days, since then flexible dose.', 'interventionNames': ['Drug: lithium']}], 'interventions': [{'name': 'olanzapine', 'type': 'DRUG', 'armGroupLabels': ['Olanzapine']}, {'name': 'lithium', 'type': 'DRUG', 'armGroupLabels': ['Lithium']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Chiba', 'country': 'Japan', 'facility': 'Chiba University Hospital', 'geoPoint': {'lat': 35.6, 'lon': 140.11667}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Tadashi Hasegawa', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'medical doctor(assistant professor)', 'investigatorFullName': 'Tadashi Hasegawa', 'investigatorAffiliation': 'Chiba University'}}}}