Ignite Creation Date:
2025-12-25 @ 4:23 AM
Ignite Modification Date:
2025-12-26 @ 3:25 AM
Study NCT ID:
NCT01924520
Status:
COMPLETED
Last Update Posted:
2017-02-16
First Post:
2013-08-14
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Oral Multiple-dose Study in Patients With Major Depressive Disorder
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003865', 'term': 'Depressive Disorder, Major'}], 'ancestors': [{'id': 'D003866', 'term': 'Depressive Disorder'}, {'id': 'D019964', 'term': 'Mood Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 32}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-02', 'completionDateStruct': {'date': '2011-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-02-14', 'studyFirstSubmitDate': '2013-08-14', 'studyFirstSubmitQcDate': '2013-08-14', 'lastUpdatePostDateStruct': {'date': '2017-02-16', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2013-08-16', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Maximum plasma concentration (Cmax) of unchanged quetiapine', 'timeFrame': 'for 24 hours after dosing'}, {'measure': 'AUC24h (area under the curve for 24hr) of unchanged quetiapine', 'timeFrame': 'for 24 hours after dosing'}], 'secondaryOutcomes': [{'measure': 'trough value of plasma concentration of unchanged quetiapine', 'timeFrame': 'for 24 hours after dosing'}, {'measure': 't1/2 of plasma concentration of unchanged quetiapine', 'timeFrame': 'for 24 hours after dosing'}, {'measure': 'Maximum plasma concentration (Cmax) of quetiapine metabolites', 'timeFrame': 'for 24 hours after dosing'}, {'measure': 'AUC (area under the curve) of quetiapine metabolites', 'timeFrame': 'for 24 hours after dosing'}, {'measure': 'trough value of plasma concentration of quetiapine metabolites', 'timeFrame': 'for 24 hours after dosing'}, {'measure': 'tmax of plasma concentration of quetiapine metabolites', 'timeFrame': 'for 24 hours after dosing'}, {'measure': 't1/2 of plasma concentration of quetiapine metabolites', 'timeFrame': 'for 24 hours after dosing'}, {'measure': 'Safety assessed by the incidence of adverse events, clinical tab tests, vital signs, 12-lead ECGs and physical exam', 'timeFrame': 'Up to Day 14'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Antipsychotic', 'FK949E', 'Quetiapine'], 'conditions': ['Major Depressive Disorder']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'https://www.astellasclinicalstudyresults.com/hcp/study.aspx?ID=179', 'label': 'Link to results on Astellas Clinical Study Results website'}]}, 'descriptionModule': {'briefSummary': 'A study was to evaluate the safety and plasma concentration changes of quetiapine after repeated administration of FK949E (extended-release formulation of quetiapine) in patients with major depressive disorder (MDD).', 'detailedDescription': 'The objective of the study was to evaluate the safety and pharmacokinetics of multiple oral doses of FK949E (extended-release formulation of quetiapine) of three doses in patients with major depressive disorder (MDD).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '64 Years', 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Diagnosis of major depressive disorder by the M.I.N.I. according to the DSM-IV-TR\n* Female patients of childbearing potential with a negative serum pregnancy test result and who were willing and able to use a reliable method of birth control during the study.\n* Patients who could understand and comply with the requirements of the study, as judged by the investigator/sub-investigator.\n\nExclusion Criteria:\n\n* A current or past history of a DSM-IV-TR Axis I disorder other than major depressive disorder within 6 months prior to provision of written informed consent.\n* Diagnosis of a DSM-IV-TR Axis II disorder that was considered to have a major impact on the patient's current psychiatric status.\n* A history of substance or alcohol abuse or dependence excluding caffeine and nicotine.\n* Patients who were unable to abstain from drugs that induce or inhibit the drug-metabolizing enzyme CYP3A4 from 14 days prior to screening assessment and throughout the study period.\n* Patients showing evidence or signs of renal or hepatic failure, serious heart disease, cerebrovascular disease, viral hepatitis B or C, or acquired immunodeficiency syndrome (AIDS) (carrier).\n* Patients being treated for hypertension or patients with clinical finding that in the opinion of the investigator/sub-investigator could be negatively affected by the study or that would affect the study results (e.g., hypertension, unstable angina).\n* Patients with concomitant hypotension or orthostatic hypotension (hypotension is defined as systolic blood pressure of less than 100 mmHg)\n* Conditions that could affect absorption and metabolism of the study medication (e.g., malabsorption syndrome, liver disease)\n* A current diagnosis of malignant tumor unless in remission for at least 5 years (except basal or squamous cell skin carcinoma).\n* A history of transient ischemic attack (TIA).\n* A history of seizure disorder, except for febrile convulsions\n* Application of electroconvulsive therapy within 90 days prior to the start of study drug administration\n* Use of a depot antipsychotic injection and inability to be off the drug for a period of twice the dosing interval prior to screening assessment and throughout the study period\n* A score of ≥ 3 on the HAM-D17 Item (suicide) or a suicide attempt within the past 6 months. Patients judged to be at serious suicidal or homicidal risk in the opinion of the investigator/sub-investigator."}, 'identificationModule': {'nctId': 'NCT01924520', 'briefTitle': 'Oral Multiple-dose Study in Patients With Major Depressive Disorder', 'organization': {'class': 'INDUSTRY', 'fullName': 'Astellas Pharma Inc'}, 'officialTitle': 'Phase I Study of FK949E - Phase I Oral Multiple-dose Study in Patients With Major Depressive Disorder', 'orgStudyIdInfo': {'id': '6949-CL-0009'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Group 1 (FK949E lower dose)', 'description': 'Oral', 'interventionNames': ['Drug: FK949E']}, {'type': 'EXPERIMENTAL', 'label': 'Group 2 (FK949E middle dose)', 'description': 'Oral', 'interventionNames': ['Drug: FK949E']}, {'type': 'EXPERIMENTAL', 'label': 'Group 3 (FK949E higher dose)', 'description': 'Oral', 'interventionNames': ['Drug: FK949E']}], 'interventions': [{'name': 'FK949E', 'type': 'DRUG', 'otherNames': ['extended-release formulation of quetiapine'], 'description': 'Oral', 'armGroupLabels': ['Group 1 (FK949E lower dose)', 'Group 2 (FK949E middle dose)', 'Group 3 (FK949E higher dose)']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Kansai', 'country': 'Japan'}, {'city': 'Kantou', 'country': 'Japan'}], 'overallOfficials': [{'name': 'Medical Director', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Astellas Pharma Inc'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Astellas Pharma Inc', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}