Ignite Creation Date:
2025-12-25 @ 4:33 AM
Ignite Modification Date:
2025-12-26 @ 3:35 AM
Study NCT ID:
NCT01189318
Status:
WITHDRAWN
Last Update Posted:
2015-08-07
First Post:
2010-08-17
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Effects of Seroquel XR on Sleep Architecture 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': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 0}}, 'statusModule': {'overallStatus': 'WITHDRAWN', 'startDateStruct': {'date': '2012-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-08', 'completionDateStruct': {'date': '2014-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-08-05', 'studyFirstSubmitDate': '2010-08-17', 'studyFirstSubmitQcDate': '2010-08-25', 'lastUpdatePostDateStruct': {'date': '2015-08-07', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2010-08-26', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'change from baseline Pittsburgh Quality Index total scores at 4 weeks', 'timeFrame': 'baseline and 4 weeks'}, {'measure': 'change from baseline Pittsburgh Quality Index total scores at 2 weeks', 'timeFrame': 'baseline and 2 weeks'}, {'measure': 'change from baseline Pittsburgh Quality Index total scores at 4 days', 'timeFrame': 'baseline and 4 days'}], 'secondaryOutcomes': [{'measure': 'change from baseline in sleep architecture measured using polysomnography at 4 weeks', 'timeFrame': 'baseline and at 4 weeks'}, {'measure': 'number of participants with adverse events', 'timeFrame': '4 weeks'}, {'measure': 'number of participants with adverse events', 'timeFrame': '2 weeks'}, {'measure': 'number of participants with adverse events', 'timeFrame': '4 days'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Major Depressive Disorder']}, 'descriptionModule': {'briefSummary': 'In this study, patients with major depressive disorder (MDD) who have insomnia symptom are treated with Seroquel XR in an open-label manner for a 4-week period with repeated measurements of insomnia symptoms and sleep parameters using polysomnography.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '20 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Patient Inclusion Criteria:\n\n* Men and women aged between 20 and 65\n* Diagnosis of major depressive disorder as assessed by Structured Clinical Interview for DSM-IV (SCID-IV)\n* A score of 1 or greater on any of the sleep items (items 4, 5, 6) from the Hamilton Depression Rating Scale (HDRS)\n* Provision of written informed consent\n\nHealthy Control Subject Inclusion Criteria:\n\n* Healthy Men and Women aged between 20 and 65\n* Provision of written informed consent\n\nExclusion Criteria:\n\n* Presence of any major physical or neurological illness (e.g.，head trauma， epilepsy，seizure，stroke，cerebral tumor，multiple sclerosis，cerebrovascular disease, narrow-angle glaucoma, drug hypersensitivity，etc.)\n* Diagnosis of any Axis I disorder other than major depressive disorder or presence of symptoms requiring hospitalization\n* Drug abuse in past 3 months\n* Women who are pregnant，breastfeeding, or planning pregnancy\n* Contraindications to drugs used in the study (e.g., allergy, intolerance, etc.)\n* Unstable medical illness or severe abnormality in laboratory test at screening assessment\n* Increase in blood glucose, lipid, and calcium levels at screening\n* Low blood pressure at screening assessment\n* Intelligence quotient below 80\n* Use of any of the following cytochrome P450 3A4 inhibitors in the 14 days preceding enrolment including but not limited to: ketoconazole, itraconazole, fluconazole, erythromycin, clarithromycin, troleandomycin, indinavir, nelfinavir, ritonavir, fluvoxamine and saquinavir\n* Use of any of the following cytochrome P450 3A4 inducers in the 14 days preceding enrolment including but not limited to: phenytoin, carbamazepine, barbiturates, rifampin, St. John's Wort, and glucocorticoids\n* Administration of a depot antipsychotic injection within one dosing interval (for the depot) before randomisation\n* Substance or alcohol dependence at enrolment (except dependence in full remission, and except for caffeine or nicotine dependence), as defined by DSM-IV criteria\n* Opiates, amphetamine, barbiturate, cocaine, cannabis, or hallucinogen abuse by DSM-IV criteria within 3 months prior to enrolment\n* Previous enrolment or randomisation of treatment in the present study.\n* Participation in another drug trial within 4 weeks prior enrolment into this study or longer in accordance with local requirements\n* Medical conditions that would affect absorption, distribution, metabolism, or excretion of study treatment\n* A patient with Diabetes Mellitus\n* An absolute neutrophil count (ANC) of \\<= 1.5 x 10\\^9 per liter\n* Insomnia from other causes of medical or neurological diseases\n* Involvement in the planning and conduct of the study"}, 'identificationModule': {'nctId': 'NCT01189318', 'briefTitle': 'Effects of Seroquel XR on Sleep Architecture in Patients With Major Depressive Disorder', 'organization': {'class': 'OTHER', 'fullName': 'Ewha Womans University'}, 'officialTitle': 'Effects of Seroquel XR (Quetiapine Fumarate Extended-Release) on Sleep Architecture in Patients With Major Depressive Disorder', 'orgStudyIdInfo': {'id': 'D1443C00042'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Seroquel XR', 'description': 'Patients with MDD receives Seroquel XR.', 'interventionNames': ['Drug: Quetiapine Fumarate Extended Release']}, {'type': 'NO_INTERVENTION', 'label': 'healthy control'}], 'interventions': [{'name': 'Quetiapine Fumarate Extended Release', 'type': 'DRUG', 'description': 'Day 1 50mg, Day 2 50mg, Day 3 150mg, Day 4\\~28 50\\~150mg (increments and deduction of 50mg are allowed)', 'armGroupLabels': ['Seroquel XR']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Seoul', 'country': 'South Korea', 'facility': 'Ewha Womans University Medical Center', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}], 'overallOfficials': [{'name': 'Inkyoon Lyoo, MD, PhD, MMS', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Ewha Womans University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ewha Womans University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'In Kyoon Lyoo', 'investigatorAffiliation': 'Ewha Womans University'}}}}