Ignite Creation Date:
2025-12-24 @ 10:52 PM
Ignite Modification Date:
2025-12-25 @ 8:21 PM
Study NCT ID:
NCT00889369
Status:
UNKNOWN
Last Update Posted:
2012-02-08
First Post:
2009-04-27
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Duloxetine for Major Depression in Peri-/Postmenopausal Women
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003865', 'term': 'Depressive Disorder, Major'}, {'id': 'D003863', 'term': 'Depression'}], 'ancestors': [{'id': 'D003866', 'term': 'Depressive Disorder'}, {'id': 'D019964', 'term': 'Mood Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}, {'id': 'D001526', 'term': 'Behavioral Symptoms'}, {'id': 'D001519', 'term': 'Behavior'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000068736', 'term': 'Duloxetine Hydrochloride'}], 'ancestors': [{'id': 'D013876', 'term': 'Thiophenes'}, {'id': 'D013457', 'term': 'Sulfur Compounds'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 70}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2009-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2009-06', 'completionDateStruct': {'date': '2012-06', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2012-02-07', 'studyFirstSubmitDate': '2009-04-27', 'studyFirstSubmitQcDate': '2009-04-27', 'lastUpdatePostDateStruct': {'date': '2012-02-08', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2009-04-28', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-02', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The effects of response to treatment with duloxetine on brain structure and activation in subjects (peri- and postmenopausal women with MDD).', 'timeFrame': '10 weeks'}], 'secondaryOutcomes': [{'measure': 'Changes in brain activation in remitters versus non-remitters after treatment with duloxetine (remission of depression defined MADRS total score <10 at study end).', 'timeFrame': '10 weeks'}, {'measure': 'Correlations between changes in brain activation and changes from baseline to study end and menopausal symptoms, depressive symptoms, cognition, quality of life, and clinical global impression (improvement and severity).', 'timeFrame': '10 weeks'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['depression', 'duloxetine', 'menopause', 'imaging', 'FMRI', 'Menopausal staging', 'vasomotor symptoms'], 'conditions': ['Major Depressive Disorder']}, 'referencesModule': {'references': [{'pmid': '20616670', 'type': 'RESULT', 'citation': 'Frey BN, Hall GB, Attard S, Yucel K, Skelin I, Steiner M, Soares CN. Shift in the brain network of emotional regulation in midlife women: is the menopausal transition the turning point? Menopause. 2010 Jul;17(4):840-5. doi: 10.1097/gme.0b013e3181df840f.'}]}, 'descriptionModule': {'briefSummary': 'The main objective of this study is to characterize a range of brain activation symptoms associated with major depression in peri- and post-menopausal women. Also, assessing brain activation before and after the treatment might help to uncover some mechanisms associated with the pathophysiology of depression and menopause.', 'detailedDescription': 'Women approaching menopause and during the post-menopausal years appear to be at greater risk for developing major depressive episodes. Moreover, this period in life has been associated with significant functional impairment due to the presence/severity of vasomotor symptoms (hot flashes, night sweats), cognitive complaints, and poorer quality of life. In light of recent controversies involving the use of hormone therapies, most physicians and patients are seeking nonhormonal strategies to alleviate menopause-related physical and emotional complaints. Duloxetine has been shown to improve major depressive disorder (MDD) and menopause-related symptoms. To date, the effects of this agent on brain structure and functioning in midlife women with MDD have not been explored. The present study aims to investigate the effects of duloxetine on brain structure and functioning when used for the treatment of a major depressive episode in menopausal women using anatomical magnetic resonance imaging (MRI) and functional MRI (fMRI). In addition, the investigators will examine whether the impact of treatment with duloxetine on vasomotor symptoms, cognition, and quality of life modulate the putative changes in brain structure and functioning.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '40 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* peri-/postmenopausal women, aged 40-60 year\n* moderate to severe major depressive episode\n\nExclusion Criteria:\n\n* DSM-IV Axis I diagnosis other than MDD\n* contraindications to magnetic resonance imaging\n* treatment-resistent\n* previous failed treatment with duloxetine\n* history of substance abuse or dependence in past year\n* serious suicidal risk\n* use of other psychotropic medications\n* electroconvulsive therapy or transmagnetic stimulation in past year\n* history of allergic reactions to duloxetine\n* significant laboratory abnormalities at baseline\n* severe hepatic impairment\n* end stage renal disease and undergoing dialysis\n* uncontrolled narrow-angle glaucoma\n* uncontrolled or untreated hyper-/hypothyroidism, or abnormal thyroid stimulating hormone concentration'}, 'identificationModule': {'nctId': 'NCT00889369', 'briefTitle': 'Duloxetine for Major Depression in Peri-/Postmenopausal Women', 'organization': {'class': 'OTHER', 'fullName': 'McMaster University'}, 'officialTitle': 'Duloxetine for the Treatment of Major Depression in Midlife Women: Effects on Brain Structure and Functioning, Mood, and Quality of Life', 'orgStudyIdInfo': {'id': 'WHCC2008-2'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'A', 'description': 'Use of duloxetine, flexible dose (60-120mg/day) for 8 weeks, following a 2-week placebo lead-in phase', 'interventionNames': ['Drug: Duloxetine']}], 'interventions': [{'name': 'Duloxetine', 'type': 'DRUG', 'otherNames': ['Cymbalta (duloxetine)'], 'description': 'Duloxetine, flexible dose, 60-120mg/per day for 8 weeks, following a 2-week placebo lead-in phase to determine study eligibility', 'armGroupLabels': ['A']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'L8P 3B6', 'city': 'Hamilton', 'state': 'Ontario', 'status': 'RECRUITING', 'country': 'Canada', 'contacts': [{'name': 'Stefanie M Attard', 'role': 'CONTACT', 'email': 'sattard@stjoes.ca', 'phone': '905-522-1155', 'phoneExt': '32048'}, {'name': 'Claudio N Soares, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Benicio N Frey, MD, PhD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Geoffrey Hall, PhD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Meir Steiner, MD, PhD', 'role': 'SUB_INVESTIGATOR'}], 'facility': "Women's Health Concerns Clinic", 'geoPoint': {'lat': 43.25011, 'lon': -79.84963}}], 'centralContacts': [{'name': 'Stefanie M Attard', 'role': 'CONTACT', 'email': 'sattard@stjoes.ca', 'phone': '905-522-1155', 'phoneExt': '32048'}, {'name': 'Benicio N Frey, MD, PhD', 'role': 'CONTACT', 'email': 'freybn@mcmaster.ca', 'phone': '905-522-1155', 'phoneExt': '35123'}], 'overallOfficials': [{'name': 'Claudio N Soares, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "St. Joseph's Healthcare; McMaster University"}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hamilton Health Sciences Corporation', 'class': 'OTHER'}, 'collaborators': [{'name': 'Eli Lilly and Company', 'class': 'INDUSTRY'}, {'name': "St. Joseph's Healthcare Hamilton", 'class': 'OTHER'}, {'name': 'McMaster University', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}