Ignite Creation Date:
2025-12-24 @ 1:12 PM
Ignite Modification Date:
2025-12-24 @ 1:12 PM
Study NCT ID:
NCT00531895
Status:
COMPLETED
Last Update Posted:
2007-09-19
First Post:
2007-09-18
Is Possible Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
An Open Trial of Duloxetine on Comorbid Major Depression and Chronic Headache
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003865', 'term': 'Depressive Disorder, Major'}, {'id': 'D020773', 'term': 'Headache Disorders'}], 'ancestors': [{'id': 'D003866', 'term': 'Depressive Disorder'}, {'id': 'D019964', 'term': 'Mood Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}]}, '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': 'ACTUAL', 'count': 30}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2006-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2007-08', 'completionDateStruct': {'date': '2007-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2007-09-18', 'studyFirstSubmitDate': '2007-09-18', 'studyFirstSubmitQcDate': '2007-09-18', 'lastUpdatePostDateStruct': {'date': '2007-09-19', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2007-09-19', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Montgomery-Äsberg Depression Scale (MADRS)', 'timeFrame': '8 weeks'}, {'measure': 'Visual Analog Scale for pain (VAS)', 'timeFrame': '8 weeks'}], 'secondaryOutcomes': [{'measure': 'WHO Quality of Life Scale (WHOQOL BREF)', 'timeFrame': '8 weeks'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['major depression', 'chronic headache', 'antidepressant', 'duloxetine'], 'conditions': ['Major Depression', 'Chronic Primary Headache']}, 'referencesModule': {'references': [{'pmid': '19193344', 'type': 'DERIVED', 'citation': 'Volpe FM. An 8-week, open-label trial of duloxetine for comorbid major depressive disorder and chronic headache. J Clin Psychiatry. 2008 Sep;69(9):1449-54. doi: 10.4088/jcp.v69n0912.'}]}, 'descriptionModule': {'briefSummary': 'Background: Although major depression and chronic headache are strongly associated, there is insufficient evidence on the use of antidepressants for this specific comorbidity. This trial aimed to investigate the efficiency and tolerability of duloxetine for this indication.\n\nMethods: Thirty outpatients of our clinic, with DSM-IV major depression and concurrent primary chronic headache (chronic migraine, chronic tension-type headache or both), 18-55 years, were recruited from April 2006 to March 2007, if they scored \\>21 on the Montgomery-Äsberg Depression Scale (MADRS) and had no other significant clinical condition. Subjects received duloxetine 60 mg/day for 8 weeks. MADRS scores and a visual analog pain scale (VAS) were the co-primary outcome measures. WHO quality of life scale (WHOQoL BREF) scores and headache days/week were secondary outcome measures.Conclusion: In this preliminary open trial, duloxetine 60 mg/day was effective, fast acting and well tolerated for the treatment of comorbid major depression and chronic headache.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '55 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Major depression (according to DSM-IV criteria)\n* MADRS scores superior to 21\n* Subjects meeting the International Headache Society criteria for chronic primary headache (IHSC-2 codes 1.5.1, 1.6.1, 2.3.1, 2.3.2 and 2.4.3) (ICHS, 2003)\n\nExclusion Criteria:\n\n* Over 50% reduction on MADRS scores during wash-out period\n* Illicit drug or alcohol dependence\n* History of multiple allergies or hypersensitivity to duloxetine\n* History of epilepsy or significant neurological disorder\n* Significant suicide risk\n* Pregnancy or lactation\n* Sexually active female subjects not using an efficient contraceptive method\n* Significant laboratory abnormalities at baseline\n* Significant clinical disease\n* Subjects meeting DSM-IV criteria for somatisation disorder. (300.81) or presenting with delusional pain symptoms.'}, 'identificationModule': {'nctId': 'NCT00531895', 'briefTitle': 'An Open Trial of Duloxetine on Comorbid Major Depression and Chronic Headache', 'organization': {'class': 'OTHER', 'fullName': 'Kraepelin Psiquiatria Clinica'}, 'officialTitle': 'An Open Trial of Duloxetine on Comorbid Major Depression and Chronic Headache', 'orgStudyIdInfo': {'id': 'O021'}}, 'armsInterventionsModule': {'interventions': [{'name': 'duloxetine', 'type': 'DRUG', 'otherNames': ['Cymbalta'], 'description': 'duloxetine 60 mg/d'}]}, 'contactsLocationsModule': {'locations': [{'zip': '30000-000', 'city': 'Belo Horizonte', 'state': 'Minas Gerais', 'country': 'Brazil', 'facility': 'Hospital SOCOR', 'geoPoint': {'lat': -19.92083, 'lon': -43.93778}}], 'overallOfficials': [{'name': 'Fernando M Volpe, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Hospital SOCOR'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Kraepelin Psiquiatria Clinica', 'class': 'OTHER'}, 'collaborators': [{'name': 'Eli Lilly and Company', 'class': 'INDUSTRY'}]}}}