Ignite Creation Date:
2025-12-24 @ 10:19 PM
Ignite Modification Date:
2026-01-03 @ 5:58 AM
Study NCT ID:
NCT00036335
Status:
COMPLETED
Last Update Posted:
2006-07-19
First Post:
2002-05-08
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Subject Information and Consent Form F1J-US-HMCB Duloxetine Once-Daily Dosing Versus Placebo in Patients With Major Depression and Pain
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003863', 'term': 'Depression'}, {'id': 'D010146', 'term': 'Pain'}], 'ancestors': [{'id': 'D001526', 'term': 'Behavioral Symptoms'}, {'id': 'D001519', 'term': 'Behavior'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, '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': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'count': 286}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2002-03'}, 'statusVerifiedDate': '2006-07', 'completionDateStruct': {'date': '2003-01'}, 'lastUpdateSubmitDate': '2006-07-18', 'studyFirstSubmitDate': '2002-05-08', 'studyFirstSubmitQcDate': '2002-05-09', 'lastUpdatePostDateStruct': {'date': '2006-07-19', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2002-05-10', 'type': 'ESTIMATED'}}, 'conditionsModule': {'keywords': ['depression', 'pain', 'blues', 'sadness', 'aches'], 'conditions': ['Depression', 'Pain']}, 'referencesModule': {'references': [{'pmid': '25980552', 'type': 'DERIVED', 'citation': 'Harada E, Kato M, Fujikoshi S, Wohlreich MM, Berggren L, Tokuoka H. Changes in energy during treatment of depression: an analysis of duloxetine in double-blind placebo-controlled trials. Int J Clin Pract. 2015 Oct;69(10):1139-48. doi: 10.1111/ijcp.12658. Epub 2015 May 16.'}, {'pmid': '25080392', 'type': 'DERIVED', 'citation': 'Dodd S, Berk M, Kelin K, Zhang Q, Eriksson E, Deberdt W, Craig Nelson J. Application of the Gradient Boosted method in randomised clinical trials: Participant variables that contribute to depression treatment efficacy of duloxetine, SSRIs or placebo. J Affect Disord. 2014 Oct;168:284-93. doi: 10.1016/j.jad.2014.05.014. Epub 2014 Jun 4.'}]}, 'descriptionModule': {'briefSummary': 'The purposes of this study are to determine whether an investigational drug can help patients suffering from major depression with pain symptoms, and gather data on the safety of the investigational drug including any side effects that might be associated with it.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* You must be suffering from symptoms of depression for at least the past 2 weeks (sadness, loss of interest in daily activities, feelings of hopelessness or guilt, sleeplessness or lack of energy)\n* You must have pain symptoms with no known cause, such as unexplainable, head, chest, or back pain, overall aches and pains, or other unexplainable pains.\n* You need to be available to visit a doctor's office about once a week for 10 weeks.\n\nExclusion Criteria:\n\n* You are a woman and are pregnant or breastfeeding.\n* You have a current or previous diagnosis of bipolar disorder, schizophrenia, or other psychotic disorder.\n* You have had a primary diagnosis of an anxiety disorder within the past 6 months.\n* You have a history of alcohol or drug dependence or abuse within the past 6 months.\n* You have a serious medical illness."}, 'identificationModule': {'nctId': 'NCT00036335', 'briefTitle': 'Subject Information and Consent Form F1J-US-HMCB Duloxetine Once-Daily Dosing Versus Placebo in Patients With Major Depression and Pain', 'organization': {'class': 'INDUSTRY', 'fullName': 'Eli Lilly and Company'}, 'officialTitle': 'Duloxetine Hydrochloride (LY248686) Protocol F1J-US-HMCB Duloxetine Once-Daily Dosing Versus Placebo in Patients With Major Depression and Pain', 'orgStudyIdInfo': {'id': '6353'}, 'secondaryIdInfos': [{'id': 'F1J-US-HMCB'}]}, 'armsInterventionsModule': {'interventions': [{'name': 'Duloxetine Hydrochloride', 'type': 'DRUG'}]}, 'contactsLocationsModule': {'locations': [{'city': 'Peoria', 'state': 'Arizona', 'country': 'United States', 'geoPoint': {'lat': 33.5806, 'lon': -112.23738}}, {'city': 'Burbank', 'state': 'California', 'country': 'United States', 'geoPoint': {'lat': 34.18084, 'lon': -118.30897}}, {'city': 'Fresno', 'state': 'California', 'country': 'United States', 'geoPoint': {'lat': 36.74773, 'lon': -119.77237}}, {'city': 'St. Petersburg', 'state': 'Florida', 'country': 'United States', 'geoPoint': {'lat': 27.77086, 'lon': -82.67927}}, {'city': 'West Palm Beach', 'state': 'Florida', 'country': 'United States', 'geoPoint': {'lat': 26.71534, 'lon': -80.05337}}, {'city': 'Atlanta', 'state': 'Georgia', 'country': 'United States', 'geoPoint': {'lat': 33.749, 'lon': -84.38798}}, {'city': 'Oakbrook Terrace', 'state': 'Illinois', 'country': 'United States', 'geoPoint': {'lat': 41.85003, 'lon': -87.96451}}, {'city': 'Springfield', 'state': 'Illinois', 'country': 'United States', 'geoPoint': {'lat': 39.80172, 'lon': -89.64371}}, {'city': 'Glen Burnie', 'state': 'Maryland', 'country': 'United States', 'geoPoint': {'lat': 39.16261, 'lon': -76.62469}}, {'city': 'Farmington Hills', 'state': 'Michigan', 'country': 'United States', 'geoPoint': {'lat': 42.48531, 'lon': -83.37716}}, {'city': 'Nashua', 'state': 'New Hampshire', 'country': 'United States', 'geoPoint': {'lat': 42.76537, 'lon': -71.46757}}, {'city': 'Clementon', 'state': 'New Jersey', 'country': 'United States', 'geoPoint': {'lat': 39.8115, 'lon': -74.98294}}, {'city': 'Moorestown', 'state': 'New Jersey', 'country': 'United States', 'geoPoint': {'lat': 39.96706, 'lon': -74.94267}}, {'city': 'Albany', 'state': 'New York', 'country': 'United States', 'geoPoint': {'lat': 42.65258, 'lon': -73.75623}}, {'city': 'Olean', 'state': 'New York', 'country': 'United States', 'geoPoint': {'lat': 42.07756, 'lon': -78.42974}}, {'city': 'Cincinnati', 'state': 'Ohio', 'country': 'United States', 'geoPoint': {'lat': 39.12711, 'lon': -84.51439}}, {'city': 'Toledo', 'state': 'Ohio', 'country': 'United States', 'geoPoint': {'lat': 41.66394, 'lon': -83.55521}}, {'city': 'Philadelphia', 'state': 'Pennsylvania', 'country': 'United States', 'geoPoint': {'lat': 39.95238, 'lon': -75.16362}}, {'city': 'Austin', 'state': 'Texas', 'country': 'United States', 'geoPoint': {'lat': 30.26715, 'lon': -97.74306}}, {'city': 'Lake Jackson', 'state': 'Texas', 'country': 'United States', 'geoPoint': {'lat': 29.03386, 'lon': -95.43439}}, {'city': 'San Antonio', 'state': 'Texas', 'country': 'United States', 'geoPoint': {'lat': 29.42412, 'lon': -98.49363}}, {'city': 'Woodstock', 'state': 'Vermont', 'country': 'United States', 'geoPoint': {'lat': 43.62424, 'lon': -72.51843}}, {'city': 'Richmond', 'state': 'Virginia', 'country': 'United States', 'geoPoint': {'lat': 37.55376, 'lon': -77.46026}}, {'city': 'Seattle', 'state': 'Washington', 'country': 'United States', 'geoPoint': {'lat': 47.60621, 'lon': -122.33207}}, {'city': 'Brown Deer', 'state': 'Wisconsin', 'country': 'United States', 'geoPoint': {'lat': 43.16334, 'lon': -87.96453}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Eli Lilly and Company', 'class': 'INDUSTRY'}}}}