Ignite Creation Date:
2025-12-17 @ 2:44 PM
Ignite Modification Date:
2025-12-23 @ 8:39 PM
Study NCT ID:
NCT00071695
Status:
COMPLETED
Last Update Posted:
2007-05-21
First Post:
2003-10-29
Is Possible Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Duloxetine vs. Active Comparator in the Treatment of Patients With Depression
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-22', 'removedCountries': ['Germany', 'Spain', 'United Kingdom']}, 'conditionBrowseModule': {'meshes': [{'id': 'D003863', 'term': 'Depression'}], 'ancestors': [{'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': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'count': 320}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2003-07'}, 'statusVerifiedDate': '2007-05', 'completionDateStruct': {'date': '2004-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2007-05-17', 'studyFirstSubmitDate': '2003-10-29', 'studyFirstSubmitQcDate': '2003-10-29', 'lastUpdatePostDateStruct': {'date': '2007-05-21', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2003-10-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The linear measure of global benefit-risk assessment. Benefit defined as remission at endpoint (HAMD 17 total score less than or equal to 7), a virtually symptom-free state.'}], 'secondaryOutcomes': [{'measure': 'HAMD17 Response Rates defined as greater than or equal to 50% reduction in HAMD17 total score from baseline to endpoint.'}, {'measure': 'HAMD17 Time-to-First Response defined as the visit where a sustained greater than or equal to 30% reduction in the Maier subscale of the HAMD17.'}, {'measure': 'HAMD17 Remission Rates defined as HAMD17 total score of less than or equal to 7 at endpoint.'}, {'measure': 'Hamilton Anxiety Rating Scale measures the presence and severity of anxiety.'}, {'measure': 'Clinical Global Impressions of Severity scale to record severity of illness at the time of assessment.'}, {'measure': "Patient's Global Impressions of Improvement scale measures improvement of the patient's symptoms."}, {'measure': 'HAMD17 Subscales evaluate severity of psychic and somatic manifestations of anxiety as well as agitation and evaluate dysfunction in mood, work, and sexual activity, as well as overall motor retardation and evaluate initial, middle, and late insomnia.'}]}, 'conditionsModule': {'conditions': ['Depression']}, 'referencesModule': {'references': [{'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.'}], 'seeAlsoLinks': [{'url': 'http://www.lillytrials.com', 'label': 'Lilly Clinical Trial Registry'}]}, 'descriptionModule': {'briefSummary': 'How duloxetine compares to a medication currently available for the treatment of patients diagnosed with depression'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Must be at least 18 years of age\n* Must be diagnosed with depression\n* Must sign informed consent\n* Women who can become pregnant must be using birth control\n\nExclusion Criteria:\n\n* Previous diagnosis of bipolar disorder, schizophrenia, or other psychotic disorder\n* History of substance abuse or dependence in the last year\n* Patients who are suicidal\n* Frequent or severe allergic reactions with multiple medications'}, 'identificationModule': {'nctId': 'NCT00071695', 'briefTitle': 'Duloxetine vs. Active Comparator in the Treatment of Patients With Depression', 'organization': {'class': 'INDUSTRY', 'fullName': 'Eli Lilly and Company'}, 'officialTitle': 'Duloxetine Versus Venlafaxine Extended Release in the Treatment of Major Depressive Disorder', 'orgStudyIdInfo': {'id': '6090'}, 'secondaryIdInfos': [{'id': 'F1J-MC-HMBU'}]}, 'armsInterventionsModule': {'interventions': [{'name': 'Duloxetine Hydrochloride', 'type': 'DRUG'}, {'name': 'Venlafaxine Extended Release', 'type': 'DRUG'}]}, 'contactsLocationsModule': {'locations': [{'city': 'La Rochelle', 'country': 'France', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM - 5 PM Easter Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.', 'geoPoint': {'lat': 46.16308, 'lon': -1.15222}}], 'overallOfficials': [{'name': 'Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Eli Lilly and Company'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Eli Lilly and Company', 'class': 'INDUSTRY'}}}}