Ignite Creation Date:
2025-12-24 @ 7:48 PM
Ignite Modification Date:
2025-12-29 @ 1:45 AM
Study NCT ID:
NCT00368303
Status:
COMPLETED
Last Update Posted:
2012-06-04
First Post:
2006-08-22
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Local Register Study For Major Depression Of Paroxetine Controlled Release
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': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'count': 362}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2006-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2011-03', 'lastUpdateSubmitDate': '2012-05-31', 'studyFirstSubmitDate': '2006-08-22', 'studyFirstSubmitQcDate': '2006-08-22', 'lastUpdatePostDateStruct': {'date': '2012-06-04', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2006-08-24', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Scores on depression rating scale at treatment week 1,2,3,4,6 and 8.'}], 'secondaryOutcomes': [{'measure': 'Scores on clinical impression severity and improvement items at treatment week 1, 2,3,4,6,8'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Major Depression', 'paroxetine controlled release (CR)', 'paroxetine immediate release (IR)'], 'conditions': ['Depressive Disorder, Major', 'Major Depressive Disorder (MDD)']}, 'descriptionModule': {'briefSummary': 'The study is to investigate the non-inferior efficacy of Paroxetine Controlled Release to Paroxetine Immediate Release, as well as the drug tolerability profile when treated on patients with Major Depression.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients with Major Depressive Disorder,score on depression rating scale reach a specific point(17 item Hamilton Depression Scale\\>18).\n\nExclusion criteria:\n\n* patients use monoamine oxidase inhibitors (MAOIs), benzodiazepines, Chinese herbal medicines, acupuncture, moxibustion or other psychoactive medications other than zolpidem, zopiclone;diagnosed with other Axis I disorder other; not responsive to paroxetine therapy before; pregnant or lactating, have serious medical disorder or condition that would preclude the administration of paroxetine; have a history of seizure disorders (except for febrile seizures in childhood); require treatment with warfarin anticoagulants, phenytoin, cimetidine, sumatriptan, type 1C antiarrhythmics, quinidine or sulfonylurea derivatives; are substance abuse or dependence (alcohol or drugs) within 6 months prior to this trial; have had electroconvulsive therapy within 2 months of entry into the study; pose a current, serious suicidal or homicidal risk; have taken other psychotropic drugs or antidepressants other than MAO inhibitors within 7 days of baseline and MAO inhibitors within 14 days of baseline; have taken any investigational drug, or participated in a clinical trial within the past 3 months; are hypersensitivity to paroxetine; have undergoing formal psychotherapy/psychoanalysis.'}, 'identificationModule': {'nctId': 'NCT00368303', 'briefTitle': 'A Local Register Study For Major Depression Of Paroxetine Controlled Release', 'organization': {'class': 'INDUSTRY', 'fullName': 'GlaxoSmithKline'}, 'officialTitle': 'A Multicentre, Double-blind, Active Controlled Trial to Evaluate the Clinical Effects of Immediate Release Paroxetine and Controlled Release Paroxetine in the Treatment of Major Depression', 'orgStudyIdInfo': {'id': 'PCR103124'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Paroxetine CR', 'type': 'DRUG'}, {'name': 'Paroxetine IR', 'type': 'DRUG', 'otherNames': ['Paroxetine CR']}]}, 'contactsLocationsModule': {'locations': [{'zip': '510370', 'city': 'Guangzhou', 'state': 'Guangdong', 'country': 'China', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 23.11667, 'lon': 113.25}}, {'zip': '071000', 'city': 'Baoding', 'state': 'Hebei', 'country': 'China', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 38.87288, 'lon': 115.46246}}, {'zip': '410011', 'city': 'Changsha', 'state': 'Hunan', 'country': 'China', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 28.19874, 'lon': 112.97087}}, {'zip': '210029', 'city': 'Nanjing', 'state': 'Jiangsu', 'country': 'China', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 32.06167, 'lon': 118.77778}}, {'zip': '710032', 'city': "Xi'an", 'state': 'Shaanxi', 'country': 'China', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 34.25833, 'lon': 108.92861}}, {'zip': '710061', 'city': "Xi'an", 'state': 'Shaanxi', 'country': 'China', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 34.25833, 'lon': 108.92861}}, {'zip': '610041', 'city': 'Chengdu', 'state': 'Sichuan', 'country': 'China', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 30.66667, 'lon': 104.06667}}, {'zip': '650032', 'city': 'Kunming', 'state': 'Yunnan', 'country': 'China', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 25.03889, 'lon': 102.71833}}, {'zip': '100083', 'city': 'Beijing', 'country': 'China', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}, {'zip': '100088', 'city': 'Beijing', 'country': 'China', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}, {'zip': '100096', 'city': 'Beijing', 'country': 'China', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}], 'overallOfficials': [{'name': 'GSK Clinical Trials', 'role': 'STUDY_DIRECTOR', 'affiliation': 'GlaxoSmithKline'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'GlaxoSmithKline', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}