Ignite Creation Date:
2025-12-25 @ 2:44 AM
Ignite Modification Date:
2025-12-30 @ 8:30 PM
Study NCT ID:
NCT01344733
Status:
COMPLETED
Last Update Posted:
2012-03-23
First Post:
2011-04-21
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Non Interventional Study to Investigating the Ratio of Mis-diagnosed Bipolar Symptoms in Patient With Major Depressive Disorder (MDD)
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': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 660}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-03', 'completionDateStruct': {'date': '2012-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2012-03-22', 'studyFirstSubmitDate': '2011-04-21', 'studyFirstSubmitQcDate': '2011-04-28', 'lastUpdatePostDateStruct': {'date': '2012-03-23', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2011-04-29', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'To define the potential bipolarity status in treatment resistant MDD patient population', 'timeFrame': '3 months', 'description': 'assessment of presence of hypomanic symptoms, in order to reduce diagnostic mistakes leading to outcome worsening'}, {'measure': 'Hypomanic condition will be defined if the patient will give positive answer to at least 12 items of HCL32. HCL-32-positive patients is expected to be ranged between 4.3% and 21.3%. The difference between the means in the two groups will be estimated.', 'timeFrame': '3 months'}], 'secondaryOutcomes': [{'measure': 'To collect patient characteristics by evaluation of demographic information', 'timeFrame': '3 months'}, {'measure': 'To collect disease characteristics by evaluation of the number of previous episodes, and the duration of current episode', 'timeFrame': '3 months'}, {'measure': 'To collect information on the ongoing treatment', 'timeFrame': '3 months'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Major Depressive Disorder', 'MDD'], 'conditions': ['Major Depressive Disorder', 'MDD']}, 'descriptionModule': {'briefSummary': 'The study will only detect hypomanic symptoms in treatment resistant MDD patients by mean of HCL-32 administration. Further re-evaluation of MDD diagnosis is not a direct aim of the study. No efficacy and tolerability of pharmacological treatments will be assessed. Patients matching inclusion and exclusion criteria will be enrolled consecutively; each investigator will include the first 10 to 40 patients that will be visited as treatment resistant MDD.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients with treatment resistant major depressive disorder will be evaluated in order to assess the presence of hypomanic symptoms as cause of resistance.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Written informed consent form\n* Male and Female age: 18-65 years\n* Diagnosis of MDD according to DSM-IV TR (296.3 x Major Depressive Disorder, recurrent)\n* Treatment resistance defined as non-response to at least 2 antidepressants given in an ade\n\nExclusion Criteria:\n\n* Patients already participating in clinical trial or any other interventional study\n* Patients unable to understand HCL-32 item meaning'}, 'identificationModule': {'nctId': 'NCT01344733', 'acronym': 'Improve', 'briefTitle': 'A Non Interventional Study to Investigating the Ratio of Mis-diagnosed Bipolar Symptoms in Patient With Major Depressive Disorder (MDD)', 'organization': {'class': 'INDUSTRY', 'fullName': 'AstraZeneca'}, 'officialTitle': 'A Non - Interventional Study to Investigating the Ratio of Mis-diagnosed Bipolar Symptoms in Patient Diagnosed as With Treatment Resistant Major Depressive Disorder (MDD)', 'orgStudyIdInfo': {'id': 'NIS-NIT-DUM-2010/1'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'MDD', 'description': 'Patients with treatment resistant major depressive disorder will be evaluated in order to assess the presence of hypomanic symptoms as cause of resistance.'}]}, 'contactsLocationsModule': {'locations': [{'city': 'Agrigento', 'state': 'AG', 'country': 'Italy', 'facility': 'Research Site', 'geoPoint': {'lat': 37.31065, 'lon': 13.57661}}, {'city': 'Sciacca', 'state': 'AG', 'country': 'Italy', 'facility': 'Research Site', 'geoPoint': {'lat': 37.50693, 'lon': 13.08399}}, {'city': 'Ancona', 'state': 'AN', 'country': 'Italy', 'facility': 'Research Site', 'geoPoint': {'lat': 43.60717, 'lon': 13.5103}}, {'city': 'Corato', 'state': 'BA', 'country': 'Italy', 'facility': 'Research Site', 'geoPoint': {'lat': 41.15171, 'lon': 16.41143}}, {'city': 'Putignano', 'state': 'BA', 'country': 'Italy', 'facility': 'Research Site', 'geoPoint': {'lat': 40.85106, 'lon': 17.1219}}, {'city': 'Triggiano', 'state': 'BA', 'country': 'Italy', 'facility': 'Research Site', 'geoPoint': {'lat': 41.06549, 'lon': 16.92501}}, {'city': 'Fasano', 'state': 'BR', 'country': 'Italy', 'facility': 'Research Site', 'geoPoint': {'lat': 40.83625, 'lon': 17.36007}}, {'city': 'Bolzano', 'state': 'BZ', 'country': 'Italy', 'facility': 'Research Site', 'geoPoint': {'lat': 46.49067, 'lon': 11.33982}}, {'city': 'Cagliari', 'state': 'CA', 'country': 'Italy', 'facility': 'Research Site', 'geoPoint': {'lat': 39.23054, 'lon': 9.11917}}, {'city': 'Ortona', 'state': 'CH', 'country': 'Italy', 'facility': 'Research Site', 'geoPoint': {'lat': 42.35087, 'lon': 14.40342}}, {'city': 'Cantù', 'state': 'CO', 'country': 'Italy', 'facility': 'Research Site', 'geoPoint': {'lat': 45.74096, 'lon': 9.13084}}, {'city': 'Rogliano', 'state': 'CS', 'country': 'Italy', 'facility': 'Research Site', 'geoPoint': {'lat': 39.17841, 'lon': 16.31709}}, {'city': 'Adrano-Bronte', 'state': 'CT', 'country': 'Italy', 'facility': 'Research Site'}, {'city': 'Lamezia Terme', 'state': 'CZ', 'country': 'Italy', 'facility': 'Research Site', 'geoPoint': {'lat': 38.96255, 'lon': 16.30938}}, {'city': 'Foggia', 'state': 'FG', 'country': 'Italy', 'facility': 'Research Site', 'geoPoint': {'lat': 41.45845, 'lon': 15.55188}}, {'city': 'Firenze- ASL Di Firenze', 'state': 'FI', 'country': 'Italy', 'facility': 'Research Site'}, {'city': 'Genova', 'state': 'GE', 'country': 'Italy', 'facility': 'Research Site', 'geoPoint': {'lat': 45.21604, 'lon': 11.87211}}, {'city': 'Latina', 'state': 'LT', 'country': 'Italy', 'facility': 'Research Site', 'geoPoint': {'lat': 41.46614, 'lon': 12.9043}}, {'city': 'Messina', 'state': 'ME', 'country': 'Italy', 'facility': 'Research Site', 'geoPoint': {'lat': 38.19394, 'lon': 15.55256}}, {'city': 'Rho', 'state': 'MI', 'country': 'Italy', 'facility': 'Research Site', 'geoPoint': {'lat': 45.53245, 'lon': 9.0402}}, {'city': 'Corleone', 'state': 'PA', 'country': 'Italy', 'facility': 'Research Site', 'geoPoint': {'lat': 37.81338, 'lon': 13.3017}}, {'city': 'Palermo', 'state': 'PA', 'country': 'Italy', 'facility': 'Research Site', 'geoPoint': {'lat': 38.1166, 'lon': 13.3636}}, {'city': 'Guidonia', 'state': 'RM', 'country': 'Italy', 'facility': 'Research Site', 'geoPoint': {'lat': 41.99232, 'lon': 12.71876}}, {'city': 'Roma', 'state': 'RM', 'country': 'Italy', 'facility': 'Research Site', 'geoPoint': {'lat': 44.99364, 'lon': 11.10642}}, {'city': 'Capaccio', 'state': 'SA', 'country': 'Italy', 'facility': 'Research Site', 'geoPoint': {'lat': 40.42435, 'lon': 15.07981}}, {'city': 'Savona', 'state': 'SA', 'country': 'Italy', 'facility': 'Research Site', 'geoPoint': {'lat': 44.30905, 'lon': 8.47715}}, {'city': 'Montecchio Maggiore', 'state': 'VI', 'country': 'Italy', 'facility': 'Research Site', 'geoPoint': {'lat': 45.50369, 'lon': 11.412}}, {'city': 'Castellammare di Stabia', 'country': 'Italy', 'facility': 'Research Site', 'geoPoint': {'lat': 40.70211, 'lon': 14.48685}}, {'city': 'Novara', 'country': 'Italy', 'facility': 'Research Site', 'geoPoint': {'lat': 45.44694, 'lon': 8.62118}}], 'overallOfficials': [{'name': 'Dr. Mauro Carta', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'A.O.U. Universitaria di Cagliari'}, {'name': 'Dr. Gino Montagnani', 'role': 'STUDY_CHAIR', 'affiliation': 'Astrazeneca Italy'}, {'name': 'Dr. Raffaele Sabia', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Astrazeneca Italy'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'AstraZeneca', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}