Ignite Creation Date:
2025-12-25 @ 1:07 AM
Ignite Modification Date:
2025-12-25 @ 11:19 PM
Study NCT ID:
NCT01976793
Status:
COMPLETED
Last Update Posted:
2014-11-13
First Post:
2013-10-24
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Retrospective Observational Study DIANA Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003866', 'term': 'Depressive Disorder'}, {'id': 'D003863', 'term': 'Depression'}], 'ancestors': [{'id': 'D019964', 'term': 'Mood Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}, {'id': 'D001526', 'term': 'Behavioral Symptoms'}, {'id': 'D001519', 'term': 'Behavior'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 450}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-11', 'completionDateStruct': {'date': '2013-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-11-12', 'studyFirstSubmitDate': '2013-10-24', 'studyFirstSubmitQcDate': '2013-11-05', 'lastUpdatePostDateStruct': {'date': '2014-11-13', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2013-11-06', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Duration of treatment considered as time between initiation of antidepressant monotherapy and the alteration and/or augmentation of pharmacotherapy', 'timeFrame': 'up to 6 months', 'description': "Primary objective: The primary objective of this NIS is to evaluate the duration of treatment with an initial antidepressant taken as monotherapy in patients in whom treatment was changed because of suboptimal response at physician's discretion."}], 'secondaryOutcomes': [{'measure': 'Pharmacotherapy strategy for the second line treatment', 'timeFrame': 'up to 6 months', 'description': 'Distribution of the various pharmacotherapy strategies following suboptimal response: (switch; augmentation; combination of switch and augmentation and discontinuation of pharmacotherapy) among the patients population.'}, {'measure': 'International Non-Proprietary Name (INN) of pharmacological agents prescribed for augmentation', 'timeFrame': 'Up to 6 months', 'description': 'Rate of the different pharmacological agents prescribed for augmentation; rout of their administration; mean and median duration of courses of treatment'}, {'measure': 'Doses of pharmacological agents used for augmentation', 'timeFrame': 'Up to 6 months', 'description': 'Mean and median doses of pharmacological agents used for augmentation'}, {'measure': "Source of the patient's referral to a psychiatrist", 'timeFrame': 'up to 6 months', 'description': "Distribution of various sources of the patient's referral to a psychiatrist (psychotherapist; neurologist; internist; physician of other speciality; psychologist; came himself; other; and not known"}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Recurrent depressive disorder', 'Depression', 'Depressive episode', 'Atypical antipsychotics'], 'conditions': ['Major Depressive Episode']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'http://filehosting.pharmacm.com/DownloadService.ashx?client=CTR_MED_7111&studyid=1913&filename=NIS-NRU-ATC-2013-1_Clinical_Study_Report_Synopsis.pdf', 'label': 'NIS-NRU-ATC-2013/1 Clinical Study Report Synopsis'}]}, 'descriptionModule': {'briefSummary': "This Non-Interventional Study (NIS) is intended to evaluate the duration of treatment with an initial antidepressant taken as monotherapy in patients in whom treatment was changed because of suboptimal response at physician's discretion. This will address unmet medical needs of patients with a depressive episode related to RDD (ICD-10, Version 2010), who have failed to respond adequately to initial treatment with an antidepressant and contribute to an understanding of the usual approaches that physicians adopt to monitor initial treatment efficacy in RDD (Recurrent Depressive Disorder). The study will also focus on second-line therapy in hard to treat patients, describing the different pharmacotherapeutic strategies."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Inpatients and outpatients diagnosed with an episode of major depression relating to RDD (ICD-10, Version 2010) during the period from January 1, 2012 till September 30, 2013. Initially treated with antidepressant monotherapy, using a flexible dosage regimen if required, for at least 2 weeks', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n1\\. Female or male aged between 18 and 65 years Inpatients and outpatients diagnosed with an episode of major depression relating to RDD (ICD-10, Version 2010) during the period from January 1, 2012 till September 30, 2013 3. Initially treated with antidepressant monotherapy, using a flexible dosage regimen if required, for at least 2 weeks 4. Initial treatment changed because of a suboptimal response at physician's discretion, which is clearly documented in the patient's medical chart.\n\nExclusion Criteria:\n\nPatients currently participating in any other clinical or non-interventional trial, or have completed their participation with the last 30 days.\n\n2\\. Patients with current psychiatric or general medical conditions which require concomitant use of lithium, thyroid hormones, or atypical antipsychotics 3. Patients with unstable general medical condition. 4. Patients who were pregnant or were suspected to be pregnant during the period when a patient had received treatment for MDE (Major Depressive Episode)."}, 'identificationModule': {'nctId': 'NCT01976793', 'acronym': 'DIANA', 'briefTitle': 'Retrospective Observational Study DIANA Study', 'organization': {'class': 'INDUSTRY', 'fullName': 'AstraZeneca'}, 'officialTitle': 'Retrospective Observational Study to Estimate the Duration of Initial Antidepressant Treatment in Patients With Recurrent Depressive Disorder Who Demonstrated a Suboptimal Response to Therapy: DIANA Study', 'orgStudyIdInfo': {'id': 'NIS-NRU-ATC-2013/1'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'patients with major depression', 'description': 'Inpatients and outpatients diagnosed with an episode of major depression relating to RDD (ICD-10, Version 2010) during the period from January 1, 2012 till September 30, 2013. Initially treated with antidepressant monotherapy, using a flexible dosage regimen if required, for at least 2 week'}]}, 'contactsLocationsModule': {'locations': [{'city': 'Ivanovo', 'country': 'Russia', 'facility': 'Research Site', 'geoPoint': {'lat': 56.99988, 'lon': 40.97257}}, {'city': "Kazan'", 'country': 'Russia', 'facility': 'Research Site', 'geoPoint': {'lat': 55.78874, 'lon': 49.12214}}, {'city': 'Moscow', 'country': 'Russia', 'facility': 'Research Site', 'geoPoint': {'lat': 55.75204, 'lon': 37.61781}}, {'city': 'Nizhny Novgorod', 'country': 'Russia', 'facility': 'Research Site', 'geoPoint': {'lat': 56.32867, 'lon': 44.00205}}, {'city': 'Rostov-on-Don', 'country': 'Russia', 'facility': 'Research Site', 'geoPoint': {'lat': 47.21997, 'lon': 39.70769}}, {'city': 'Saint Petersburg', 'country': 'Russia', 'facility': 'Research Site', 'geoPoint': {'lat': 59.93863, 'lon': 30.31413}}, {'city': 'Stavropol', 'country': 'Russia', 'facility': 'Research Site', 'geoPoint': {'lat': 45.03442, 'lon': 41.9642}}, {'city': 'Yaroslavl', 'country': 'Russia', 'facility': 'Research Site', 'geoPoint': {'lat': 57.62987, 'lon': 39.87368}}], 'overallOfficials': [{'name': 'Alla Avedisova, Prof', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Center of Social and Forensic Psychiatry, Moscow'}, {'name': 'Karin Otter, PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'AstraZeneca Russia'}, {'name': 'Anatoly Smulevich, Prof', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Scientific centef of Mental Health, Moscow'}, {'name': 'Galina Mazo, Prof', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'St Petersburg Scientific Psyconeurology institute'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'AstraZeneca', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}