Ignite Creation Date:
2025-12-24 @ 1:05 PM
Ignite Modification Date:
2025-12-28 @ 11:44 AM
Study NCT ID:
NCT02016261
Status:
COMPLETED
Last Update Posted:
2015-07-21
First Post:
2013-12-10
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Study to Evaluate Cognitive Functioning in Remitted Depression During Treatment With Fluvoxamine
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003866', 'term': 'Depressive Disorder'}], 'ancestors': [{'id': 'D019964', 'term': 'Mood Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D016666', 'term': 'Fluvoxamine'}], 'ancestors': [{'id': 'D010091', 'term': 'Oximes'}, {'id': 'D006898', 'term': 'Hydroxylamines'}, {'id': 'D000588', 'term': 'Amines'}, {'id': 'D009930', 'term': 'Organic Chemicals'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 50}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-07', 'completionDateStruct': {'date': '2015-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-07-20', 'studyFirstSubmitDate': '2013-12-10', 'studyFirstSubmitQcDate': '2013-12-13', 'lastUpdatePostDateStruct': {'date': '2015-07-21', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2013-12-19', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change of time difference between Part I and Part II of Stroop Test', 'timeFrame': 'From baseline up to Week 24'}], 'secondaryOutcomes': [{'measure': 'Change of total Frontal Assessment Battery score', 'timeFrame': 'From baseline up to Week 24'}, {'measure': 'Proportion of patients maintained remission status', 'timeFrame': 'Week 24'}, {'measure': "Changes of Addenbrooke's Cognitive Examination general score", 'timeFrame': 'From baseline up to Week 24'}, {'measure': 'Change of The Social Adaptation Self-evaluation Scale total score', 'timeFrame': 'From baseline up to Week 24'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Cognitive function'], 'conditions': ['Recurrent Depressive Disorder']}, 'descriptionModule': {'briefSummary': 'Open label, non-comparative, prospective study to evaluate cognitive functioning in remitted depression outpatients during long-term preventive treatment with Fluvoxamine (Fevarin®)'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n1. Diagnosis of recurrent depressive disorder at least two years prior to enrollment into the study.\n2. At least two severe depressive episodes with or without psychotic symptoms in the past medical history.\n3. Stable patient in remission since at least 4 weeks after depressive episode and not more than 6 months after depressive episode.\n4. Planned prescription of fluvoxamine for preventive therapy in recurrent depressive disorder.\n5. The subject is fluent in Russian language.\n6. According to Stroop test one of following points has to be met - increase of the words reading time on 10% and more or three and more mistakes done.\n7. Sum of Addenbrooke's Cognitive Examination total scores must be 93 or less.\n8. Male or female, between the ages of 18 and 65 years.\n9. If female, postmenopausal or birth control.\n\nExclusion Criteria:\n\n1. Diagnosis of the following concomitant psychiatric disorders: current depressive or maniac episode, bipolar affective disorder, persistent mood affective disorder (cyclothymia, dysthymia, other or unspecified persistent mood disorder), other or unspecified mood affective disorder, substance-related disorders, schizophrenia, or other psychotic disorders.\n2. History of a drug or alcohol disorder.\n3. Current treatment with fluvoxamine.\n4. History of depressive disorder associated with endocrine disorders.\n5. Pregnancy, breast-feeding female patients.\n6. History of any significant neurologic disease.\n7. Treatment with electroconvulsive therapy in the 6 months preceding the study.\n8. Major risk of suicide.\n9. Hypersensitivity to fluvoxamine.\n10. Use of the medications, which are known to interact with fluvoxamine.\n11. Have initiated psychotherapy or other therapies (such as acupuncture or hypnosis).\n12. Have initiated cognitive remediation therapy within 12 weeks prior enrollment or at any time during the study."}, 'identificationModule': {'nctId': 'NCT02016261', 'briefTitle': 'Study to Evaluate Cognitive Functioning in Remitted Depression During Treatment With Fluvoxamine', 'organization': {'class': 'OTHER', 'fullName': 'Moscow Research Institute of Psychiatry'}, 'officialTitle': 'Open Label, Non-comparative Study to Evaluate Cognitive Functioning in Remitted Depression Outpatients During Long-term Preventive Treatment With Fluvoxamine', 'orgStudyIdInfo': {'id': 'A13-996'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Remitted Depression Outpatients', 'description': 'Adults 18-65 years old, males and females with the diagnosis of recurrent depressive disorder and who had at least two severe depressive episodes (with or without psychotic symptoms) of the disorder and who currently in remission', 'interventionNames': ['Drug: Fluvoxamine']}], 'interventions': [{'name': 'Fluvoxamine', 'type': 'DRUG', 'otherNames': ['Fevarin®'], 'description': 'The subjects will be prescribed Fluvoxamine treatment for 24 weeks with dose 50-300 mg', 'armGroupLabels': ['Remitted Depression Outpatients']}]}, 'contactsLocationsModule': {'locations': [{'zip': '107076', 'city': 'Moscow', 'country': 'Russia', 'facility': 'Moscow Research Institution of Psychiatry', 'geoPoint': {'lat': 55.75204, 'lon': 37.61781}}], 'overallOfficials': [{'name': 'Alexey E. Bobrov, Professor', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Moscow Research Institution of Psychiatry'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Moscow Research Institute of Psychiatry', 'class': 'OTHER'}, 'collaborators': [{'name': 'Abbott', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}