Ignite Creation Date:
2025-12-24 @ 11:49 PM
Ignite Modification Date:
2025-12-25 @ 9:43 PM
Study NCT ID:
NCT03602651
Status:
COMPLETED
Last Update Posted:
2021-08-20
First Post:
2018-07-18
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
MAGZEN® Effect on Recent Anxiety Reaction
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001008', 'term': 'Anxiety Disorders'}], 'ancestors': [{'id': 'D001523', 'term': 'Mental Disorders'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 110}, 'targetDuration': '5 Weeks', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-11-08', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-08', 'completionDateStruct': {'date': '2021-05-14', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-08-19', 'studyFirstSubmitDate': '2018-07-18', 'studyFirstSubmitQcDate': '2018-07-18', 'lastUpdatePostDateStruct': {'date': '2021-08-20', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-07-27', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-05-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'number of "responders patients"', 'timeFrame': '4 weeks', 'description': 'number (%) of "responders patients" with a diminution of the HAM-A score ≥ 50 %'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Anxiety Disorders']}, 'descriptionModule': {'briefSummary': 'Multicentres, observational study, prospective, to evaluate the effect of MAGZEN® in the treatment of recent anxiety reaction.', 'detailedDescription': '107 patients suffering from recent anxiety reaction will be included in the study. They will be treated by MAGZEN® during 4 weeks and we will study the effect of this treatment on the evolution of their anxiety after the cure.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Adult patients suffuring from a recent anxiety reaction not already treated.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* patient suffering from recent anxiety reaction\n* Hamilton-anxiety score ≥ 20 at inclusion\n* recent anxiety disorders (less than 3 months) not treated by pharmacological or psychological treatment\n\nExclusion Criteria:\n\n* major depressive syndrome\n* anxiety disorders more than 3 months\n* anxiety due to death'}, 'identificationModule': {'nctId': 'NCT03602651', 'acronym': 'STRESS2', 'briefTitle': 'MAGZEN® Effect on Recent Anxiety Reaction', 'organization': {'class': 'INDUSTRY', 'fullName': 'Laboratoire Dielen'}, 'officialTitle': 'MAGZEN® Effect on Recent Anxiety Reaction (STRESS2)', 'orgStudyIdInfo': {'id': 'N°ID-RCB : 2018-A01516-49'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'MAGZEN®', 'description': 'All patient will be treated with MAGZEN® and will be evaluated with the Hamilton-anxiety scale (HAM-A)', 'interventionNames': ['Other: Hamilton-anxiety scale (HAM-A)']}], 'interventions': [{'name': 'Hamilton-anxiety scale (HAM-A)', 'type': 'OTHER', 'description': 'Evolution of anxiety disorders is evaluated by the Hamilton-anxiety scale (HAM-A)', 'armGroupLabels': ['MAGZEN®']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Marseille', 'country': 'France', 'facility': 'Private practice', 'geoPoint': {'lat': 43.29695, 'lon': 5.38107}}], 'overallOfficials': [{'name': 'Frédéric MD ROUILLON', 'role': 'STUDY_CHAIR', 'affiliation': 'Hôpital St Anne'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Laboratoire Dielen', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}