Ignite Creation Date:
2025-12-24 @ 8:03 PM
Ignite Modification Date:
2025-12-29 @ 6:54 AM
Study NCT ID:
NCT00955604
Status:
COMPLETED
Last Update Posted:
2017-02-06
First Post:
2009-08-06
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Azilect + Antidepressant Chart Review
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['United States']}, 'conditionBrowseModule': {'meshes': [{'id': 'D020230', 'term': 'Serotonin Syndrome'}, {'id': 'D010300', 'term': 'Parkinson Disease'}], 'ancestors': [{'id': 'D064420', 'term': 'Drug-Related Side Effects and Adverse Reactions'}, {'id': 'D064419', 'term': 'Chemically-Induced Disorders'}, {'id': 'D020734', 'term': 'Parkinsonian Disorders'}, {'id': 'D001480', 'term': 'Basal Ganglia Diseases'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D009069', 'term': 'Movement Disorders'}, {'id': 'D000080874', 'term': 'Synucleinopathies'}, {'id': 'D019636', 'term': 'Neurodegenerative Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000928', 'term': 'Antidepressive Agents'}, {'id': 'C031967', 'term': 'rasagiline'}], 'ancestors': [{'id': 'D011619', 'term': 'Psychotropic Drugs'}, {'id': 'D002491', 'term': 'Central Nervous System Agents'}, {'id': 'D045506', 'term': 'Therapeutic Uses'}, {'id': 'D020228', 'term': 'Pharmacologic Actions'}, {'id': 'D020164', 'term': 'Chemical Actions and Uses'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 1500}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-02', 'completionDateStruct': {'date': '2010-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-02-02', 'studyFirstSubmitDate': '2009-08-06', 'studyFirstSubmitQcDate': '2009-08-07', 'lastUpdatePostDateStruct': {'date': '2017-02-06', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2009-08-10', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The frequency of serotonin toxicity, as determined by the Adjudication Committee will be calculated for each Group. The primary comparison will be Group R+AD vs. Group R and vs. Group AD', 'timeFrame': '9 months'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ["Parkinson's Disease", 'Serotonin Toxicity', 'Rasagiline', 'Antidepressants', 'Chart Review', 'Retrospective'], 'conditions': ['Serotonin Syndrome']}, 'descriptionModule': {'briefSummary': "To identify the occurrence of serotonin toxicity in Parkinson's Disease (PD) patients receiving antidepressant therapy and rasagiline, compared to those receiving rasagiline without antidepressant medications and compared to PD patients receiving antidepressants, but not rasagiline."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Male or female patients with a diagnosis of PD:\n\n* who received rasagiline at any dose, as mono- or adjunct therapy for PD, with concomitant antidepressant medication, OR\n* who received rasagiline at any dose, as mono- or adjunct therapy for PD, without concomitant antidepressant medication, OR\n* who received antidepressant medication and any other dopaminergic anti-PD therapy besides rasagiline or selegiline including dopaminergic agents, anticholinergics, amantadine, deep brain stimulation (DBS), pallidotomy, etc.', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n1. Male or female patients with a diagnosis of PD\n2. Rasagiline treatment as mono- or adjunct therapy for PD with concomitant antidepressant medication (SSRIs, SNRIs, St. John's wort and/or TCAs) at any time during the specified review period, OR Rasagiline treatment as mono- or adjunct therapy for PD without concomitant antidepressant medication (SSRIs, SNRIs, St. John's wort and/or TCAs) at any time during the specified review period. OR Antidepressant therapy (SSRIs, SNRIs, St. John's wort and/or TCAs) and any other dopaminergic anti-PD treatment besides rasagiline or selegiline at any time during the specified review period\n3. Willing to consent to review of office chart and to review of records of ER visits and/or hospitalizations corresponding to the review window, if required\n4. Patients previously participating in a rasagiline clinical trial (and their follow-up protocols) are eligible, provided that they did not receive antidepressant therapy during trial participation.\n5. In addition to the above criteria, each group has specific inclusion criteria stated below:\n\n * Group R+AD: Enrollment in this group requires that patients must have taken rasagiline and an antidepressant (SSRIs, SNRIs, St. John's wort and/or TCAs, regardless of indication) within 14 days of each other (or five weeks, if fluoxetine preceded rasagiline).\n * Group R: Enrollment in this group requires patients must have at least 2 months of rasagiline use.\n * Group AD: Patients must be taking an approved dopaminergic medication for PD. Enrollment in this group requires that patients must have at least 2 months of treatment with an antidepressant medication.\n\nExclusion Criteria:\n\n1. Use of rasagiline for any indication other than PD\n2. Patients taking a monoamine oxidase inhibitor (MAOI) antidepressant and/or selegiline\n3. Inability or unwillingness to request records of ER visits and/or hospitalizations corresponding to the review period."}, 'identificationModule': {'nctId': 'NCT00955604', 'acronym': 'STACCATO', 'briefTitle': 'Azilect + Antidepressant Chart Review', 'organization': {'class': 'INDUSTRY', 'fullName': 'Teva Branded Pharmaceutical Products R&D, Inc.'}, 'officialTitle': "Investigation of the Occurrence of Serotonin Toxicity in Parkinson's Disease (PD) Patients Treated Concomitantly With Rasagiline and Antidepressants, Using Retrospective Chart Review", 'orgStudyIdInfo': {'id': 'TVP-1012/PM102 CR'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Group R+AD', 'description': "Group R+AD Rasagiline and an antidepressant (SRIs, SNRIs, St. John's wort and/or TCAs) for at least 14 days", 'interventionNames': ['Drug: Group R+AD Rasagiline + Antidepressant']}, {'label': 'Group R', 'description': 'At least 2 months of rasagiline', 'interventionNames': ['Drug: Group R Rasagiline']}, {'label': 'Group AD', 'description': 'At least 2 months of Anti-PD and Rasagiline', 'interventionNames': ['Drug: Group AD Anti-PD + Antidepressant']}], 'interventions': [{'name': 'Group R+AD Rasagiline + Antidepressant', 'type': 'DRUG', 'otherNames': ['Azilect'], 'description': "Rasagiline and an antidepressant (SRIs, SNRIs, St. John's wort and/or TCAs) at least 14 days", 'armGroupLabels': ['Group R+AD']}, {'name': 'Group R Rasagiline', 'type': 'DRUG', 'otherNames': ['Azilect'], 'description': 'At least 2 months of rasagiline', 'armGroupLabels': ['Group R']}, {'name': 'Group AD Anti-PD + Antidepressant', 'type': 'DRUG', 'description': 'An approved dopaminergic medication for PD. (2 months of treatment with an antidepressant medication.', 'armGroupLabels': ['Group AD']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Tom Smith, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Teva Neuroscience, Inc.'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Teva Branded Pharmaceutical Products R&D, Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}