Ignite Creation Date:
2025-12-24 @ 3:27 PM
Ignite Modification Date:
2026-03-05 @ 4:55 PM
Study NCT ID:
NCT03152292
Status:
TERMINATED
Last Update Posted:
2021-08-06
First Post:
2017-05-11
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The INSYTE (Management of Parkinson's Disease Psychosis in Actual Practice) Study
Sponsor:
Organization:
Raw JSON
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Describe comparative clinical, economic, and humanistic outcomes of treatment approaches for both patients and caregivers, in the context of real-world medical practice settings.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Parkinson Disease Psychosis']}, 'descriptionModule': {'briefSummary': 'To examine the current disease progression of PDP, the clinical, economic, and humanistic impact of anti-psychotic therapy in the management of the condition in real-world settings, and the burden of the condition on patients and their caregivers'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': "Patients experiencing hallucinations and delusions as a complication of Parkinson's Disease.", 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n1. Adult males and females ≥ 18 with PDP\n2. Ability to understand and read English\n3. Patient is willing and able to sign an Informed Consent Form (ICF), or have a Legally Authorized Representative willing and able to consent on the patient's behalf\n4. Possess the symptoms commonly associated with PDP, e.g., hallucinations and delusions that cannot be reasonably attributed to other causes\n\nExclusion Criteria:\n\n1. Patient is unwilling to participate in the non-interventional study\n2. Patient is currently participating in or is planning to participate in an investigational clinical trial"}, 'identificationModule': {'nctId': 'NCT03152292', 'briefTitle': "The INSYTE (Management of Parkinson's Disease Psychosis in Actual Practice) Study", 'organization': {'class': 'INDUSTRY', 'fullName': 'ACADIA Pharmaceuticals Inc.'}, 'officialTitle': "Management of Parkinson's Disease Psychosis in Actual Practice (The INSYTE Study)", 'orgStudyIdInfo': {'id': 'ACP-NIS-001'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Group 1: Parkinson Disease Psychosis (PDP) patients', 'description': 'PDP patients not treated with an antipsychotic at the time of enrollment', 'interventionNames': ['Other: Real-world, non-interventional']}, {'label': 'Group 2: Parkinson Disease Psychosis (PDP) patients', 'description': 'PDP patients treated with an antipsychotic (other than NUPLAZID®) at the time of enrollment', 'interventionNames': ['Other: Real-world, non-interventional']}, {'label': 'Group 3: Parkinson Disease Psychosis (PDP) patients', 'description': 'PDP patients treated with NUPLAZID® at the time of enrollment', 'interventionNames': ['Other: Real-world, non-interventional']}], 'interventions': [{'name': 'Real-world, non-interventional', 'type': 'OTHER', 'description': 'N/A - non-interventional', 'armGroupLabels': ['Group 1: Parkinson Disease Psychosis (PDP) patients', 'Group 2: Parkinson Disease Psychosis (PDP) patients', 'Group 3: Parkinson Disease Psychosis (PDP) patients']}]}, 'contactsLocationsModule': {'locations': [{'zip': '35058', 'city': 'Cullman', 'state': 'Alabama', 'country': 'United States', 'facility': 'North Central Neurology Associates, P.C.', 'geoPoint': {'lat': 34.17482, 'lon': -86.84361}}, {'zip': '99501', 'city': 'Anchorage', 'state': 'Alaska', 'country': 'United States', 'facility': 'Peak Neurology and Sleep Medicine, LLC', 'geoPoint': {'lat': 61.21806, 'lon': -149.90028}}, {'zip': '85258', 'city': 'Scottsdale', 'state': 'Arizona', 'country': 'United States', 'facility': 'Movement Disorders Center of Arizona', 'geoPoint': {'lat': 33.50921, 'lon': -111.89903}}, {'zip': '92653', 'city': 'Laguna Hills', 'state': 'California', 'country': 'United States', 'facility': 'Brain and Elective Spine Treatment Center', 'geoPoint': {'lat': 33.61252, 'lon': -117.71283}}, {'zip': '95032', 'city': 'Los Gatos', 'state': 'California', 'country': 'United States', 'facility': 'Silicon Valley Parkinson Center Inc.', 'geoPoint': {'lat': 37.22661, 'lon': -121.97468}}, {'zip': '94025', 'city': 'Menlo Park', 'state': 'California', 'country': 'United States', 'facility': "Parkinson's Disease and Movement Disorder of Silicon Valley", 'geoPoint': {'lat': 37.45383, 'lon': -122.18219}}, {'zip': '91326', 'city': 'Northridge', 'state': 'California', 'country': 'United States', 'facility': 'Jeri Yvonne Movement Disorders Neurology, Inc.', 'geoPoint': {'lat': 34.22834, 'lon': -118.53675}}, {'zip': '90404', 'city': 'Santa Monica', 'state': 'California', 'country': 'United States', 'facility': 'Pacific Movement Disorders Center', 'geoPoint': {'lat': 34.01949, 'lon': -118.49138}}, {'zip': '80111', 'city': 'Greenwood Village', 'state': 'Colorado', 'country': 'United States', 'facility': 'Colorado Neurological Institute', 'geoPoint': {'lat': 39.61721, 'lon': -104.95081}}, {'zip': '06053', 'city': 'New Britain', 'state': 'Connecticut', 'country': 'United States', 'facility': 'Hospital for Special Care', 'geoPoint': {'lat': 41.66121, 'lon': -72.77954}}, {'zip': '33428', 'city': 'Boca Raton', 'state': 'Florida', 'country': 'United States', 'facility': 'Neurology Offices of S. 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