The INSYTE (Management of Parkinson's Disease Psychosis in Actual Practice) Study
- Conditions
- Parkinson Disease Psychosis
- Interventions
- Other: Real-world, non-interventional
- Registration Number
- NCT03152292
- Lead Sponsor
- ACADIA Pharmaceuticals Inc.
- Brief Summary
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
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 764
- Adult males and females ≥ 18 with PDP
- Ability to understand and read English
- 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
- Possess the symptoms commonly associated with PDP, e.g., hallucinations and delusions that cannot be reasonably attributed to other causes
- Patient is unwilling to participate in the non-interventional study
- Patient is currently participating in or is planning to participate in an investigational clinical trial
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Group 1: Parkinson Disease Psychosis (PDP) patients Real-world, non-interventional PDP patients not treated with an antipsychotic at the time of enrollment Group 3: Parkinson Disease Psychosis (PDP) patients Real-world, non-interventional PDP patients treated with NUPLAZID® at the time of enrollment Group 2: Parkinson Disease Psychosis (PDP) patients Real-world, non-interventional PDP patients treated with an antipsychotic (other than NUPLAZID®) at the time of enrollment
- Primary Outcome Measures
Name Time Method The INSYTE (Management of Parkinson's Disease Psychosis in Actual Practice) Approximately 36 months Describe the safety and effectiveness of antipsychotic therapies and other treatment approaches in the management of PDP. Describe comparative clinical, economic, and humanistic outcomes of treatment approaches for both patients and caregivers, in the context of real-world medical practice settings.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (69)
New York Medical College
🇺🇸Valhalla, New York, United States
MS Center of Atlanta
🇺🇸Atlanta, Georgia, United States
Alpha Neurology PC
🇺🇸Staten Island, New York, United States
Hospital for Special Care
🇺🇸New Britain, Connecticut, United States
Rush University Medical Center
🇺🇸Chicago, Illinois, United States
Jeri Yvonne Movement Disorders Neurology, Inc.
🇺🇸Northridge, California, United States
Ramon A. Gil, MD, PA, DBA Parkinson's Disease Treatment Center of SW Florida
🇺🇸Port Charlotte, Florida, United States
Eastern Maine Medical Center
🇺🇸Bangor, Maine, United States
Central DuPage Hospital
🇺🇸Winfield, Illinois, United States
Michigan State Neurology
🇺🇸East Lansing, Michigan, United States
Southeast Neuroscience Center
🇺🇸Gray, Louisiana, United States
NOVA Clinical Research, LLC
🇺🇸Saint Petersburg, Florida, United States
Neurology Consultants of Nebraska
🇺🇸Omaha, Nebraska, United States
The Parkinson's and Movement Disorder Center
🇺🇸Farmington Hills, Michigan, United States
North Central Neurology Associates, P.C.
🇺🇸Cullman, Alabama, United States
Colorado Neurological Institute
🇺🇸Greenwood Village, Colorado, United States
Parkinson's Disease and Movement Disorders Center of Boca Raton, Inc.
🇺🇸Boca Raton, Florida, United States
Fort Wayne Neurological Center
🇺🇸Fort Wayne, Indiana, United States
American Health Network of Indiana
🇺🇸Avon, Indiana, United States
Psychiatry Associates of Kansas City
🇺🇸Leawood, Kansas, United States
Cascade Surgery Associates, PLLC DBA Northwest Neurology Electrodiagnostic Center
🇺🇸Auburn, Washington, United States
Brain and Elective Spine Treatment Center
🇺🇸Laguna Hills, California, United States
LSU Health Sciences Center - New Orleans
🇺🇸New Orleans, Louisiana, United States
Neurology Center of New England
🇺🇸Foxboro, Massachusetts, United States
Overland Park Surgical Specialties, LLC
🇺🇸Overland Park, Kansas, United States
Gundersen Lutheran Medical Center, Inc.
🇺🇸La Crosse, Wisconsin, United States
University of Rochester Neurology
🇺🇸Rochester, New York, United States
Allegheny-Singer Research Institute
🇺🇸East Providence, Rhode Island, United States
Medical Faculty Associates, Inc.
🇺🇸Arlington, Virginia, United States
Lehigh Valley Health Network
🇺🇸Allentown, Pennsylvania, United States
Raleigh Neurology Associates, PA
🇺🇸Raleigh, North Carolina, United States
Dayton Center for Neurological Disorders
🇺🇸Centerville, Ohio, United States
Parkinsons & Movement Disorders Center of Maryland
🇺🇸Elkridge, Maryland, United States
Intermed Medical Research Center
🇺🇸Miami, Florida, United States
Tufts Medical Center, Inc.
🇺🇸Boston, Massachusetts, United States
Blacksburg Neurology, PC
🇺🇸Christiansburg, Virginia, United States
Peak Neurology and Sleep Medicine, LLC
🇺🇸Anchorage, Alaska, United States
Movement Disorders Center of Arizona
🇺🇸Scottsdale, Arizona, United States
Parkinson's Disease and Movement Disorder of Silicon Valley
🇺🇸Menlo Park, California, United States
Silicon Valley Parkinson Center Inc.
🇺🇸Los Gatos, California, United States
Pacific Movement Disorders Center
🇺🇸Santa Monica, California, United States
Neurology Offices of S. Florina
🇺🇸Boca Raton, Florida, United States
SFM Clinical Research, LLC
🇺🇸Boca Raton, Florida, United States
Southern Illinois Associates, LLC
🇺🇸Glen Carbon, Illinois, United States
Cornelius Robens, MD, PLLC
🇺🇸Traverse City, Michigan, United States
Dent Neurosciences Research Center, Inc.
🇺🇸Amherst, New York, United States
Renga A. Pakeeree, MD
🇺🇸Cuyahoga Falls, Ohio, United States
Texas Institute for Neurological Disorders (Texoma Neurology)
🇺🇸Sherman, Texas, United States
University of Virginia
🇺🇸Charlottesville, Virginia, United States
Vaught Neurological Services, PLLC
🇺🇸Beckley, West Virginia, United States
Inland Northwest Research, LLC
🇺🇸Spokane, Washington, United States
Henry Ford Health System
🇺🇸West Bloomfield, Michigan, United States
Neurology Center of Las Vegas
🇺🇸Las Vegas, Nevada, United States
Maine Medical Center
🇺🇸Portland, Maine, United States
Las Vegas Neurology Center
🇺🇸Las Vegas, Nevada, United States
Excel Psychiatric Associates
🇺🇸Huntersville, North Carolina, United States
Rutgers, Robert Wood Johnson
🇺🇸New Brunswick, New Jersey, United States
University of Massachusetts, Worcester
🇺🇸Worcester, Massachusetts, United States
Saint Luke's Hospital of Kansas City
🇺🇸Kansas City, Missouri, United States
The Cooper Health System
🇺🇸Camden, New Jersey, United States
University Hospitals Cleveland Medical Center
🇺🇸Cleveland, Ohio, United States
JFK Neuroscience Institute
🇺🇸Edison, New Jersey, United States
Neurology and Neuroscience Associates, Inc.
🇺🇸Akron, Ohio, United States
Jacinto Medical Group
🇺🇸Baytown, Texas, United States
North Texas Movement Disorders Institute
🇺🇸Bedford, Texas, United States
East Texas Medical Center Healthcare Associates
🇺🇸Tyler, Texas, United States
CHRISTUS Trinity Frances Neuroscience Institute
🇺🇸Tyler, Texas, United States
Henrico Doctors' Neurology Associates LLC
🇺🇸Richmond, Virginia, United States
Neurology Specialists
🇺🇸Norfolk, Virginia, United States