Clinical trial NCT03152292: The INSYTE (Management of Parkinson's Disease Psychosis in Actual Practice) Study
Official title: Management of Parkinson's Disease Psychosis in Actual Practice (The INSYTE Study)
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Parkinson Disease Psychosis
Lead sponsor: ACADIA Pharmaceuticals Inc.
Sponsor class: INDUSTRY
First posted: 2017-05-15
Enrollment: 764
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients experiencing hallucinations and delusions as a complication of Parkinson's Disease.

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


Eligibility criteria: Inclusion Criteria:

1. Adult males and females ≥ 18 with PDP
2. Ability to understand and read English
3. 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
4. Possess the symptoms commonly associated with PDP, e.g., hallucinations and delusions that cannot be reasonably attributed to other causes

Exclusion Criteria:

1. Patient is unwilling to participate in the non-interventional study
2. Patient is currently participating in or is planning to participate in an investigational clinical trial

Primary outcomes:
measure: The INSYTE (Management of Parkinson's Disease Psychosis in Actual Practice)
timeFrame: Approximately 36 months
Secondary outcomes:
Other outcomes:
Locations:
city: Cullman
country: United States
facility: North Central Neurology Associates, P.C.
state: Alabama
city: Anchorage
country: United States
facility: Peak Neurology and Sleep Medicine, LLC
state: Alaska
city: Scottsdale
country: United States
facility: Movement Disorders Center of Arizona
state: Arizona
city: Laguna Hills
country: United States
facility: Brain and Elective Spine Treatment Center
state: California
city: Los Gatos
country: United States
facility: Silicon Valley Parkinson Center Inc.
state: California
city: Menlo Park
country: United States
facility: Parkinson's Disease and Movement Disorder of Silicon Valley
state: California
city: Northridge
country: United States
facility: Jeri Yvonne Movement Disorders Neurology, Inc.
state: California
city: Santa Monica
country: United States
facility: Pacific Movement Disorders Center
state: California
city: Greenwood Village
country: United States
facility: Colorado Neurological Institute
state: Colorado
city: New Britain
country: United States
facility: Hospital for Special Care
state: Connecticut
city: Boca Raton
country: United States
facility: Neurology Offices of S. Florina
state: Florida
city: Boca Raton
country: United States
facility: Parkinson's Disease and Movement Disorders Center of Boca Raton, Inc.
state: Florida
city: Boca Raton
country: United States
facility: SFM Clinical Research, LLC
state: Florida
city: Miami
country: United States
facility: Intermed Medical Research Center
state: Florida
city: Port Charlotte
country: United States
facility: Ramon A. Gil, MD, PA, DBA Parkinson's Disease Treatment Center of SW Florida
state: Florida
city: Saint Petersburg
country: United States
facility: NOVA Clinical Research, LLC
state: Florida
city: Atlanta
country: United States
facility: MS Center of Atlanta
state: Georgia
city: Chicago
country: United States
facility: Rush University Medical Center
state: Illinois
city: Glen Carbon
country: United States
facility: Southern Illinois Associates, LLC
state: Illinois
city: Winfield
country: United States
facility: Central DuPage Hospital
state: Illinois
city: Avon
country: United States
facility: American Health Network of Indiana
state: Indiana
city: Fort Wayne
country: United States
facility: Fort Wayne Neurological Center
state: Indiana
city: Leawood
country: United States
facility: Psychiatry Associates of Kansas City
state: Kansas
city: Overland Park
country: United States
facility: Overland Park Surgical Specialties, LLC
state: Kansas
city: Gray
country: United States
facility: Southeast Neuroscience Center
state: Louisiana
city: New Orleans
country: United States
facility: LSU Health Sciences Center - New Orleans
state: Louisiana
city: Bangor
country: United States
facility: Eastern Maine Medical Center
state: Maine
city: Portland
country: United States
facility: Maine Medical Center
state: Maine
city: Elkridge
country: United States
facility: Parkinsons & Movement Disorders Center of Maryland
state: Maryland
city: Boston
country: United States
facility: Tufts Medical Center, Inc.
state: Massachusetts
city: Foxboro
country: United States
facility: Neurology Center of New England
state: Massachusetts
city: Worcester
country: United States
facility: University of Massachusetts, Worcester
state: Massachusetts
city: East Lansing
country: United States
facility: Michigan State Neurology
state: Michigan
city: Farmington Hills
country: United States
facility: The Parkinson's and Movement Disorder Center
state: Michigan
city: Traverse City
country: United States
facility: Cornelius Robens, MD, PLLC
state: Michigan
city: West Bloomfield
country: United States
facility: Henry Ford Health System
state: Michigan
city: Kansas City
country: United States
facility: Saint Luke's Hospital of Kansas City
state: Missouri
city: Omaha
country: United States
facility: Neurology Consultants of Nebraska
state: Nebraska
city: Las Vegas
country: United States
facility: Las Vegas Neurology Center
state: Nevada
city: Las Vegas
country: United States
facility: Neurology Center of Las Vegas
state: Nevada
city: Camden
country: United States
facility: The Cooper Health System
state: New Jersey
city: Edison
country: United States
facility: JFK Neuroscience Institute
state: New Jersey
city: New Brunswick
country: United States
facility: Rutgers, Robert Wood Johnson
state: New Jersey
city: Amherst
country: United States
facility: Dent Neurosciences Research Center, Inc.
state: New York
city: Rochester
country: United States
facility: University of Rochester Neurology
state: New York
city: Staten Island
country: United States
facility: Alpha Neurology PC
state: New York
city: Valhalla
country: United States
facility: New York Medical College
state: New York
city: Huntersville
country: United States
facility: Excel Psychiatric Associates
state: North Carolina
city: Raleigh
country: United States
facility: Raleigh Neurology Associates, PA
state: North Carolina
city: Akron
country: United States
facility: Neurology and Neuroscience Associates, Inc.
state: Ohio
city: Centerville
country: United States
facility: Dayton Center for Neurological Disorders
state: Ohio
city: Cleveland
country: United States
facility: University Hospitals Cleveland Medical Center
state: Ohio
city: Cuyahoga Falls
country: United States
facility: Renga A. Pakeeree, MD
state: Ohio
city: Allentown
country: United States
facility: Lehigh Valley Health Network
state: Pennsylvania
city: East Providence
country: United States
facility: Allegheny-Singer Research Institute
state: Rhode Island
city: Baytown
country: United States
facility: Jacinto Medical Group
state: Texas
city: Bedford
country: United States
facility: North Texas Movement Disorders Institute
state: Texas
city: Sherman
country: United States
facility: Texas Institute for Neurological Disorders (Texoma Neurology)
state: Texas
city: Tyler
country: United States
facility: East Texas Medical Center Healthcare Associates
state: Texas
city: Tyler
country: United States
facility: CHRISTUS Trinity Frances Neuroscience Institute
state: Texas
city: Arlington
country: United States
facility: Medical Faculty Associates, Inc.
state: Virginia
city: Charlottesville
country: United States
facility: University of Virginia
state: Virginia
city: Christiansburg
country: United States
facility: Blacksburg Neurology, PC
state: Virginia
city: Norfolk
country: United States
facility: Neurology Specialists
state: Virginia
city: Richmond
country: United States
facility: Henrico Doctors' Neurology Associates LLC
state: Virginia
city: Auburn
country: United States
facility: Cascade Surgery Associates, PLLC DBA Northwest Neurology Electrodiagnostic Center
state: Washington
city: Spokane
country: United States
facility: Inland Northwest Research, LLC
state: Washington
city: Beckley
country: United States
facility: Vaught Neurological Services, PLLC
state: West Virginia
city: La Crosse
country: United States
facility: Gundersen Lutheran Medical Center, Inc.
state: Wisconsin
Study officials:
References: