The INSYTE (Management of Parkinson's Disease Psychosis in Actual Practice) Study

Management of Parkinson's Disease Psychosis in Actual Practice (The INSYTE Study)

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

Study Overview

• Status: Terminated
• Conditions: Parkinson Disease Psychosis
• Intervention / Treatment: Other: Real-world, non-interventional

• Study Type: Observational
• Enrollment (Actual): 764

Contacts and Locations

Study Locations

• United States
  • Alabama
    • Cullman, Alabama, United States, 35058
      • North Central Neurology Associates, P.C.
  • Alaska
    • Anchorage, Alaska, United States, 99501
      • Peak Neurology and Sleep Medicine, LLC
  • Arizona
    • Scottsdale, Arizona, United States, 85258
      • Movement Disorders Center of Arizona
  • California
    • Laguna Hills, California, United States, 92653
      • Brain and Elective Spine Treatment Center
    • Los Gatos, California, United States, 95032
      • Silicon Valley Parkinson Center Inc.
    • Menlo Park, California, United States, 94025
      • Parkinson's Disease and Movement Disorder of Silicon Valley
    • Northridge, California, United States, 91326
      • Jeri Yvonne Movement Disorders Neurology, Inc.
    • Santa Monica, California, United States, 90404
      • Pacific Movement Disorders Center
  • Colorado
    • Greenwood Village, Colorado, United States, 80111
      • Colorado Neurological Institute
  • Connecticut
    • New Britain, Connecticut, United States, 06053
      • Hospital for Special Care
  • Florida
    • Boca Raton, Florida, United States, 33487
      • SFM Clinical Research, LLC
    • Boca Raton, Florida, United States, 33428
      • Neurology Offices of S. Florina
    • Boca Raton, Florida, United States, 33486
      • Parkinson's Disease and Movement Disorders Center of Boca Raton, Inc.
    • Miami, Florida, United States, 33175
      • Intermed Medical Research Center
    • Port Charlotte, Florida, United States, 33952
      • Ramon A. Gil, MD, PA, DBA Parkinson's Disease Treatment Center of SW Florida
    • Saint Petersburg, Florida, United States, 34309
      • Nova Clinical Research, LLC
  • Georgia
    • Atlanta, Georgia, United States, 30327
      • MS Center of Atlanta
  • Illinois
    • Chicago, Illinois, United States, 60612
      • Rush University Medical Center
    • Glen Carbon, Illinois, United States, 62034
      • Southern Illinois Associates, LLC
    • Winfield, Illinois, United States, 60190
      • Central DuPage Hospital
  • Indiana
    • Avon, Indiana, United States, 46123
      • American Health Network of Indiana
    • Fort Wayne, Indiana, United States, 46804
      • Fort Wayne Neurological Center
  • Kansas
    • Leawood, Kansas, United States, 66206
      • Psychiatry Associates of Kansas City
    • Overland Park, Kansas, United States, 66212
      • Overland Park Surgical Specialties, LLC
  • Louisiana
    • Gray, Louisiana, United States, 70359
      • Southeast Neuroscience Center
    • New Orleans, Louisiana, United States, 70112
      • LSU Health Sciences Center - New Orleans
  • Maine
    • Bangor, Maine, United States, 04401
      • Eastern Maine Medical Center
    • Portland, Maine, United States, 04102
      • Maine Medical Center
  • Maryland
    • Elkridge, Maryland, United States, 21075
      • Parkinsons & Movement Disorders Center of Maryland
  • Massachusetts
    • Boston, Massachusetts, United States, 00211
      • Tufts Medical Center, Inc.
    • Foxboro, Massachusetts, United States, 02035
      • Neurology Center of New England
    • Worcester, Massachusetts, United States, 01655
      • University of Massachusetts, Worcester
  • Michigan
    • East Lansing, Michigan, United States, 48824
      • Michigan State Neurology
    • Farmington Hills, Michigan, United States, 48334
      • The Parkinson's and Movement Disorder Center
    • Traverse City, Michigan, United States, 49684
      • Cornelius Robens, MD, PLLC
    • West Bloomfield, Michigan, United States, 48322
      • Henry Ford Health System
  • Missouri
    • Kansas City, Missouri, United States, 64111
      • Saint Luke's Hospital of Kansas City
  • Nebraska
    • Omaha, Nebraska, United States, 68131
      • Neurology Consultants of Nebraska
  • Nevada
    • Las Vegas, Nevada, United States, 89128
      • Neurology Center of Las Vegas
    • Las Vegas, Nevada, United States, 89104
      • Las Vegas Neurology Center
  • New Jersey
    • Camden, New Jersey, United States, 08103
      • The Cooper Health System
    • Edison, New Jersey, United States, 08820
      • JFK Neuroscience Institute
    • New Brunswick, New Jersey, United States, 08903
      • Rutgers, Robert Wood Johnson
  • New York
    • Amherst, New York, United States, 14226
      • Dent Neurosciences Research Center, Inc.
    • Rochester, New York, United States, 14642
      • University of Rochester Neurology
    • Staten Island, New York, United States, 10306
      • Alpha Neurology PC
    • Valhalla, New York, United States, 10595
      • New York Medical College
  • North Carolina
    • Huntersville, North Carolina, United States, 28078
      • Excel Psychiatric Associates
    • Raleigh, North Carolina, United States, 27607
      • Raleigh Neurology Associates, PA
  • Ohio
    • Akron, Ohio, United States, 44320
      • Neurology and Neuroscience Associates, Inc.
    • Centerville, Ohio, United States, 45459
      • Dayton center for neurological disorders
    • Cleveland, Ohio, United States, 44106
      • University Hospitals Cleveland Medical Center
    • Cuyahoga Falls, Ohio, United States, 44223
      • Renga A. Pakeeree, MD
  • Pennsylvania
    • Allentown, Pennsylvania, United States, 18103
      • Lehigh Valley Health Network
  • Rhode Island
    • East Providence, Rhode Island, United States, 02914
      • Allegheny-Singer Research Institute
  • Texas
    • Baytown, Texas, United States, 77521
      • Jacinto Medical Group
    • Bedford, Texas, United States, 76021
      • North Texas Movement Disorders Institute
    • Sherman, Texas, United States, 75090
      • Texas Institute for Neurological Disorders (Texoma Neurology)
    • Tyler, Texas, United States, 75701
      • East Texas Medical Center Healthcare Associates
    • Tyler, Texas, United States, 75702
      • CHRISTUS Trinity Frances Neuroscience Institute
  • Virginia
    • Arlington, Virginia, United States, 22203
      • Medical Faculty Associates, Inc.
    • Charlottesville, Virginia, United States, 22908
      • University of Virginia
    • Christiansburg, Virginia, United States, 24073
      • Blacksburg Neurology, PC
    • Norfolk, Virginia, United States, 23502
      • Neurology Specialists
    • Richmond, Virginia, United States, 23226
      • Henrico Doctors' Neurology Associates LLC
  • Washington
    • Auburn, Washington, United States, 98002
      • Cascade Surgery Associates, PLLC DBA Northwest Neurology Electrodiagnostic Center
    • Spokane, Washington, United States, 99202
      • Inland Northwest Research, LLC
  • West Virginia
    • Beckley, West Virginia, United States, 25801
      • Vaught Neurological Services, PLLC
  • Wisconsin
    • La Crosse, Wisconsin, United States, 54601
      • Gundersen Lutheran Medical Center, Inc.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients experiencing hallucinations and delusions as a complication of Parkinson's Disease.

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Group 1: Parkinson Disease Psychosis (PDP) patients; PDP patients not treated with an antipsychotic at the time of enrollment	Other: Real-world, non-interventional; N/A - non-interventional
Group 2: Parkinson Disease Psychosis (PDP) patients; PDP patients treated with an antipsychotic (other than NUPLAZID®) at the time of enrollment	Other: Real-world, non-interventional; N/A - non-interventional
Group 3: Parkinson Disease Psychosis (PDP) patients; PDP patients treated with NUPLAZID® at the time of enrollment	Other: Real-world, non-interventional; N/A - non-interventional

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The INSYTE (Management of Parkinson's Disease Psychosis in Actual Practice)	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.	Approximately 36 months

Collaborators and Investigators

• Sponsor: ACADIA Pharmaceuticals Inc.

Study record dates

Study Major Dates

• Study Start (Actual): March 30, 2017
• Primary Completion (Actual): March 8, 2021
• Study Completion (Actual): March 8, 2021

Study Registration Dates

• First Submitted: May 11, 2017
• First Submitted That Met QC Criteria: May 11, 2017
• First Posted (Actual): May 15, 2017

Study Record Updates

• Last Update Posted (Actual): August 6, 2021
• Last Update Submitted That Met QC Criteria: July 30, 2021
• Last Verified: July 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Schizophrenia Spectrum and Other Psychotic Disorders; Parkinsonian Disorders; Basal Ganglia Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases; Psychotic Disorders; Parkinson Disease; Mental Disorders
• Other Study ID Numbers: ACP-NIS-001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No