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

Parkinson Disease Psychosis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03152292
• Other study ID #: ACP-NIS-001
• Status: Terminated
• Start date: March 30, 2017
• Est. completion date: March 8, 2021

Study information

• Verified date: July 2021
• Source: ACADIA Pharmaceuticals Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 764
• Est. completion date: March 8, 2021
• Est. primary completion date: March 8, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Mental Disorders
• Parkinson Disease
• Parkinson Disease Psychosis
• Psychotic Disorders

Intervention

Other:
• Real-world, non-interventional
N/A - non-interventional

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
ACADIA Pharmaceuticals Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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