Parkinson Disease PsychosisNCT03152292
The INSYTE (Management of Parkinson's Disease Psychosis in Actual Practice) Study
An observational study of Parkinson Disease Psychosis, run by ACADIA Pharmaceuticals Inc. at 69 sites in United States.
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 Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Parkinson Disease Psychosis
- What is being tested?
- Real-world, non-interventional
- How many people
- 764 participants
- Where
- 69 sitesUnited States
- Study dates
- 30 Mar 2017to 8 Mar 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients experiencing hallucinations and delusions as a complication of Parkinson's Disease.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
69 sites in 1 country.
69 sites in 1 country
United States69 sites
Neurology and Neuroscience Associates, Inc.
Akron, Ohio, 44320
Lehigh Valley Health Network
Allentown, Pennsylvania, 18103
Dent Neurosciences Research Center, Inc.
Amherst, New York, 14226
Peak Neurology and Sleep Medicine, LLC
Anchorage, Alaska, 99501
Medical Faculty Associates, Inc.
Arlington, Virginia, 22203
MS Center of Atlanta
Atlanta, Georgia, 30327
Cascade Surgery Associates, PLLC DBA Northwest Neurology Electrodiagnostic Center
Auburn, Washington, 98002
American Health Network of Indiana
Avon, Indiana, 46123
Eastern Maine Medical Center
Bangor, Maine, 04401
Jacinto Medical Group
Baytown, Texas, 77521
Vaught Neurological Services, PLLC
Beckley, West Virginia, 25801
North Texas Movement Disorders Institute
Bedford, Texas, 76021
Neurology Offices of S. Florina
Boca Raton, Florida, 33428
Parkinson's Disease and Movement Disorders Center of Boca Raton, Inc.
Boca Raton, Florida, 33486
SFM Clinical Research, LLC
Boca Raton, Florida, 33487
Tufts Medical Center, Inc.
Boston, Massachusetts, 00211
The Cooper Health System
Camden, New Jersey, 08103
Dayton Center for Neurological Disorders
Centerville, Ohio, 45459
University of Virginia
Charlottesville, Virginia, 22908
Rush University Medical Center
Chicago, Illinois, 60612
Blacksburg Neurology, PC
Christiansburg, Virginia, 24073
University Hospitals Cleveland Medical Center
Cleveland, Ohio, 44106
North Central Neurology Associates, P.C.
Cullman, Alabama, 35058
Renga A. Pakeeree, MD
Cuyahoga Falls, Ohio, 44223
Michigan State Neurology
East Lansing, Michigan, 48824
Allegheny-Singer Research Institute
East Providence, Rhode Island, 02914
JFK Neuroscience Institute
Edison, New Jersey, 08820
Parkinsons & Movement Disorders Center of Maryland
Elkridge, Maryland, 21075
The Parkinson's and Movement Disorder Center
Farmington Hills, Michigan, 48334
Fort Wayne Neurological Center
Fort Wayne, Indiana, 46804
Neurology Center of New England
Foxborough, Massachusetts, 02035
Southern Illinois Associates, LLC
Glen Carbon, Illinois, 62034
Southeast Neuroscience Center
Gray, Louisiana, 70359
Colorado Neurological Institute
Greenwood Village, Colorado, 80111
Excel Psychiatric Associates
Huntersville, North Carolina, 28078
Saint Luke's Hospital of Kansas City
Kansas City, Missouri, 64111
Gundersen Lutheran Medical Center, Inc.
La Crosse, Wisconsin, 54601
Brain and Elective Spine Treatment Center
Laguna Hills, California, 92653
Las Vegas Neurology Center
Las Vegas, Nevada, 89104
Neurology Center of Las Vegas
Las Vegas, Nevada, 89128
Psychiatry Associates of Kansas City
Leawood, Kansas, 66206
Silicon Valley Parkinson Center Inc.
Los Gatos, California, 95032
Parkinson's Disease and Movement Disorder of Silicon Valley
Menlo Park, California, 94025
Intermed Medical Research Center
Miami, Florida, 33175
Hospital for Special Care
New Britain, Connecticut, 06053
Rutgers, Robert Wood Johnson
New Brunswick, New Jersey, 08903
LSU Health Sciences Center - New Orleans
New Orleans, Louisiana, 70112
Neurology Specialists
Norfolk, Virginia, 23502
Jeri Yvonne Movement Disorders Neurology, Inc.
Northridge, California, 91326
Neurology Consultants of Nebraska
Omaha, Nebraska, 68131
Overland Park Surgical Specialties, LLC
Overland Park, Kansas, 66212
Ramon A. Gil, MD, PA, DBA Parkinson's Disease Treatment Center of SW Florida
Port Charlotte, Florida, 33952
Maine Medical Center
Portland, Maine, 04102
Raleigh Neurology Associates, PA
Raleigh, North Carolina, 27607
Henrico Doctors' Neurology Associates LLC
Richmond, Virginia, 23226
University of Rochester Neurology
Rochester, New York, 14642
Pacific Movement Disorders Center
Santa Monica, California, 90404
Movement Disorders Center of Arizona
Scottsdale, Arizona, 85258
Texas Institute for Neurological Disorders (Texoma Neurology)
Sherman, Texas, 75090
Inland Northwest Research, LLC
Spokane, Washington, 99202
NOVA Clinical Research, LLC
St. Petersburg, Florida, 34309
Alpha Neurology PC
Staten Island, New York, 10306
Cornelius Robens, MD, PLLC
Traverse City, Michigan, 49684
East Texas Medical Center Healthcare Associates
Tyler, Texas, 75701
CHRISTUS Trinity Frances Neuroscience Institute
Tyler, Texas, 75702
New York Medical College
Valhalla, New York, 10595
Henry Ford Health System
West Bloomfield, Michigan, 48322
Central DuPage Hospital
Winfield, Illinois, 60190
University of Massachusetts, Worcester
Worcester, Massachusetts, 01655
About this study
Official title: 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
- Conditions
- Parkinson Disease Psychosis
- Being tested
- Real-world, non-interventional
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Real-world, non-interventionalOther
N/A - non-interventional
| Study group | Role | What they receive |
|---|---|---|
| Group 1: Parkinson Disease Psychosis (PDP) patients | PDP patients not treated with an antipsychotic at the time of enrollment Receives: Other: Real-world, non-interventional | |
| Group 2: Parkinson Disease Psychosis (PDP) patients | PDP patients treated with an antipsychotic (other than NUPLAZID®) at the time of enrollment Receives: Other: Real-world, non-interventional | |
| Group 3: Parkinson Disease Psychosis (PDP) patients | PDP patients treated with NUPLAZID® at the time of enrollment Receives: Other: Real-world, non-interventional |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Approximately 36 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 May 2017
- Study start30 Mar 2017
- Primary completion8 Mar 2021
- Study completion8 Mar 2021
Why it stopped: Study follow-up duration impacted by COVID-19pandemic and Sponsor terminated for business reasons
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Parkinson Disease PsychosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 764 participants (actual)
Sponsor and investigators
- Lead sponsor
- ACADIA Pharmaceuticals Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03152292
- Sponsor's protocol ID
- ACP-NIS-001
- Status last verified
- Jul 2021
- First submitted
- 11 May 2017
- Last updated
- 6 Aug 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Management of Parkinson's Disease Psychosis in Actual Practice (The INSYTE Study)
- ClinicalTrials.gov ID
- NCT03152292
- Acronym / sponsor ID
- ACP-NIS-001
- Conditions
- Parkinson Disease Psychosis
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Study follow-up duration impacted by COVID-19pandemic and Sponsor terminated for business reasons
- Enrolment
- 764 participants (actual)
- Lead sponsor
- ACADIA Pharmaceuticals Inc.Industry (pharma, biotech, devices)
- Study start
- 30 Mar 2017 (actual)
- Primary completion
- 8 Mar 2021 (actual)
- Study completion
- 8 Mar 2021 (actual)
- First posted
- 15 May 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Group 1: Parkinson Disease Psychosis (PDP) patients | – | Other: Real-world, non-interventionalPDP patients not treated with an antipsychotic at the time of enrollment |
| Group 2: Parkinson Disease Psychosis (PDP) patients | – | Other: Real-world, non-interventionalPDP patients treated with an antipsychotic (other than NUPLAZID®) at the time of enrollment |
| Group 3: Parkinson Disease Psychosis (PDP) patients | – | Other: Real-world, non-interventionalPDP patients treated with NUPLAZID® at the time of enrollment |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients experiencing hallucinations and delusions as a complication of Parkinson's Disease.
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (2 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Real-world, non-interventionalN/A - non-interventional | Other | Group 1: Parkinson Disease Psychosis (PDP) patients, Group 2: Parkinson Disease Psychosis (PDP) patients, Group 3: Parkinson Disease Psychosis (PDP) patients |
Primary outcome
The INSYTE (Management of Parkinson's Disease Psychosis in Actual Practice)
Time frame: 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.
Results and safety
The study was stopped early (reason given: Study follow-up duration impacted by COVID-19pandemic and Sponsor terminated for business reasons). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Aug 2021.
- Individual participant dataSharing planned: No
Related trials for Parkinson Disease Psychosis
Active, not recruitingPhase 2
Clinical Trial Evaluating the Efficacy and Safety of AGB101 for Treatment of Parkinson's Disease Related Psychosis
Parkinson Disease Psychosis
RecruitingPhase 4
Pimavanserin vs. Quetiapine for Treatment of Parkinson's Psychosis
Parkinson's Disease Psychosis
RecruitingPhase 4
Characterization of the Serotonin 2A Receptor Selective PET Tracer [18F]MH.MZ in Patients With Neurodegenerative Diseases
Neurodegenerative Diseases, Parkinson Disease
Recruiting
Ultra-High Resolution PET in Aging, Neurodegeneration and Psychotic Disorders
Alzheimer Dementia (AD), ALS - Amyotrophic Lateral Sclerosis
Recruiting
Cerebellar Stimulation and Cognitive Control
Schizophrenia, Autism Spectrum Disorder
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
69 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Parkinson Disease Psychosis, run by ACADIA Pharmaceuticals Inc. at 69 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 6 Aug 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 69 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Study follow-up duration impacted by COVID-19pandemic and Sponsor terminated for business reasons). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The INSYTE (Management of Parkinson's Disease Psychosis in Actual Practice) (time frame: Approximately 36 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Aug 2021.