We're building a better ClinicalTrials.gov. Check it out and tell us what you think!
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 1 of 1 for:    INSYTE ACP-NIS-001
Previous Study | Return to List | Next Study

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03152292
Recruitment Status : Terminated (Study follow-up duration impacted by COVID-19pandemic and Sponsor terminated for business reasons)
First Posted : May 15, 2017
Last Update Posted : August 6, 2021
Sponsor:
Information provided by (Responsible Party):
ACADIA Pharmaceuticals Inc.

Study Description
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
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

Condition or disease Intervention/treatment
Parkinson Disease Psychosis Other: Real-world, non-interventional

Study Design
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Observational
Actual Enrollment : 764 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Management of Parkinson's Disease Psychosis in Actual Practice (The INSYTE Study)
Actual Study Start Date : March 30, 2017
Actual Primary Completion Date : March 8, 2021
Actual Study Completion Date : March 8, 2021

Resource links provided by the National Library of Medicine


Groups and Cohorts
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

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


Outcome Measures
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. 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.


Eligibility Criteria
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients experiencing hallucinations and delusions as a complication of Parkinson's Disease.
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
Contacts and Locations
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03152292


Locations
Show Show 69 study locations
Sponsors and Collaborators
ACADIA Pharmaceuticals Inc.
More Information
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
Layout table for additonal information
Responsible Party: ACADIA Pharmaceuticals Inc.
ClinicalTrials.gov Identifier: NCT03152292    
Other Study ID Numbers: ACP-NIS-001
First Posted: May 15, 2017    Key Record Dates
Last Update Posted: August 6, 2021
Last Verified: July 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Parkinson Disease
Psychotic Disorders
Mental Disorders
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
 Central Nervous System Diseases
Nervous System Diseases
Movement Disorders
Synucleinopathies
Neurodegenerative Diseases
Schizophrenia Spectrum and Other Psychotic Disorders