ClinicalTrials.gov
ClinicalTrials.gov Menu

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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03152292
Recruitment Status : Recruiting
First Posted : May 15, 2017
Last Update Posted : November 5, 2018
Sponsor:
Information provided by (Responsible Party):
ACADIA Pharmaceuticals Inc.

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 Type : Observational
Estimated Enrollment : 750 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
Estimated Primary Completion Date : September 2021
Estimated Study Completion Date : September 2021

Resource links provided by the National Library of Medicine


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




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.



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.


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

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


Contacts
Contact: Andrew Shim, PharmD 858-261-2779 ashim@acadia-pharm.com

  Show 76 Study Locations
Sponsors and Collaborators
ACADIA Pharmaceuticals Inc.

Responsible Party: ACADIA Pharmaceuticals Inc.
ClinicalTrials.gov Identifier: NCT03152292     History of Changes
Other Study ID Numbers: ACP-NIS-001
First Posted: May 15, 2017    Key Record Dates
Last Update Posted: November 5, 2018
Last Verified: November 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Psychotic Disorders
Mental Disorders
Schizophrenia Spectrum and Other Psychotic Disorders
Parkinson Disease
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Movement Disorders
Neurodegenerative Diseases