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

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

Status
Terminated
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03152292
Enrollment
764
Registered
2017-05-15
Start date
2017-03-30
Completion date
2021-03-08
Last updated
2021-08-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Parkinson Disease Psychosis

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

Interventions

OTHERReal-world, non-interventional

N/A - non-interventional

Sponsors

ACADIA Pharmaceuticals Inc.
Lead SponsorINDUSTRY

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
The INSYTE (Management of Parkinson's Disease Psychosis in Actual Practice)Approximately 36 monthsDescribe 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.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026