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

Acadia Pharmaceuticals

Status: Terminated

Conditions: Parkinson Disease Psychosis

Treatments: Other: Real-world, non-interventional

Study type: Observational

Funder types: Industry

Identifiers

NCT03152292

ACP-NIS-001

Details and patient eligibility

About

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

Enrollment: 764 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

764 participants in 3 patient groups

Group 1: Parkinson Disease Psychosis (PDP) patients

Description:

PDP patients not treated with an antipsychotic at the time of enrollment

Treatment:

Other: Real-world, non-interventional

Group 2: Parkinson Disease Psychosis (PDP) patients

Description:

PDP patients treated with an antipsychotic (other than NUPLAZID®) at the time of enrollment

Treatment:

Other: Real-world, non-interventional

Group 3: Parkinson Disease Psychosis (PDP) patients

Description:

PDP patients treated with NUPLAZID® at the time of enrollment

Treatment:

Other: Real-world, non-interventional