A Study of the Safety and Efficacy of Pimavanserin in Patients With Parkinson's Disease Psychosis
Condition: Parkinson's Disease Psychosis
MeSH terms: Parkinson Disease; Psychotic Disorders; Mental Disorders
Intervention: pimavanserin tartrate; placebo
Intervention description: pimavanserin tartrate, 40 mg, tablet, once daily by mouth for 6 weeks; placebo, tablet, once daily by mouth for 6 weeks
Intervention MeSH terms: Pimavanserin
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 199.0
Sex: All
Minimum age: 40 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to evaluate the safety and efficacy of 40 mg pimavanserin
      compared to placebo in patients with Parkinson's disease psychosis (PDP).
    

Eligibility criteria:

        Inclusion Criteria:

          -  A clinical diagnosis of Parkinson's disease with a minimum duration of 1 year

          -  Presence of visual and/or auditory hallucinations, and/or delusions, occurring during
             the four weeks prior to study screening

          -  Psychotic symptoms must have developed after Parkinson's disease diagnosis was
             established

          -  Subjects that are on anti-Parkinson's medication must be on a stable dose for 1 month
             prior to Study Day 1 (Baseline) and during the trial

          -  Subject that has received stereotaxic surgery for subthalamic nucleus deep brain
             stimulation must be at least 6 months post surgery and the stimulator settings must
             have been stable for at least 1 month prior to Study Day 1 (Baseline) and must remain
             stable during the trial

          -  The subject is willing and able to provide consent

          -  Caregiver is willing and able to accompany the subject to all visits

          -  Subject and caregiver are willing and able to adequately communicate in English for
             the purposes of the primary assessment

        Exclusion Criteria:

          -  Subject has a history of significant psychotic disorders prior to or concomitantly
             with the diagnosis of Parkinson's disease including, but not limited to, schizophrenia
             or bipolar disorder

          -  Subject has received previous ablative stereotaxic surgery (i.e., pallidotomy and
             thalamotomy) to treat Parkinson's disease

          -  Subject has current evidence of a serious and or unstable cardiovascular, respiratory,
             gastrointestinal, renal, hematologic or other medical disorder

          -  Subject has had a myocardial infarction in last six months

          -  Subject has any surgery planned during the screening, treatment or follow-up periods

        Patients will be evaluated at screening to ensure that all criteria for study participation
        are met. These evaluations will include specific measures of psychosis severity, delirium,
        dementia, cardiovascular condition, and pregnancy status. Patients may be excluded from the
        study based on these assessments (and specifically if it is determined that their baseline
        health and psychiatric condition do not meet all protocol-specified entry criteria).