Conditions: Parkinson's Disease Psychosis
Keywords: Parkinson's disease, psychotic disorders
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 298
Healthy volunteers: no

Brief summary:
This study will evaluate the safety and efficacy of two dose levels of pimavanserin (ACP-103) compared to placebo in patients with Parkinson's disease psychosis.

Detailed description:

Arms:
arm 1: Pimavanserin tartrate (ACP-103), 10 mg, tablet, once daily by mouth, 6 weeks arm 2: Pimavanserin tartrate (ACP-103), 40 mg, tablet, once daily by mouth, 6 weeks arm 3: Placebo tablet, once daily by mouth, 6 weeks

Interventions: intervention 1: Pimavanserin tartrate (ACP-103) intervention 2: Pimavanserin tartrate (ACP-103) intervention 3: Placebo
Intervention descriptions: intervention 1: 10 mg, tablet, once daily by mouth, 6 weeks intervention 2: 40 mg, tablet, once daily by mouth, 6 weeks intervention 3: tablet, once daily by mouth, 6 weeks

Protocol document: