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Parkinson’s Disease Psychosis Treatment Study

Clinical Trial Title: 
A randomized, parallel-group, multicenter study to evaluate the efficacy, safety, and tolerability of SEP 363856 in subjects with Parkinson’s disease psychosis.
Clinical Trial Protocol ID: 
Clinical Trial Investigator Name: 
Cynthia L. Comella, MD
Clinical Trial Protocol Description: 

This is a multicenter, randomized, parallel-group, doubleblind, placebo-controlled study evaluating the efficacy, safety, and tolerability of SEP-363856 for 6 weeks in male and female subjects ≥ 55 years of age with a clinical diagnosis of Parkinson’s disease psychosis (PDP). The study will randomize approximately 36 subjects to 2 treatment groups in a 2:1 ratio (approximately 24 subjects to SEP-363856 and 12 to placebo). At Rush University Medical Center we expect to recruit approximately 5 patients. The treatment will be assigned randomly.

Clinical Trial Eligibility Criteria: 

In order to participate you must meet the following criteria:

  • Are willing and able (or have a caregiver, and/or legally authorized representative) to sign informed consent to participate in the study.
  • Are willing and able to comply with the study procedures and visit schedules and are able to follow verbal and written instructions.
  • Are male or postmenopausal female ≥ 55 years of age.
  • Meets established diagnostic criteria for Parkinson’s disease of at least one year duration, consistent with the UK Brain Bank criteria.

You will be excluded from the study if any of the following criteria apply to you:

  • Have psychosis secondary to other toxic or metabolic disorders.
  • Have dementia diagnosed concurrent with or before Parkinson’s disease, motor symptoms that began less than one year before the onset of dementia or symptoms consistent with the diagnosis of Lewy Body Dementia (DLB) or if the psychosis occurred after ablative stereotaxic surgery.
  • Have had a stroke or other uncontrolled serious medical or neurological illness Protocol SEP361-203, Version 5.00 SEP-363856 Confidential and Proprietary 8 30 January 2018 within 6 months of baseline.
  • Answer “yes” to “Suicidal Ideation” Item 4 (active suicidal ideation with some intent to act, without specific plan) or Item 5 (active suicidal ideation with specific plan and intent) on the C-SSRS at Screening (ie, in the past one month) or baseline (ie, since last visit).

This is a partial list of inclusion and exclusion criteria.

Clinical Trial Area: 
Parkinson's Disease and Other Movement Disorders
Contact Phone: 
(312) 563-2900 (Press 4; Provide code name: SEP361)
Contact Name: 
Jairo Chavez