Parkinson Disease Clinical Trial
Official title:
Characterization and Progression of Minor Phenomena in Parkinson's Disease
Verified date | March 2024 |
Source | University of Rochester |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
Parkinson's disease psychosis encompasses a range of symptoms, including minor phenomena, frank hallucinations, and delusions. Minor phenomena include passage hallucinations (fleeting sense of a person, animal or object passing in the periphery), presence hallucinations (feeling of nearby presence), and illusions (misrepresentation of external stimuli). Some forms of PD psychosis may be progressive. The primary objective of this study is to: 1) To determine the cumulative probability of developing hallucinations or delusions over time in individuals with PD minor phenomena followed for 36 months.
Status | Completed |
Enrollment | 38 |
Est. completion date | December 31, 2023 |
Est. primary completion date | December 31, 2023 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 30 Years and older |
Eligibility | Inclusion Criteria: - Parkinson's disease (as determined by Movement Disorders Society diagnostic criteria for clinically probable Parkinson's disease) - Parkinson's disease minor phenomena - =30 years of age - Proficient in English - Willing and able to provide informed consent Exclusion Criteria: - Any current or prior history of formed hallucinations or delusions - Current or prior treatment with an antipsychotic medication (regardless of indication) - Diagnosis of mania with psychotic features, bipolar or related disorder, depression with psychotic features, or a psychotic disorder - Unable or unwilling to complete study activities - Any medical or psychiatric comorbidity that, in the opinion of the investigator, would compromise study participation |
Country | Name | City | State |
---|---|---|---|
United States | University of Rochester Medical Center | Rochester | New York |
Lead Sponsor | Collaborator |
---|---|
University of Rochester | ACADIA Pharmaceuticals Inc. |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Cumulative probability of developing hallucinations or delusions over time | Kaplan-Meier curves will be used to describe the cumulative probability of hallucinations and/or delusions over time. Participants will be determined to have met the primary endpoint if they have hallucinations and/or delusions on the basis of interview or initiate treatment with an antipsychotic medication. | baseline to 36 months |
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