Characterization and Progression of Minor Phenomena in Parkinson's Disease (PD)

Parkinson Disease Clinical Trial

Official title:

Characterization and Progression of Minor Phenomena in Parkinson's Disease

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05240339
• Other study ID #: STUDY00003440
• Status: Completed
• Start date: April 25, 2019
• Est. completion date: December 31, 2023

Study information

• Verified date: March 2024
• Source: University of Rochester
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

Recruitment information / eligibility

• 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

Related Conditions & MeSH terms

• Delusions
• Hallucinations
• Parkinson Disease
• Parkinson Disease Psychosis

Intervention

Other:
• Observation of minor phenomena
observation twice a year over 3 years

Locations

Country	Name	City	State
United States	University of Rochester Medical Center	Rochester	New York

Sponsors (2)

Lead Sponsor	Collaborator
University of Rochester	ACADIA Pharmaceuticals Inc.

Country where clinical trial is conducted

United States, 

Outcome

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