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

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.

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Key information

Conditions

Parkinson Disease Basal Ganglia Diseases Behavior Behavioral Symptoms Brain Diseases Central Nervous System Diseases Delusion Delusions Hallucinations Movement Disorders Nervous System Diseases Neurobehavioral Manifestations Neurodegenerative Diseases Neurologic Manifestations Parkinson Disease Psychosis Parkinsonian Disorders Pathological Conditions, Signs and Symptoms Perceptual Disorders Signs and Symptoms Synucleinopathies

Age range

30 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

University of Rochester Medical Center

Rochester, New York, 14642, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Observation of minor phenomena

Other

observation twice a year over 3 years

Primary outcomes

Cumulative probability of developing hallucinations or delusions over time

Time frame: baseline to 36 months

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.

Sponsors and collaborators

Lead sponsor

University of Rochester

Other

Collaborators

ACADIA Pharmaceuticals Inc.

Registry information

Official study title

Characterization and Progression of Minor Phenomena in Parkinson's Disease

Important dates

Study start: 2019
Primary completion: 2023
Study completion: 2023
First posted: Feb 15, 2022
Registry last updated: Mar 8, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed