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

Completed

• Conditions: Hallucinations; Delusion; Parkinson Disease; Parkinson Disease Psychosis
• Interventions: Other: Observation of minor phenomena

• Registration Number: NCT05240339
• Lead Sponsor: University of Rochester

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2019-04-25
• Study First Submitted: 2022-02-04
• Study First Submitted QC: 2022-02-04
• Study First Posted: 2022-02-15
• Primary Completion: 2023-12-31
• Study Completion: 2023-12-31
• Status Verified: 2024-03
• Last Update Submitted: 2024-03-06
• Last Update Posted: 2024-03-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 38

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
PD participants with minor phenomena	Observation of minor phenomena	-

Primary Outcome Measures

Name	Time	Method
Cumulative probability of developing hallucinations or delusions over time	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.

Trial Locations

Locations (1)

University of Rochester Medical Center; 🇺🇸 Rochester, New York, United States