NCT03105401

Brief Summary

This study aims to describe hallucinations prevalence in a sample of patients affected by Parkinson's disease and consulting in an outpatient facility. An unique one hour interview will be offered to volunteers patients. Patients participating to the study will be asked to answer a semi-structured questionnaire searching for hallucinations of all modalities, minor psychotic symptoms and delusions. Psychometric scales will be assessed to search for depressive symptoms, cognitive impairment and specific personality characteristics. The study hypothesis is that hallucinations prevalence in Parkinson's disease is underestimated and is higher than usually described in the scientific literature when all hallucinations modalities and minor hallucinatory phenomenons are searched for.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
32

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started May 2017

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 4, 2017

Completed
6 days until next milestone

First Posted

Study publicly available on registry

April 10, 2017

Completed
1 month until next milestone

Study Start

First participant enrolled

May 15, 2017

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 25, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 25, 2018

Completed
Last Updated

January 17, 2019

Status Verified

January 1, 2019

Enrollment Period

12 months

First QC Date

April 4, 2017

Last Update Submit

January 15, 2019

Conditions

Outcome Measures

Primary Outcomes (1)

  • Hallucinations Prevalence

    Semi-structured questionnaire precisely describing hallucinations of all modalities and their characteristics, as well as minor hallucinations and delusions. Binary Yes/No possible answers. Unique 1 hour interview to assess semi-structured questionnaire for primary outcome measurement, and psychometric scales.

    1 hour

Study Arms (1)

Patients affected by Parkinson's disease

Outpatients affected by Parkinson's Disease consulting in neurology can be included if volunteer

Other: Assessment of hallucinations in Parkinson's disease

Interventions

Patients participating to the study will be asked to answer a semi-structured questionnaire searching for hallucinations of all modalities, minor psychotic symptoms and delusions. Psychometric scales will be assessed to search for depressive symptoms, cognitive impairment and specific personality characteristics.

Patients affected by Parkinson's disease

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Outpatients affected by Parkinson's Disease consulting in neurology can be included if volunteer

You may qualify if:

  • Age ≥ 18 years-old
  • Absence of opposition from the patient himself/herself or his/her legal representant for his/her participation to the study
  • Patient without superior age limit with a diagnosis of Parkinson's disease made according to the UKPDSBB criteria (UK Parkinson's Disease Society Brain Bank clinical diagnostic criteria)
  • Outpatient consulting in neurology at the Charpennes'hospital

You may not qualify if:

  • Opposition to the study
  • Deafness or blindness which could compromise the interview

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hôpital des Charpennes. Centre de Recherche Clinique - vieillissement, cerveau, fragilité

Villeurbanne, 69100, France

Location

MeSH Terms

Conditions

Parkinson Disease

Condition Hierarchy (Ancestors)

Parkinsonian DisordersBasal Ganglia DiseasesBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesMovement DisordersSynucleinopathiesNeurodegenerative Diseases

Study Officials

  • Jing XIE, MD

    Hôpital des Charpennes. Centre de Recherche Clinique - vieillissement, cerveau, fragilité

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 4, 2017

First Posted

April 10, 2017

Study Start

May 15, 2017

Primary Completion

April 25, 2018

Study Completion

April 25, 2018

Last Updated

January 17, 2019

Record last verified: 2019-01

Locations