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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT03105401
Other study ID # 69HCL17_0137
Secondary ID
Status Terminated
Phase
First received
Last updated
Start date May 15, 2017
Est. completion date April 25, 2018

Study information

Verified date January 2019
Source Hospices Civils de Lyon
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


Recruitment information / eligibility

Status Terminated
Enrollment 32
Est. completion date April 25, 2018
Est. primary completion date April 25, 2018
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria:

- 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

Exclusion Criteria:

- Opposition to the study

- Deafness or blindness which could compromise the interview

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Assessment of hallucinations in Parkinson's disease
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.

Locations

Country Name City State
France Hôpital des Charpennes. Centre de Recherche Clinique - vieillissement, cerveau, fragilité Villeurbanne

Sponsors (1)

Lead Sponsor Collaborator
Hospices Civils de Lyon

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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
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