- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01061827
Validation of the French Version of the Geriatric Mental State (GMS) (GMS-Package)
Validation of the French Version of the Geriatric Mental State: a Structured and Standardized Interview for Diagnosis of Psychiatric Disorders in the Elderly
A major public health issues of today's aging population is the development of knowledge and expertise in geriatric medicine and psychiatry of the elderly. The depressive disorders and dementia, are among the psychiatric conditions most common in older age. They are the subject of much clinical research, in which brain imaging techniques used to establish correlations anatomo-clinical and radiological-clinical. The prerequisite for the realization of such work locally, is the validation in their French version of clinical assessment tools most commonly used internationally, ensuring reliability, acceptability and comparability of results. Among these tools, "Geriatric Mental Schedule (GMS) Package", is the reference tool for research in psychiatry of the elderly. It is a standardized and structured questionnaire that allows to establish with reliability and reproducibility on the basis of answers to questions, major psychiatric diagnoses in the elderly. It has been validated in several languages (German, Spanish, Italian, Dutch, but also Chinese, Korean ...), but is still not available in French.
Hypothesis: Validate the the French version of "Geriatric Mental Schedule (GMS) Package", to establish diagnoses of dementia and depressive disorders.
Study Overview
Status
Conditions
Detailed Description
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Tours, France, 37044
- University Hospital
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Limouzin
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Limoges, Limouzin, France, F-87025
- CHU-Limoges- CMRR
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Patients 65 years or more, Nearest available to assist with the interview of informal caregivers For the subjects in the "dementia", meets the ICD-10 criteria for dementia, and CDR score at 1 to 2, with or without treatment For the subjects in the "depression", ICD-10 criteria for major depression, score on the depression scale MADRS of 18 or more, with or without treatment For control subjects, level of education based on the number of years of schooling (compulsory education until 16 years, extended school)
Non-inclusion criteria Subjects with symptoms involving mixed dementia and depression such as not allowing complete ICD-10 criteria for dementia or depression.
Description
Inclusion Criteria:
- Nearest available to assist with the interview of informal caregivers For the subjects in the "dementia", meets the ICD-10 criteria for dementia, and CDR score at 1 to 2, with or without treatment For the subjects in the "depression", ICD-10 criteria for major depression, score on the depression scale MADRS of 18 or more, with or without treatment For control subjects, level of education based on the number of years of schooling (compulsory education until 16 years, extended school)
Exclusion Criteria:
- Subjects with symptoms involving mixed dementia and depression such as not allowing complete ICD-10 criteria for dementia or depression.
Study Plan
How is the study designed?
Design Details
- Observational Models: Case-Only
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
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Control
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Dementia
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Depression
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Diagnostic of dementia and depression
Time Frame: four years
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Validate the French version of the Geriatric Mental State package.The GMS is a standardised, semi-structured interview for examining and recording the mental state in elderly subjects.
It allows the classification of patients by symptom profile and can demonstrate changes in profile over time.
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four years
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Interjudge concordance for discrimination on control,depression and dementia patients
Time Frame: 4 years
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Measure the metrologic qualities, validition,sensibility, specificity against "gold standard" references as MADRS et CDR.
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4 years
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Collaborators and Investigators
Sponsor
Investigators
- Study Director: Vincent CAMUS, MD-PHD, CHRU-TOURS
- Principal Investigator: Philippe NUBUKPO, MD-PHD, CHU-Limoges
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- AOHP/04/VC-GMS
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