Validation of the French Version of the Geriatric Mental State (GMS) (GMS-Package)

This study has been completed.
Sponsor:
Collaborator:
Institut National de la Santé Et de la Recherche Médicale, France
Information provided by (Responsible Party):
University Hospital, Tours
ClinicalTrials.gov Identifier:
NCT01061827
First received: February 2, 2010
Last updated: December 18, 2013
Last verified: August 2013
  Purpose

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.


Condition
Validate the French Version of "GMS Package" for the Diagnosis of Dementia and Depression.

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Validation of the French Version of the Geriatric Mental State: a Structured and Standardized Interview for Diagnosis of Psychiatric Disorders in the Elderly

Resource links provided by NLM:


Further study details as provided by University Hospital, Tours:

Primary Outcome Measures:
  • Diagnostic of dementia and depression [ Time Frame: four years ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • Interjudge concordance for discrimination on control,depression and dementia patients [ Time Frame: 4 years ] [ Designated as safety issue: No ]
    Measure the metrologic qualities, validition,sensibility, specificity against "gold standard" references as MADRS et CDR.


Enrollment: 96
Study Start Date: June 2008
Study Completion Date: November 2013
Primary Completion Date: June 2008 (Final data collection date for primary outcome measure)
Groups/Cohorts
Dementia
Depression
Control

Detailed Description:

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) Affiliation with a social security scheme Consent signed by the subject and the near Non-inclusion criteria Subjects with symptoms involving mixed dementia and depression such as not allowing complete ICD-10 criteria for dementia or depression.

  Eligibility

Ages Eligible for Study:   65 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
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.

Criteria

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.
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01061827

Locations
France
CHU-Limoges- CMRR
Limoges, Limouzin, France, F-87025
University Hospital
Tours, France, 37044
Sponsors and Collaborators
University Hospital, Tours
Institut National de la Santé Et de la Recherche Médicale, France
Investigators
Study Director: Vincent CAMUS, MD-PHD CHRU-Tours
Principal Investigator: Philippe NUBUKPO, MD-PHD CHU-Limoges
  More Information

No publications provided

Responsible Party: University Hospital, Tours
ClinicalTrials.gov Identifier: NCT01061827     History of Changes
Other Study ID Numbers: AOHP/04/VC-GMS
Study First Received: February 2, 2010
Last Updated: December 18, 2013
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Keywords provided by University Hospital, Tours:
GMS-package;dementia;depression

Additional relevant MeSH terms:
Dementia
Depression
Depressive Disorder
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Delirium, Dementia, Amnestic, Cognitive Disorders
Mental Disorders
Behavioral Symptoms
Mood Disorders

ClinicalTrials.gov processed this record on July 20, 2014