Validation of the French Version of the Geriatric Mental State (GMS) (GMS-Package)
Recruitment status was Recruiting
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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 |
|---|
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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 |
- 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.
- 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.
| Estimated Enrollment: | 120 |
| Study Start Date: | June 2008 |
| 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 |
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.
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| Contact: Vincent CAMUS, PHD-Pr | +33(0)247479130 | camus@med.univ-tours.fr |
| Contact: Valerie GISSOT, PHD | 0-+33(0) 234379653 | valerie.gissot@univ-tours.fr |
| France | |
| CHU-Limoges- CMRR | Recruiting |
| Limoges, Limouzin, France, F-87025 | |
| Contact: Philippe NUBUKPO, MD-PHD +33555435820 philippe.nubukpo@9online.fr | |
| Contact: Pierre-Marie PREUX, MD-PHD 33 (0)5 55 43 58 20 preux@unilim.fr | |
| Sub-Investigator: Pierre-Marie PREUX, MD-PHD | |
| Principal Investigator: Philippe NUBUKPO, MD-PHD | |
| Sub-Investigator: Philippe COURATIER, MD-PHD | |
| University Hospital | Recruiting |
| Tours, France, 37044 | |
| Contact: Vincent CAMUS, MD-PHD +33(0)247479130 camus@med.univ-tours.fr | |
| Contact: Valerie GISSOT, MD +33(0)234379653 valerie.gissot@univ-tours.fr | |
| Principal Investigator: Vincent CAMUS, MD-PHD | |
| Sub-Investigator: Caroline HOMMET, MD-PHD | |
| Sub-Investigator: Valerie GISSOT, MD | |
| Sub-Investigator: Natacha PERU, MD | |
| Sub-Investigator: Luc ZAWADSKI, MD | |
| Study Director: | Vincent CAMUS, MD-PHD | CHRU-Tours |
| Principal Investigator: | Philippe NUBUKPO, MD-PHD | CHU-Limoges |
More Information
No publications provided
| Responsible Party: | CAMUS Vincent , MD, 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: | May 2, 2011 |
| 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 May 16, 2013