Prognosis of Depression in the Elderly (PRODE). A Multicentre, Longitudinal Study of Elderly Depressed Patients.
This trial is active, not recruiting.
|Sponsor||Sykehuset Innlandet HF|
|Collaborator||South-Eastern Norway Regional Health Authority|
|Start date||December 2009|
|End date||January 2013|
|Trial size||338 participants|
|Trial identifier||NCT01952366, PRODE-2013|
PRODE is a Norwegian multicentre study investigating the prognosis of depression in the elderly. The study has included 169 patients who will be followed with assessments after one and three years.
The study hypothesis is that elderly patients referred to specialist health service have a poor long term prognosis.
Non depressed controls
time frame: Recerrence of depression and MADRS, Cornell one year after inclusion to the study
time frame: Cognition as measured with MMSE and clinical diagnosis one year after inclusion to the study
Male or female participants at least 60 years old.
Inclusion Criteria: - Patients with depression referred to treatment at specialist health care in Norway. - Patients above 60 years Exclusion Criteria: - Demented patients with severe aphasia and patients with life threatening diseases will be excluded
|Official title||Prognosis of Depression in the Elderly (PRODE)|
|Principal investigator||Tom Borza, MD/PhD cand|
|Description||Objective: Depression in the elderly is difficult to treat and is often of chronic or recurrent nature. There is little knowledge about the course and the risk factors for recurrence of depression among elderly people in Norway. The aim of the PRODE-study is to examine the short- and long-term prognosis of elderly depressed patients who are referred for treatment in departments of old age psychiatry. Method: PRODE is a multicentre case-control and longitudinal study of elderly (>60 years) depressed and non-depressed patients with a one and three year follow-up. Nine participating departments of old age psychiatry used the same standardized instruments to collect data of the patients on depression and other mental health issues, cognition, physical health, medications, functions in activities of daily living, quality of life and family carers' situation. The included patients and controls underwent an MRI scan of the brain according to a comprehensive protocol developed for this project. Furthermore, blood and saliva from the included patients are stored in a Biobank for analyses of pro- and anti-inflammatory cytokines and cortisol. The study included 169 patients (December 2009-January 2013) and will include the same number of non-depressed controls. Outcome Measures (short-term): - Depression as measured with the Montgomary and Aasbergs Depression Rating Scale (MADRS), Cornell Scale for Depression in Dementia (CSDD) and Hospital Anxiety and Depression Scale (HADS) - Function in activities of daily living Outcome measures (long-term): - Cognition as measured by Mini Mental State Examination (MMSE) and diagnosis of dementia. - Depression, recurrence of depression and as measured wtih the MADRS and CSDD. - Use of health care facilities; nursing home. - Mortality - Function in activities of daily living|
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