Prognosis of Depression in the Elderly (PRODE). A Multicentre, Longitudinal Study of Elderly Depressed Patients.

Study Overview
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Brief Summary
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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.

Detailed Description
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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 Montgomery and Asberg Depression Rating Scale (MADRS), Cornell Scale for Depression in Dementia (CSDD) and Hospital Anxiety and Depression Scale (HADS), trajectories and clinical assessments. 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

Official Title
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Prognosis of Depression in the Elderly (PRODE)

Conditions
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Depression, Dementia

Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Depressed patients<br>Patients admitted to specialist health care service of old age psychiatry | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Depression | Response (50% improvement on the Montgomery and Asberg Depression Rating Scale (MADRS) score) Remission (defined as score of 9 or less on the MADRS) The MADRS is a measurement of the severity of depression and consists of 10 items rated from 0 points (no symptoms) to 6 (severe symptoms) | Patients were follow during their stay in the hospital; average days of stay in hospital = 68.3 (SD=46.8) | 
| Depression | Relapse/recurrence of depression | 1 year after inclusion to the study | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Patients With a Diagnosis of Dementia | One year after inclusion to the study, there will be a clinical assessment of the patient including a MMSE, if possible, and to evaluate if the patients have dementia. | 1 year after inclusion to the study | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Aged, Depression, Cognition, Longitudinal study