Prognosis of Depression in the Elderly (PRODE). A Multicentre, Longitudinal Study of Elderly Depressed Patients. (PRODE)
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| ClinicalTrials.gov Identifier: NCT01952366 |
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Recruitment Status :
Completed
First Posted : September 27, 2013
Results First Posted : September 22, 2016
Last Update Posted : July 26, 2018
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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.
| Condition or disease |
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| Depression Dementia |
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
| Study Type : | Observational |
| Actual Enrollment : | 169 participants |
| Observational Model: | Cohort |
| Time Perspective: | Prospective |
| Official Title: | Prognosis of Depression in the Elderly (PRODE) |
| Study Start Date : | December 2009 |
| Actual Primary Completion Date : | January 2013 |
| Actual Study Completion Date : | April 2016 |
| Group/Cohort |
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Depressed patients
Patients admitted to specialist health care service of old age psychiatry
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- Depression [ Time Frame: Patients were follow during their stay in the hospital; average days of stay in hospital = 68.3 (SD=46.8) ]
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)
- Depression [ Time Frame: 1 year after inclusion to the study ]Relapse/recurrence of depression
- Number of Patients With a Diagnosis of Dementia [ Time Frame: 1 year after inclusion to the study ]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.
Biospecimen Retention: Samples With DNA
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| Ages Eligible for Study: | 60 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | Yes |
| Sampling Method: | Non-Probability Sample |
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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01952366
| Norway | |
| Innlandet Hospital Trust | |
| Ottestad, Norway, 2315 | |
| Study Director: | Geir Selbaek, MD/Ph.D | Norwegian Centre for Ageing and Health | |
| Principal Investigator: | Tom Borza, MD/PhD cand | Innlandet Hospital Trust (Sykehuset Innlandet HF) |
| Responsible Party: | Sykehuset Innlandet HF |
| ClinicalTrials.gov Identifier: | NCT01952366 |
| Other Study ID Numbers: |
PRODE-2013 |
| First Posted: | September 27, 2013 Key Record Dates |
| Results First Posted: | September 22, 2016 |
| Last Update Posted: | July 26, 2018 |
| Last Verified: | June 2018 |
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Aged Depression Cognition Longitudinal study |
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Depression Depressive Disorder Behavioral Symptoms Mood Disorders Mental Disorders |