Ignite Creation Date:
2025-12-24 @ 4:14 PM
Ignite Modification Date:
2025-12-29 @ 12:44 PM
Study NCT ID:
NCT01952366
Status:
COMPLETED
Last Update Posted:
2023-11-27
First Post:
2013-09-24
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Prognosis of Depression in the Elderly (PRODE). A Multicentre, Longitudinal Study of Elderly Depressed Patients.
Sponsor:
Sykehuset Innlandet HF
Organization:
Study Overview
Official Title:
Prognosis of Depression in the Elderly (PRODE)
Status:
COMPLETED
Status Verified Date:
2018-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
PRODE
Brief Summary:
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.
The study hypothesis is that elderly patients referred to specialist health service have a poor long term prognosis.
Detailed 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 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
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 Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: