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

Completed

Conditions: Depression
Dementia

Registration Number: NCT01952366

Lead Sponsor: Sykehuset Innlandet HF

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.

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

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 169

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

Study & Design

Study Type: OBSERVATIONAL

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Depression	1 year after inclusion to the study	Relapse/recurrence of depression

Secondary Outcome Measures

Name	Time	Method
Number of Patients With a Diagnosis of Dementia	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.