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

Prognosis of Depression in the Elderly (PRODE)

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.

Study Overview

• Status: Completed
• Conditions: Depression; Dementia

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

• Study Type: Observational
• Enrollment (Actual): 169

Contacts and Locations

Study Locations

• Norway
  • Ottestad, Norway, 2315
    • Innlandet Hospital Trust

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 60 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

Study Population

Elderly (>60 years) depressed patients referred to treatment at specialist helth care service in Norway.

Description

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 Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
Depressed patients; Patients admitted to specialist health care service of old age psychiatry

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Sykehuset Innlandet HF
• Collaborators: Norwegian Centre for Ageing and Health; South-Eastern Norway Regional Health Authority; Leagacy of Josef and Haldis Andresen; Solveig and Johan P's Foundation for Psychiatric Research
• Investigators: 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)

Publications and helpful links

General Publications

• Borza T, Engedal K, Bergh S, Benth JS, Selbaek G. The course of depression in late life as measured by the Montgomery and Asberg Depression Rating Scale in an observational study of hospitalized patients. BMC Psychiatry. 2015 Aug 5;15:191. doi: 10.1186/s12888-015-0577-8.

Study record dates

Study Major Dates

• Study Start: December 1, 2009
• Primary Completion (Actual): January 1, 2013
• Study Completion (Actual): April 1, 2016

Study Registration Dates

• First Submitted: September 24, 2013
• First Submitted That Met QC Criteria: September 26, 2013
• First Posted (Estimated): September 27, 2013

Study Record Updates

• Last Update Posted (Actual): November 27, 2023
• Last Update Submitted That Met QC Criteria: November 22, 2023
• Last Verified: June 1, 2018

More Information

Terms related to this study

• Keywords: Depression; Cognition; Aged; Longitudinal study
• Additional Relevant MeSH Terms: Behavioral Symptoms; Mental Disorders; Mood Disorders; Depression; Depressive Disorder
• Other Study ID Numbers: PRODE-2013