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

March 25, 2026 updated by: Sykehuset Innlandet HF

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

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

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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
Time Frame: 1 year after inclusion to the study
Relapse/recurrence of depression
1 year after inclusion to the study
Depression During Three Years
Time Frame: Three years follow-up (mean follow-up time: 1167 days (SD=41)
We have described the course of depression after treatment in departments of old-age psychiatry at specialist healthcare services using assessments at one- and year follow-up. The patients were decribed in the following categories courses: Favourable/less favourable/unfavourable/unclassifiable.
Three years follow-up (mean follow-up time: 1167 days (SD=41)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Patients With a Diagnosis of Dementia (According to ICD-10) One Year After Inclusion to the Study.
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.
1 year after inclusion to the study
Number of Patients With a Diagnosis of Dementia (According to ICD-10) Three Years After Inclusion to the Study.
Time Frame: 3 years after inclusion to the study (mean time 1167 days, SD 41).
3 years after inclusion to the study there was an assessment inluding all available information on cognition; i.e. information from previous follow-ups, clinical or telephone assessment of cognition using Mini Mental Status Examination (MMSE, clinical or telephone-version), and information from next-of-kin or caregivers including the Informant Questionnaire on Cognitive Decline in the Elderly (IQCODE) and The Clinical Dementia Rating (CDR). Three Senior Consultants with a PhD then used all available information to diagnose dementia according to the ICD-10 classification.
3 years after inclusion to the study (mean time 1167 days, SD 41).

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

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

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

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)

April 13, 2026

Last Update Submitted That Met QC Criteria

March 25, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PRODE-2013

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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