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NCT Number: NCT01952366

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

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.

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Key information

Conditions

Depression Behavior Behavioral Symptoms Brain Diseases Central Nervous System Diseases Dementia Mental Disorders Nervous System Diseases Neurocognitive Disorders

Age range

60 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Innlandet Hospital Trust

Ottestad, 2315, Norway

About this study

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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Depression

    Time frame: 1 year after inclusion to the study

    Relapse/recurrence of depression

  2. 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.

Secondary outcomes

  1. 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.

  2. 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.

Sponsors and collaborators

Lead sponsor

Sykehuset Innlandet HF

Other

Collaborators

  • Leagacy of Josef and Haldis Andresen
  • Norwegian Centre for Ageing and Health
  • Solveig and Johan P's Foundation for Psychiatric Research
  • South-Eastern Norway Regional Health Authority

Registry information

Official study title

Prognosis of Depression in the Elderly (PRODE)

Acronym: PRODE

Important dates

Study start
2009
Primary completion
2013
Study completion
2016
First posted
Sep 27, 2013
Registry last updated
Apr 13, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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