This trial is active, not recruiting.

Conditions depression, dementia
Sponsor Sykehuset Innlandet HF
Collaborator South-Eastern Norway Regional Health Authority
Start date December 2009
End date January 2013
Trial size 338 participants
Trial identifier NCT01952366, PRODE-2013


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.

United States No locations recruiting
Other countries No locations recruiting

Study Design

Observational model cohort
Time perspective prospective
Non depressed controls

Primary Outcomes

time frame: Recerrence of depression and MADRS, Cornell one year after inclusion to the study

Secondary Outcomes

time frame: Cognition as measured with MMSE and clinical diagnosis one year after inclusion to the study

Eligibility Criteria

Male or female participants at least 60 years old.

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

Additional Information

Official title Prognosis of Depression in the Elderly (PRODE)
Principal investigator Tom Borza, MD/PhD cand
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 Montgomary and Aasbergs Depression Rating Scale (MADRS), Cornell Scale for Depression in Dementia (CSDD) and Hospital Anxiety and Depression Scale (HADS) - 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
Trial information was received from ClinicalTrials.gov and was last updated in November 2014.
Information provided to ClinicalTrials.gov by Sykehuset Innlandet HF.