Clinical trial NCT01952366: Prognosis of Depression in the Elderly (PRODE). A Multicentre, Longitudinal Study of Elderly Depressed Patients.
Official title: Prognosis of Depression in the Elderly (PRODE)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Depression
Dementia
Keywords: Aged
Depression
Cognition
Longitudinal study
Lead sponsor: Sykehuset Innlandet HF
Sponsor class: OTHER
Collaborators: name: South-Eastern Norway Regional Health Authority
name: Norwegian Centre for Ageing and Health
name: Leagacy of Josef and Haldis Andresen
name: Solveig and Johan P's Foundation for Psychiatric Research
First posted: 2013-09-27
Enrollment: 169
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Elderly (\>60 years) depressed patients referred to treatment at specialist helth care service in Norway.

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

Eligibility criteria: 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

Primary outcomes:
measure: Depression
timeFrame: Patients were follow during their stay in the hospital; average days of stay in hospital = 68.3 (SD=46.8)
measure: Depression
timeFrame: 1 year after inclusion to the study
Secondary outcomes:
measure: Number of Patients With a Diagnosis of Dementia
timeFrame: 1 year after inclusion to the study
Other outcomes:
Locations:
city: Ottestad
country: Norway
facility: Innlandet Hospital Trust
Study officials:
affiliation: Norwegian Centre for Ageing and Health
name: Geir Selbaek, MD/Ph.D
role: STUDY_DIRECTOR
affiliation: Innlandet Hospital Trust (Sykehuset Innlandet HF)
name: Tom Borza, MD/PhD cand
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.