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

Depression Clinical Trial

— PRODE  

Official title:

Prognosis of Depression in the Elderly (PRODE)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01952366
• Other study ID #: PRODE-2013
• Status: Completed
• Start date: December 2009
• Est. completion date: April 2016

Study information

• Verified date: June 2018
• Source: Sykehuset Innlandet HF
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 169
• Est. completion date: April 2016
• Est. primary completion date: January 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 60 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Dementia
• Depression
• Depressive Disorder

Locations

Country	Name	City	State
Norway	Innlandet Hospital Trust	Ottestad

Sponsors (5)

Lead Sponsor	Collaborator
Sykehuset Innlandet HF	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

Country where clinical trial is conducted

Norway, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)
Primary	Depression	Relapse/recurrence of depression	1 year after inclusion to the study
Secondary	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