Dementia, Depression
Conditions
Keywords
Aged, Depression, Cognition, Longitudinal study
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
Interventions
None listed
Sponsors
Sykehuset Innlandet HF
South-Eastern Norway Regional Health Authority
Norwegian Centre for Ageing and Health
Leagacy of Josef and Haldis Andresen
Solveig and Johan P's Foundation for Psychiatric Research
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
60 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Depression | 1 year after inclusion to the study | Relapse/recurrence of depression |
| Depression During Three Years | 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
| Measure | Time frame | Description |
|---|---|---|
| Number of Patients With a Diagnosis of Dementia (According to ICD-10) One Year After Inclusion to the Study. | 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. |
| Number of Patients With a Diagnosis of Dementia (According to ICD-10) Three Years After Inclusion to the Study. | 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. |
Countries
Norway
Contacts
STUDY_DIRECTORGeir Selbaek, MD/Ph.D
Norwegian Centre for Ageing and Health
PRINCIPAL_INVESTIGATORTom Borza, MD/PhD cand
Innlandet Hospital Trust (Sykehuset Innlandet HF)
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Depressed Patients Patients admitted to specialist health care service of old age psychiatry | 169 |
| Total | 169 |
Baseline characteristics
| Characteristic | Depressed Patients |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 163 Participants |
| Age, Categorical Between 18 and 65 years | 6 Participants |
| Age, Continuous | 76.1 years STANDARD_DEVIATION 6.8 |
| Region of Enrollment Norway | 169 participants |
| Sex: Female, Male Female | 123 Participants |
| Sex: Female, Male Male | 46 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| other Total, other adverse events | 0 / 169 |
| serious Total, serious adverse events | 0 / 169 |
Outcome results
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)
Time frame: Patients were follow during their stay in the hospital; average days of stay in hospital = 68.3 (SD=46.8)
Population: Patients with complete MADRS records
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Response in Depressed Patients | Depression | 99 participants |
| Remission in Depressed Patients | Depression | 74 participants |
Primary
Depression
Relapse/recurrence of depression
Time frame: 1 year after inclusion to the study
Population: Inpatients
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Response in Depressed Patients | Depression | 48 participants |
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.
Time frame: 1 year after inclusion to the study
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Response in Depressed Patients | Number of Patients With a Diagnosis of Dementia | 23 Participants |