DepressionPRODENCT01952366
Prognosis of Depression in the Elderly (PRODE). A Multicentre, Longitudinal Study of Elderly Depressed Patients.
An observational study of Depression and Dementia, run by Sykehuset Innlandet HF at 1 site in Norway.
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. Read more about this study
- Who is it for?
- Ages 60 years and olderHealthy volunteers can take part
- Conditions the study is for
- Depression, Dementia
- How many people
- 169 participants
- Where
- 1 siteNorway
- Study dates
- Dec 2009to Apr 2016
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Elderly (>60 years) depressed patients referred to treatment at specialist helth care service in Norway.
Who may be able to join
- Patients with depression referred to treatment at specialist health care in Norway.
- Patients above 60 years
Who cannot join
- Demented patients with severe aphasia and patients with life threatening diseases will be excluded
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Prognosis of Depression in the Elderly (PRODE)
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.
Read the 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
- Conditions
- Depression, Dementia
- Keywords
- Aged, Depression, Cognition, Longitudinal study
- Medical subject headings
- Depression, Dementia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Depressed patients | Patients admitted to specialist health care service of old age psychiatry |
What is being measured
The primary outcome is the main question the study is designed to answer.
Depression
Relapse/recurrence of depression
Measured: 1 year after inclusion to the study
Depression During Three Years
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.
Measured: Three years follow-up (mean follow-up time: 1167 days (SD=41)
Secondary outcomes (2)
Number of Patients With a Diagnosis of Dementia (According to ICD-10) One 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.
Measured: 1 year after inclusion to the study
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 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.
Measured: 3 years after inclusion to the study (mean time 1167 days, SD 41).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Sep 2013 (estimated)
- Study startDec 2009
- Primary completionJan 2013
- Study completionApr 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for DepressionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 169 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sykehuset Innlandet HF
- Sponsor type
- University, hospital or other
- Collaborators
- 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
- Responsible party
- Sponsor
- Investigators
- Geir Selbaek, MD/Ph.D, Study director, Norwegian Centre for Ageing and HealthTom Borza, MD/PhD cand, Principal investigator, Innlandet Hospital Trust (Sykehuset Innlandet HF)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01952366
- Sponsor's protocol ID
- PRODE-2013
- Acronym
- PRODE
- Status last verified
- Mar 2026
- First submitted
- 24 Sep 2013
- Last updated
- 13 Apr 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Bocharova M, Borza T, Watne LO, Engedal K, O'Brien JT, Selbaek G, Idland AV, Hodsoll J, Young AH, Aarsland D. The role of plasma inflammatory markers in late-life depression and conversion to dementia: a 3-year follow-up study. Mol Psychiatry. 2025 Jul;30(7):3029-3038. doi: 10.1038/s41380-025-02908-2. Epub 2025 Feb 8.
PubMed 39922907Borza T, Engedal K, Bergh S, Selbaek G. Older people with depression - a three-year follow-up. Tidsskr Nor Laegeforen. 2019 Nov 4;139(16). doi: 10.4045/tidsskr.18.0968. Print 2019 Nov 5. English, Norwegian.
PubMed 31686490Borza T, Engedal K, Bergh S, Benth JS, Selbaek G. Trajectories of Depression in Late Life: A 1-Year Follow-Up Study. Dement Geriatr Cogn Disord. 2017;43(3-4):180-192. doi: 10.1159/000458148. Epub 2017 Feb 22.
PubMed 28222439Borza 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.
PubMed 26242794
Study at a glance
From the registry record, last updated by the sponsor on 13 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prognosis of Depression in the Elderly (PRODE)
- ClinicalTrials.gov ID
- NCT01952366
- Acronym / sponsor ID
- PRODE / PRODE-2013
- Conditions
- Depression, Dementia
- Keywords
- Aged, Depression, Cognition, Longitudinal study
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 169 participants (actual)
- Lead sponsor
- Sykehuset Innlandet HFUniversity, hospital or other
- Collaborators
- 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 start
- Dec 2009
- Primary completion
- Jan 2013 (actual)
- Study completion
- Apr 2016 (actual)
- First posted
- 27 Sep 2013 (estimated)
- Results
- Posted 22 Sep 2016
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Depressed patients | – | –Patients admitted to specialist health care service of old age psychiatry |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Elderly (>60 years) depressed patients referred to treatment at specialist helth care service in Norway.
Key inclusion criteria (2 listed)
- Patients with depression referred to treatment at specialist health care in Norway.
- Patients above 60 years
Key exclusion criteria (1 listed)
- Demented patients with severe aphasia and patients with life threatening diseases will be excluded
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Depression
Time frame: 1 year after inclusion to the study
Relapse/recurrence of depression
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.
2 secondary outcomes
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
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).
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Apr 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 39922907Bocharova M, Borza T, Watne LO, Engedal K, O'Brien JT, Selbaek G, Idland AV, Hodsoll J, Young AH, Aarsland D. The role of plasma inflammatory markers in late-life depression and conversion to dementia: a 3-year follow-up study. Mol Psychiatry. 2025 Jul;30(7):3029-3038. doi: 10.1038/s41380-025-02908-2. Epub 2025 Feb 8.
- Results publication: PubMed 31686490Borza T, Engedal K, Bergh S, Selbaek G. Older people with depression - a three-year follow-up. Tidsskr Nor Laegeforen. 2019 Nov 4;139(16). doi: 10.4045/tidsskr.18.0968. Print 2019 Nov 5. English, Norwegian.
- Results publication: PubMed 28222439Borza T, Engedal K, Bergh S, Benth JS, Selbaek G. Trajectories of Depression in Late Life: A 1-Year Follow-Up Study. Dement Geriatr Cogn Disord. 2017;43(3-4):180-192. doi: 10.1159/000458148. Epub 2017 Feb 22.
- Derived from this study: PubMed 26242794Borza 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Geir Selbaek, MD/Ph.D study director
Norwegian Centre for Ageing and Health
Tom Borza, MD/PhD cand principal investigator
Innlandet Hospital Trust (Sykehuset Innlandet HF)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Depression and Dementia, run by Sykehuset Innlandet HF at 1 site in Norway.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Norway. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 22 Sep 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Depression (time frame: 1 year after inclusion to the study). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01952366, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Apr 2026.