NCT01952366

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
169

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Dec 2009

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2009

Completed
3.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2013

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

September 24, 2013

Completed
3 days until next milestone

First Posted

Study publicly available on registry

September 27, 2013

Completed
2.5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2016

Completed
6 months until next milestone

Results Posted

Study results publicly available

September 22, 2016

Completed
Last Updated

April 13, 2026

Status Verified

March 1, 2026

Enrollment Period

3.1 years

First QC Date

September 24, 2013

Results QC Date

April 18, 2016

Last Update Submit

March 25, 2026

Conditions

DepressionDementia

Keywords

AgedDepressionCognitionLongitudinal study

Outcome Measures

Primary Outcomes (2)

  • Depression

    Relapse/recurrence of depression

    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.

    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.

    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 (mean time 1167 days, SD 41).

Study Arms (1)

Depressed patients

Patients admitted to specialist health care service of old age psychiatry

Eligibility Criteria

Age60 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Elderly (\>60 years) depressed patients referred to treatment at specialist helth care service in Norway.

You may qualify if:

  • Patients with depression referred to treatment at specialist health care in Norway.
  • Patients above 60 years

You may not qualify if:

  • \- Demented patients with severe aphasia and patients with life threatening diseases will be excluded

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Innlandet Hospital Trust

Ottestad, 2315, Norway

Location

Related Publications (4)

  • 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.

    PMID: 39922907RESULT

  • Borza 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.

    PMID: 31686490RESULT

  • Borza 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.

    PMID: 28222439RESULT

  • 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.

    PMID: 26242794DERIVED

Biospecimen

Retention: SAMPLES WITH DNA

Apolipoprotein E polymorphism

MeSH Terms

Conditions

DepressionDementia

Condition Hierarchy (Ancestors)

Behavioral SymptomsBehaviorBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesNeurocognitive DisordersMental Disorders

Results Point of Contact

Title
Dr. PhD Tom Borza
Organization
Sykehuset Innlandet
tom.borza@sykehuset-innlandet.no
+47 91834607

Study Officials

  • Geir Selbaek, MD/Ph.D

    Norwegian Centre for Ageing and Health

    STUDY DIRECTOR

  • Tom Borza, MD/PhD cand

    Innlandet Hospital Trust (Sykehuset Innlandet HF)

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 24, 2013

First Posted

September 27, 2013

Study Start

December 1, 2009

Primary Completion

January 1, 2013

Study Completion

April 1, 2016

Last Updated

April 13, 2026

Results First Posted

September 22, 2016

Record last verified: 2026-03

Locations

NO(1)