Trial Outcomes & Findings for Prognosis of Depression in the Elderly (PRODE). A Multicentre, Longitudinal Study of Elderly Depressed Patients. (NCT NCT01952366)

Results Overview

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)

Recruitment status

COMPLETED

Target enrollment

169 participants

Primary outcome timeframe

Patients were follow during their stay in the hospital; average days of stay in hospital = 68.3 (SD=46.8)

Results posted on

2023-11-27

Participant Flow

Participant milestones

Participant milestones
Measure	Depressed Patients Patients admitted to specialist health care service of old age psychiatry
Overall Study STARTED	169
Overall Study COMPLETED	138
Overall Study NOT COMPLETED	31

Reasons for withdrawal

Reasons for withdrawal
Measure	Depressed Patients Patients admitted to specialist health care service of old age psychiatry
Overall Study Death	22
Overall Study Withdrawal by Subject	9

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Depressed Patients n=169 Participants Patients admitted to specialist health care service of old age psychiatry
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	6 Participants n=5 Participants
Age, Categorical >=65 years	163 Participants n=5 Participants
Age, Continuous	76.1 years STANDARD_DEVIATION 6.8 • n=5 Participants
Sex: Female, Male Female	123 Participants n=5 Participants
Sex: Female, Male Male	46 Participants n=5 Participants
Region of Enrollment Norway	169 participants n=5 Participants

PRIMARY outcome

Timeframe: 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

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)

Outcome measures

Outcome measures
Measure	Response in Depressed Patients n=145 Participants Number of patients admitted to specialist health care service of old age psychiatry who demonstrated a response (50% improvement of the MADRS score) during stay in the hospital.	Remission in Depressed Patients n=145 Participants Number of patients admitted to specialist health care service of old age psychiatry who demonstrated a remission (MADRS score of 9 or less) by the end of their hospital stay.
Depression	99 participants	74 participants

PRIMARY outcome

Timeframe: 1 year after inclusion to the study

Population: Inpatients

Relapse/recurrence of depression

Outcome measures

Outcome measures
Measure	Response in Depressed Patients n=146 Participants Number of patients admitted to specialist health care service of old age psychiatry who demonstrated a response (50% improvement of the MADRS score) during stay in the hospital.	Remission in Depressed Patients Number of patients admitted to specialist health care service of old age psychiatry who demonstrated a remission (MADRS score of 9 or less) by the end of their hospital stay.
Depression	48 participants	—

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Response in Depressed Patients n=146 Participants Number of patients admitted to specialist health care service of old age psychiatry who demonstrated a response (50% improvement of the MADRS score) during stay in the hospital.	Remission in Depressed Patients Number of patients admitted to specialist health care service of old age psychiatry who demonstrated a remission (MADRS score of 9 or less) by the end of their hospital stay.
Number of Patients With a Diagnosis of Dementia	23 Participants	—

Adverse Events

Depressed Patients

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Tom Borza

Sykehuset Innlandet

Phone: +47 91834607

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place