NCT01817244

Brief Summary

Suicide is a significant cause of death in Korea. According to the report compiled by the Korea National Statistical Office, 24.8 victims of every 100,000 in 2007 (Korea National Statistical Office, 2008), which is higher compared with 10.1 in the United States, 6.0 in the United Kingdom, and 19.1 in Japan (Organisation for Economic Co-operation and Development, 2008). Especially, suicide rate is incredibly higher in elderly. Most persons who commit suicide have a diagnosed psychiatric disorder. Among them, 60% had Depression when they committed suicide. Therefore, this study aimed the impact of a care management intervention on depression treatment and reducing suicidal ideation in elderly patients with depression.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
82

participants targeted

Target at P25-P50 for not_applicable depression

Timeline
Completed

Started Mar 2013

Longer than P75 for not_applicable depression

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

March 1, 2013

Completed
12 days until next milestone

First Submitted

Initial submission to the registry

March 13, 2013

Completed
12 days until next milestone

First Posted

Study publicly available on registry

March 25, 2013

Completed
3.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2016

Completed
Last Updated

January 20, 2017

Status Verified

January 1, 2017

Enrollment Period

3.8 years

First QC Date

March 13, 2013

Last Update Submit

January 18, 2017

Conditions

Depression

Keywords

care managementdepressionelderlyKorea

Outcome Measures

Primary Outcomes (1)

  • Hamilton Depression Scale (HAMD)

    6 months after baseline

Secondary Outcomes (2)

  • suicide ideation

    6 months after baseline

  • treatment compliance

    at 6 months from baseline

Study Arms (2)

care management type 1

EXPERIMENTAL

2-month care management

Other: care management

care management type 2

ACTIVE COMPARATOR

6-month care management

Other: care management

Interventions

care managementOTHER

6-month care management

care management type 1care management type 2

Eligibility Criteria

Age60 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • and older
  • current major or minor depression

You may not qualify if:

  • severe cognitive dysfunction
  • severe auditory dysfunction
  • history of psychosis

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kunkuk University of Chungju Hospital

Chungju, Choong-Book, 380700, South Korea

Location

MeSH Terms

Conditions

Depression

Condition Hierarchy (Ancestors)

Behavioral SymptomsBehavior

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

March 13, 2013

First Posted

March 25, 2013

Study Start

March 1, 2013

Primary Completion

December 1, 2016

Study Completion

December 1, 2016

Last Updated

January 20, 2017

Record last verified: 2017-01

Locations

KR(1)