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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00279682
Other study ID # R01MH059366
Secondary ID R01MH059380R01MH
Status Completed
Phase Phase 4
First received January 17, 2006
Last updated January 17, 2006
Start date May 1999
Est. completion date August 2003

Study information

Verified date January 2006
Source Weill Medical College of Cornell University
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug Administration
Study type Interventional

Clinical Trial Summary

The purpose of this study was to determine the effect of a primary care intervention on reducing suicidal ideation and depression in older patients.


Description:

Suicide rates are highest in late life; the majority of older adults who die by suicide have seen a primary care physician in preceding months. Depression is the strongest risk factor for late-life suicide and for suicide’s precursor, suicidal ideation.

The aim of the study was to determine the extent to which an intervention taht combined treatment guidelines with care management reduced rates of depression and suicide ideation in older primary care patients. The study randomized 20 primary care practices from New York City, Philadelphia, and Pittsburgh regions into intervention or usual car. The used a two-stage sampling design that resulted in a representative sample with an oversample of depressed patients (total n=1238 subjects including 598 with a depression diagnosis and 640 with no depression diagnosis). Patients were assessed at baseline, 4, 8, 12, 18 and 24 months.


Recruitment information / eligibility

Status Completed
Enrollment 1200
Est. completion date August 2003
Est. primary completion date
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 60 Years and older
Eligibility Inclusion Criteria:

upcoming appointment with primary care clinician

Exclusion Criteria:

- inability to give consent

- minimental status examination <18

- ability to communicate in English

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention


Related Conditions & MeSH terms


Intervention

Behavioral:
treatment guidelines and depression care management


Locations

Country Name City State
United States Universilty of Pennsylvania Philadelphia Pennsylvania
United States University of Pittsburgh Pittsburgh Pennsylvania
United States Weill Medical College of Cornell University White Plains New York

Sponsors (6)

Lead Sponsor Collaborator
Weill Medical College of Cornell University Forest Laboratories, National Institute of Mental Health (NIMH), The John A. Hartford Foundation, University of Pennsylvania, University of Pittsburgh

Country where clinical trial is conducted

United States, 

References & Publications (4)

Alexopoulos GS, Katz IR, Bruce ML, Heo M, Ten Have T, Raue P, Bogner HR, Schulberg HC, Mulsant BH, Reynolds CF 3rd; PROSPECT Group. Remission in depressed geriatric primary care patients: a report from the PROSPECT study. Am J Psychiatry. 2005 Apr;162(4): — View Citation

Bruce ML, Pearson JL. Designing an intervention to prevent suicide: PROSPECT (Prevention of Suicide in Primary Care Elderly: Collaborative Trial). Dialogues Clin Neurosci. 1999 Sep;1(2):100-12. — View Citation

Bruce ML, Ten Have TR, Reynolds CF 3rd, Katz II, Schulberg HC, Mulsant BH, Brown GK, McAvay GJ, Pearson JL, Alexopoulos GS. Reducing suicidal ideation and depressive symptoms in depressed older primary care patients: a randomized controlled trial. JAMA. 2 — View Citation

Gallo JJ, Bogner HR, Morales KH, Post EP, Ten Have T, Bruce ML. Depression, cardiovascular disease, diabetes, and two-year mortality among older, primary-care patients. Am J Geriatr Psychiatry. 2005 Sep;13(9):748-55. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Hamilton Depression Rating Scale
Primary Scale for Suicide Ideation
Secondary All cause and cause-specific mortality
Secondary disability (Sf12; instrumental activities of daily living)
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