DepressionPhase 4NCT00279682
Prevention of Suicide in Primary Care Elderly: Collaborative Trial (PROSPECT)
A Phase 4 study testing treatment guidelines and depression care management in people with Depression and Suicide, Attempted, run by Weill Medical College of Cornell University at 3 sites in United States.
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. Read more about this study
- Who is it for?
- Ages 60 years and olderHealthy volunteers can take part
- Conditions the study is for
- Depression, Suicide, Attempted
- What is being tested?
- treatment guidelines and depression care management
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 1,200 participants
- Where
- 3 sitesUnited States
- Study dates
- May 1999to Aug 2003
- Phase
- Phase 4
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
Who may be able to join
- upcoming appointment with primary care clinician
Who cannot join
- inability to give consent
- minimental status examination <18
- ability to communicate in English
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Universilty of Pennsylvania
Philadelphia, Pennsylvania, 19104
University of Pittsburgh
Pittsburgh, Pennsylvania, 15213
Weill Medical College of Cornell University
White Plains, New York, 10506
About this study
Official title: Prevention of Suicide in Primary Care Elderly: Collaborative Trial
The purpose of this study was to determine the effect of a primary care intervention on reducing suicidal ideation and depression in older patients.
Read the detailed 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.
- Conditions
- Depression, Suicide, Attempted
- Being tested
- treatment guidelines and depression care management
- Keywords
- depression, suicide, geriatric, elderly, primary care
- Medical subject headings
- Depression, Suicide, Attempted, Suicide
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
treatment guidelines and depression care managementBehavioural
What is being measured
The primary outcome is the main question the study is designed to answer.
Hamilton Depression Rating Scale
Scale for Suicide Ideation
Secondary outcomes (2)
All cause and cause-specific mortality
disability (Sf12; instrumental activities of daily living)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jan 2006 (estimated)
- Study startMay 1999
- Study completionAug 2003
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)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
- Interventional
- Phase
- Phase 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 1,200 participants
Sponsor and investigators
- Lead sponsor
- Weill Medical College of Cornell University
- Sponsor type
- University, hospital or other
- Collaborators
- University of Pennsylvania, University of Pittsburgh, National Institute of Mental Health (NIMH), Forest Laboratories, The John A. Hartford Foundation
- Investigators
- George S Alexopoulos, MD, Principal investigator, Weill Medical College of Cornell UniversityIra Katz, MD. Ph.D., Principal investigator, University of PennsylvaniaCharles F Reynolds, MD, Principal investigator, University of Pittsburgh
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00279682
- Sponsor's protocol ID
- R01MH059366
- Other IDs
- R01MH059380, R01MH059381
- Status last verified
- Jan 2006
- First submitted
- 17 Jan 2006
- Last updated
- 19 Jan 2006
- Results posted
- No
Publications
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. doi: 10.31887/DCNS.1999.1.2/mbruce.
PubMed 22033641Bruce 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. 2004 Mar 3;291(9):1081-91. doi: 10.1001/jama.291.9.1081.
PubMed 14996777Alexopoulos 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):718-24. doi: 10.1176/appi.ajp.162.4.718.
PubMed 15800144Gallo 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. doi: 10.1176/appi.ajgp.13.9.748.
PubMed 16166403Gallo JJ, Hwang S, Truong C, Reynolds CF, Spira AP. Role of persistent and worsening sleep disturbance in depression remission and suicidal ideation among older primary care patients: the PROSPECT study. Sleep. 2020 Oct 13;43(10):zsaa063. doi: 10.1093/sleep/zsaa063.
PubMed 32239161Gilman SE, Fitzmaurice GM, Bruce ML, Ten Have T, Glymour MM, Carliner H, Alexopoulos GS, Mulsant BH, Reynolds CF 3rd, Cohen A. Economic inequalities in the effectiveness of a primary care intervention for depression and suicidal ideation. Epidemiology. 2013 Jan;24(1):14-22. doi: 10.1097/EDE.0b013e3182762403.
PubMed 23232609Bao Y, Alexopoulos GS, Casalino LP, Ten Have TR, Donohue JM, Post EP, Schackman BR, Bruce ML. Collaborative depression care management and disparities in depression treatment and outcomes. Arch Gen Psychiatry. 2011 Jun;68(6):627-36. doi: 10.1001/archgenpsychiatry.2011.55.
PubMed 21646579Alexopoulos GS, Reynolds CF 3rd, Bruce ML, Katz IR, Raue PJ, Mulsant BH, Oslin DW, Ten Have T; PROSPECT Group. Reducing suicidal ideation and depression in older primary care patients: 24-month outcomes of the PROSPECT study. Am J Psychiatry. 2009 Aug;166(8):882-90. doi: 10.1176/appi.ajp.2009.08121779. Epub 2009 Jun 15.
PubMed 19528195