DepressionNCT00000367
Prevention of Suicide in the Elderly
A study testing Treatment of depression, Suicide prevention intervention and Suicide prevention treatment in people with Depression, run by Weill Medical College of Cornell University at 1 site in United States.
Trial summary
The purpose of this study is to design a program to prevent suicide in elderly patients by educating patients, their families, and physicians on depression and suicidal thoughts. A program to prevent suicide in elderly patients needs to be developed. Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- Depression
- What is being tested?
- Treatment of depression, Suicide prevention intervention and Suicide prevention treatment
- Type of treatment
- Lifestyle or therapy programme
- How many people
- Not given
- Where
- 1 siteUnited States
- Study dates
- Sep 1998to Aug 2003
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- -
- Patients must have:
- Depressive symptoms and signs. (Required for 920 of the 1200 patients; 280 patients should have no significant depressive symptomatology.)
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
United States1 site
New York Presbyterian Hospital/Westchester Division
White Plains, New York, 10605
About this study
The purpose of this study is to design a program to prevent suicide in elderly patients by educating patients, their families, and physicians on depression and suicidal thoughts.
A program to prevent suicide in elderly patients needs to be developed. Since elderly patients frequently have doctor's visits, it may be best to have a suicide prevention program based in the patient's doctor's office.
Read more
When an older person visits a primary care physician, he/she will check for signs of depression, including thoughts of suicide. The doctor will speak to the patient about depression and how to recognize it. If the individual is diagnosed with depression, the doctor will offer treatment. During this study, the information the doctor collects will be used to evaluate the effectiveness of the program. The study will last for 2 years.
Eligibility for this study is age of at least 60 years and diagnosis of depression. (Depression required for 920 of the 1200 patients; 280 patients should have no symptoms of depression.)
Read the detailed description
To investigate the effectiveness of an intervention aimed at improving the recognition of suicidal ideation and depression in elderly patients and facilitating the implementation of a treatment algorithm based on the AHCPR (Agency for Health Care Policy and Research) guidelines. To implement procedures aimed at educating patients, families, and physicians on depression and suicidal ideation.
There is a need to test models of depression recognition and treatment to prevent and reduce suicidal behavior in older patients in primary care settings. Elderly suicide most frequently occurs in the context of mild to moderate depression. In primary care patients, suicidal ideation is a risk factor for suicide and has been identified almost exclusively in patients with depressive symptoms and signs. Since most suicide victims are seen by their primary care physicians within a few weeks prior to their death, intervening at the doctor's office may be life-saving.
The intervention is offered in 6 primary care practices from 3 geographic areas (metropolitan and suburban New York, Philadelphia, and Pittsburgh) and its impact is contrasted to that of 6 comparable practices offering usual care. Patients are selected through an age-stratified, two-stage sampling design and followed for 2 years. The group consists of 1,200 subjects and is comprised of patients with depressive symptoms and signs and a random sample of patients without significant depressive symptomatology. Depression Specialists (DS) collaborate with physicians and help them increase recognition, offer timely and appropriately-targeted treatment recommendations, and encourage patients to adhere to treatment. Beyond direct systematic clinical assessment of patients, information is obtained on health services utilization from practice-based medical records and on cause of death from death certificates. Data are also collected to document the impact of intervention on patient care, and on physician knowledge, attitudes, and satisfaction and test hypotheses derived from preliminary studies of the three Intervention Research Centers (IRCs), Cornell, University of Pennsylvania, and University of Pittsburgh, where the study will be conducted.
- Conditions
- Depression
- Being tested
- Treatment of depression, Suicide prevention intervention, Suicide prevention treatment
- Keywords
- Depression, Family, Female, Human, Male, Practice Guidelines, Education, Medical, Continuing, Patient Education, Suicide
- Medical subject headings
- Depression, Suicide
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Treatment of depressionDrug
Suicide prevention interventionBehavioural
Suicide prevention treatmentDrug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Nov 1999 (estimated)
- Study startSep 1998
- Study completionAug 2003
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for DepressionStudies of the same condition, open and under way.
- More trials run by Weill Medical College of Cornell UniversityThe sponsor's other registered studies.
- 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 N/A
- Primary purpose
- Prevention
Sponsor and investigators
- Lead sponsor
- Weill Medical College of Cornell University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Investigators
- George Alexopoulos, MD, Principal investigator
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00000367
- Sponsor's protocol ID
- R01MH059366
- Other IDs
- R01MH059366, DSIR AT-P
- Status last verified
- Oct 2013
- First submitted
- 2 Nov 1999
- Last updated
- 29 Oct 2013
- Results posted
- No
Publications
Gallo JJ, Hwang S, Joo JH, Bogner HR, Morales KH, Bruce ML, Reynolds CF 3rd. Multimorbidity, Depression, and Mortality in Primary Care: Randomized Clinical Trial of an Evidence-Based Depression Care Management Program on Mortality Risk. J Gen Intern Med. 2016 Apr;31(4):380-6. doi: 10.1007/s11606-015-3524-y. Epub 2015 Oct 2.
PubMed 26432693Gallo JJ, Morales KH, Bogner HR, Raue PJ, Zee J, Bruce ML, Reynolds CF 3rd. Long term effect of depression care management on mortality in older adults: follow-up of cluster randomized clinical trial in primary care. BMJ. 2013 Jun 5;346:f2570. doi: 10.1136/bmj.f2570.
PubMed 23738992Gallo JJ, Bogner HR, Morales KH, Post EP, Lin JY, Bruce ML. The effect of a primary care practice-based depression intervention on mortality in older adults: a randomized trial. Ann Intern Med. 2007 May 15;146(10):689-98. doi: 10.7326/0003-4819-146-10-200705150-00002.
PubMed 17502629
Study at a glance
From the registry record, last updated by the sponsor on 29 Oct 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prevention of Suicide in the Elderly
- ClinicalTrials.gov ID
- NCT00000367
- Acronym / sponsor ID
- R01MH059366
- Conditions
- Depression
- Keywords
- Depression, Family, Female, Human, Male, Practice Guidelines, Education, Medical, Continuing, Patient Education
- Study type
- Interventional
- Recruitment status
- Completed
- Lead sponsor
- Weill Medical College of Cornell UniversityUniversity, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Study start
- Sep 1998
- Study completion
- Aug 2003
- First posted
- 3 Nov 1999 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to design a program to prevent suicide in elderly patients by educating patients, their families, and physicians on depression and suicidal thoughts.
A program to prevent suicide in elderly patients needs to be developed. Since elderly patients frequently have doctor's visits, it may be best to have a suicide prevention program based in the patient's doctor's office.
When an older person visits a primary care physician, he/she will check for signs of depression, including thoughts of suicide. The doctor will speak to the patient about depression and how to recognize it. If the individual is diagnosed with depression, the doctor will offer treatment. During this study, the information the doctor collects will be used to evaluate the effectiveness of the program. The study will last for 2 years.
Eligibility for this study is age of at least 60 years and diagnosis of depression. (Depression required for 920 of the 1200 patients; 280 patients should have no symptoms of depression.)
Detailed description
To investigate the effectiveness of an intervention aimed at improving the recognition of suicidal ideation and depression in elderly patients and facilitating the implementation of a treatment algorithm based on the AHCPR (Agency for Health Care Policy and Research) guidelines. To implement procedures aimed at educating patients, families, and physicians on depression and suicidal ideation.
There is a need to test models of depression recognition and treatment to prevent and reduce suicidal behavior in older patients in primary care settings. Elderly suicide most frequently occurs in the context of mild to moderate depression. In primary care patients, suicidal ideation is a risk factor for suicide and has been identified almost exclusively in patients with depressive symptoms and signs. Since most suicide victims are seen by their primary care physicians within a few weeks prior to their death, intervening at the doctor's office may be life-saving.
The intervention is offered in 6 primary care practices from 3 geographic areas (metropolitan and suburban New York, Philadelphia, and Pittsburgh) and its impact is contrasted to that of 6 comparable practices offering usual care. Patients are selected through an age-stratified, two-stage sampling design and followed for 2 years. The group consists of 1,200 subjects and is comprised of patients with depressive symptoms and signs and a random sample of patients without significant depressive symptomatology. Depression Specialists (DS) collaborate with physicians and help them increase recognition, offer timely and appropriately-targeted treatment recommendations, and encourage patients to adhere to treatment. Beyond direct systematic clinical assessment of patients, information is obtained on health services utilization from practice-based medical records and on cause of death from death certificates. Data are also collected to document the impact of intervention on patient care, and on physician knowledge, attitudes, and satisfaction and test hypotheses derived from preliminary studies of the three Intervention Research Centers (IRCs), Cornell, University of Pennsylvania, and University of Pittsburgh, where the study will be conducted.
Study design
- Primary purpose
- Prevention
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- -
- Depressive symptoms and signs. (Required for 920 of the 1200 patients; 280 patients should have no significant depressive symptomatology.)
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Treatment of depression | Drug | – |
| Suicide prevention intervention | Behavioural | – |
| Suicide prevention treatment | Drug | – |
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Oct 2013.
- Derived from this study: PubMed 26432693Gallo JJ, Hwang S, Joo JH, Bogner HR, Morales KH, Bruce ML, Reynolds CF 3rd. Multimorbidity, Depression, and Mortality in Primary Care: Randomized Clinical Trial of an Evidence-Based Depression Care Management Program on Mortality Risk. J Gen Intern Med. 2016 Apr;31(4):380-6. doi: 10.1007/s11606-015-3524-y. Epub 2015 Oct 2.
- Derived from this study: PubMed 23738992Gallo JJ, Morales KH, Bogner HR, Raue PJ, Zee J, Bruce ML, Reynolds CF 3rd. Long term effect of depression care management on mortality in older adults: follow-up of cluster randomized clinical trial in primary care. BMJ. 2013 Jun 5;346:f2570. doi: 10.1136/bmj.f2570.
- Derived from this study: PubMed 17502629Gallo JJ, Bogner HR, Morales KH, Post EP, Lin JY, Bruce ML. The effect of a primary care practice-based depression intervention on mortality in older adults: a randomized trial. Ann Intern Med. 2007 May 15;146(10):689-98. doi: 10.7326/0003-4819-146-10-200705150-00002.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
George Alexopoulos, MD principal investigator
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Treatment of depression, Suicide prevention intervention and Suicide prevention treatment in people with Depression, run by Weill Medical College of Cornell University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Oct 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00000367, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Oct 2013.