DepressionNCT00442429
Morbidity and Mortality Among Dialysis Patients After Treatment for Depression
An observational study of Depression and ESRD, run by Portland VA Medical Center at 1 site in United States.
Trial summary
Morbidity and Mortality among Dialysis Patients after Treating Depression Objectives Our investigation has two objectives: 1. To assess whether treatment and recovery from depression decreases adverse clinical events in chronic hemodialysis patients. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Depression, ESRD
- How many people
- 350 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2004to Jun 2010
- Phase
- Observational
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- ESRD age > 18
Who cannot join
- non english speaking, another psychiatric dx aside from depression
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Portland VA MC
Portland, Oregon, 97239
suzanne watnick
About this study
Morbidity and Mortality among Dialysis Patients after Treating Depression
Objectives
Read more
Our investigation has two objectives:
- To assess whether treatment and recovery from depression decreases adverse clinical events in chronic hemodialysis patients. Significant morbidity is associated with depression in dialysis patients, but subsequent impact on outcome after treatment of depression has not been reported.
- To examine the rates of recovery from depression over a 6-month and 12-month period among prevalent dialysis patients. Rates of recovery among dialysis patients with depression are unclear. The natural history of depression among dialysis patients may help long-term management.
Plan and Methods
This project is a longitudinal prospective cohort study comprised of dialysis patients from outpatient dialysis units in the Portland, Oregon metropolitan area. Patients must be aged 18 or older and have started dialysis at least 90 days prior to enrollment. Patients are excluded if they are delirious, demented, cannot speak English, or have a prior psychiatric diagnosis other than depression. Baseline data collection includes patient demographics, etiology of renal disease, nutritional status, past medical and psychiatric history and baseline health status. Social support and quality of life assessments are obtained from direct interview. All patients are assessed for depression by the Beck Depression Index, a depression scale particularly useful in those with chronic illness, and the Diagnostic Interview Scale, a gold standard for depression assessment.
Those that are depressed will undergo pharmacologic treatment with an SSRI, if they agree, and be reassessed at 2 and 6 months for improvement. Patients who do not respond are referred for psychiatric therapy. The primary outcome of our study is the combined rate of prespecified morbidity and mortality at 18 months between two groups: depressed subjects agreeing to treatment and depressed subjects not agreeing to treatment. Prespecified morbidities include rates of 1) cardiovascular and cerebrovascular events, 2) infections, 3) vascular access complications, and 4) death. These were selected based on prior studies suggesting that depression increases cardiovascular and cerebrovascular events, suppresses the immune system, and up-regulates coagulation factors and platelet aggregation. , , , , , ,
Chi-square tests and T-tests will be used to compare baseline variables among those who are and are not depressed. A multivariable Cox proportional hazards model will compare survival among groups, with adjustments for baseline variables. Calculations derived from the Neyman-Pearson equation determined a sample size of 120 subjects.
Findings to date
We have enrolled 134 subjects to date, including 47 from the PVAMC, and 87 from outside dialysis units. Twenty-percent of them have been depressed. (We need to enroll 120 depressed patients.) No further results have been obtained this year. No further characteristics have been analyzed to date. All adverse events have been reported, none were unexpected.
Significance
We hope to demonstrate a reduction in adverse clinical outcomes with treatment of depression. If so, we would advocate that depression is a modifiable risk factor that warrants therapy for well-being in dialysis patients.
Read the detailed description
Morbidity and Mortality among Dialysis Patients after Treating Depression
Objectives
Our investigation has two objectives:
- To assess whether treatment and recovery from depression decreases adverse clinical events in chronic hemodialysis patients. Significant morbidity is associated with depression in dialysis patients, but subsequent impact on outcome after treatment of depression has not been reported.
- To examine the rates of recovery from depression over a 6-month and 12-month period among prevalent dialysis patients. Rates of recovery among dialysis patients with depression are unclear. The natural history of depression among dialysis patients may help long-term management.
Plan and Methods
This project is a longitudinal prospective cohort study comprised of dialysis patients from outpatient dialysis units in the Portland, Oregon metropolitan area. Patients must be aged 18 or older and have started dialysis at least 90 days prior to enrollment. Patients are excluded if they are delirious, demented, cannot speak English, or have a prior psychiatric diagnosis other than depression. Baseline data collection includes patient demographics, etiology of renal disease, nutritional status, past medical and psychiatric history and baseline health status. Social support and quality of life assessments are obtained from direct interview. All patients are assessed for depression by the Beck Depression Index, a depression scale particularly useful in those with chronic illness, and the Diagnostic Interview Scale, a gold standard for depression assessment.
Those that are depressed will undergo pharmacologic treatment with an SSRI, if they agree, and be reassessed at 2 and 6 months for improvement. Patients who do not respond are referred for psychiatric therapy. The primary outcome of our study is the combined rate of prespecified morbidity and mortality at 18 months between two groups: depressed subjects agreeing to treatment and depressed subjects not agreeing to treatment. Prespecified morbidities include rates of 1) cardiovascular and cerebrovascular events, 2) infections, 3) vascular access complications, and 4) death. These were selected based on prior studies suggesting that depression increases cardiovascular and cerebrovascular events, suppresses the immune system, and up-regulates coagulation factors and platelet aggregation. , , , , , ,
Chi-square tests and T-tests will be used to compare baseline variables among those who are and are not depressed. A multivariable Cox proportional hazards model will compare survival among groups, with adjustments for baseline variables. Calculations derived from the Neyman-Pearson equation determined a sample size of 120 subjects.
Findings to date
We have enrolled 134 subjects to date, including 47 from the PVAMC, and 87 from outside dialysis units. Twenty-percent of them have been depressed. (We need to enroll 120 depressed patients.) No further results have been obtained this year. No further characteristics have been analyzed to date. All adverse events have been reported, none were unexpected.
Significance
We hope to demonstrate a reduction in adverse clinical outcomes with treatment of depression. If so, we would advocate that depression is a modifiable risk factor that warrants therapy for well-being in dialysis patients.
- Conditions
- Depression, ESRD
- Keywords
- depression; dialysis; kidney failure, chronic
- Medical subject headings
- Depression, Kidney Failure, Chronic, Renal Insufficiency, Bronchiolitis Obliterans Syndrome
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Mar 2007 (estimated)
- Study startJul 2004
- Study completionJun 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Observational
- Observational model
- Defined population
- Time perspective
- Prospective
- Enrolment
- 350 participants
Sponsor and investigators
- Lead sponsor
- Portland VA Medical Center
- Sponsor type
- US federal agency
- Collaborators
- Medical Research Foundation, Oregon
- Investigators
- suzanne watnick, MD, Principal investigator, PVAMC physician
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00442429
- Sponsor's protocol ID
- 00898
- Status last verified
- Mar 2007
- First submitted
- 1 Mar 2007
- Last updated
- 2 Mar 2007
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Mar 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Morbidity and Mortality Among Dialysis Patients After Treatment for Depression
- ClinicalTrials.gov ID
- NCT00442429
- Acronym / sponsor ID
- 00898
- Conditions
- Depression, ESRD
- Keywords
- depression; dialysis; kidney failure, chronic
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 350 participants
- Lead sponsor
- Portland VA Medical CenterUS federal agency
- Collaborators
- Medical Research Foundation, Oregon
- Study start
- Jul 2004
- Study completion
- Jun 2010
- First posted
- 2 Mar 2007 (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.
Morbidity and Mortality among Dialysis Patients after Treating Depression
Objectives
Our investigation has two objectives:
- To assess whether treatment and recovery from depression decreases adverse clinical events in chronic hemodialysis patients. Significant morbidity is associated with depression in dialysis patients, but subsequent impact on outcome after treatment of depression has not been reported.
- To examine the rates of recovery from depression over a 6-month and 12-month period among prevalent dialysis patients. Rates of recovery among dialysis patients with depression are unclear. The natural history of depression among dialysis patients may help long-term management.
Plan and Methods
This project is a longitudinal prospective cohort study comprised of dialysis patients from outpatient dialysis units in the Portland, Oregon metropolitan area. Patients must be aged 18 or older and have started dialysis at least 90 days prior to enrollment. Patients are excluded if they are delirious, demented, cannot speak English, or have a prior psychiatric diagnosis other than depression. Baseline data collection includes patient demographics, etiology of renal disease, nutritional status, past medical and psychiatric history and baseline health status. Social support and quality of life assessments are obtained from direct interview. All patients are assessed for depression by the Beck Depression Index, a depression scale particularly useful in those with chronic illness, and the Diagnostic Interview Scale, a gold standard for depression assessment.
Those that are depressed will undergo pharmacologic treatment with an SSRI, if they agree, and be reassessed at 2 and 6 months for improvement. Patients who do not respond are referred for psychiatric therapy. The primary outcome of our study is the combined rate of prespecified morbidity and mortality at 18 months between two groups: depressed subjects agreeing to treatment and depressed subjects not agreeing to treatment. Prespecified morbidities include rates of 1) cardiovascular and cerebrovascular events, 2) infections, 3) vascular access complications, and 4) death. These were selected based on prior studies suggesting that depression increases cardiovascular and cerebrovascular events, suppresses the immune system, and up-regulates coagulation factors and platelet aggregation. , , , , , ,
Chi-square tests and T-tests will be used to compare baseline variables among those who are and are not depressed. A multivariable Cox proportional hazards model will compare survival among groups, with adjustments for baseline variables. Calculations derived from the Neyman-Pearson equation determined a sample size of 120 subjects.
Findings to date
We have enrolled 134 subjects to date, including 47 from the PVAMC, and 87 from outside dialysis units. Twenty-percent of them have been depressed. (We need to enroll 120 depressed patients.) No further results have been obtained this year. No further characteristics have been analyzed to date. All adverse events have been reported, none were unexpected.
Significance
We hope to demonstrate a reduction in adverse clinical outcomes with treatment of depression. If so, we would advocate that depression is a modifiable risk factor that warrants therapy for well-being in dialysis patients.
Detailed description
Morbidity and Mortality among Dialysis Patients after Treating Depression
Objectives
Our investigation has two objectives:
- To assess whether treatment and recovery from depression decreases adverse clinical events in chronic hemodialysis patients. Significant morbidity is associated with depression in dialysis patients, but subsequent impact on outcome after treatment of depression has not been reported.
- To examine the rates of recovery from depression over a 6-month and 12-month period among prevalent dialysis patients. Rates of recovery among dialysis patients with depression are unclear. The natural history of depression among dialysis patients may help long-term management.
Plan and Methods
This project is a longitudinal prospective cohort study comprised of dialysis patients from outpatient dialysis units in the Portland, Oregon metropolitan area. Patients must be aged 18 or older and have started dialysis at least 90 days prior to enrollment. Patients are excluded if they are delirious, demented, cannot speak English, or have a prior psychiatric diagnosis other than depression. Baseline data collection includes patient demographics, etiology of renal disease, nutritional status, past medical and psychiatric history and baseline health status. Social support and quality of life assessments are obtained from direct interview. All patients are assessed for depression by the Beck Depression Index, a depression scale particularly useful in those with chronic illness, and the Diagnostic Interview Scale, a gold standard for depression assessment.
Those that are depressed will undergo pharmacologic treatment with an SSRI, if they agree, and be reassessed at 2 and 6 months for improvement. Patients who do not respond are referred for psychiatric therapy. The primary outcome of our study is the combined rate of prespecified morbidity and mortality at 18 months between two groups: depressed subjects agreeing to treatment and depressed subjects not agreeing to treatment. Prespecified morbidities include rates of 1) cardiovascular and cerebrovascular events, 2) infections, 3) vascular access complications, and 4) death. These were selected based on prior studies suggesting that depression increases cardiovascular and cerebrovascular events, suppresses the immune system, and up-regulates coagulation factors and platelet aggregation. , , , , , ,
Chi-square tests and T-tests will be used to compare baseline variables among those who are and are not depressed. A multivariable Cox proportional hazards model will compare survival among groups, with adjustments for baseline variables. Calculations derived from the Neyman-Pearson equation determined a sample size of 120 subjects.
Findings to date
We have enrolled 134 subjects to date, including 47 from the PVAMC, and 87 from outside dialysis units. Twenty-percent of them have been depressed. (We need to enroll 120 depressed patients.) No further results have been obtained this year. No further characteristics have been analyzed to date. All adverse events have been reported, none were unexpected.
Significance
We hope to demonstrate a reduction in adverse clinical outcomes with treatment of depression. If so, we would advocate that depression is a modifiable risk factor that warrants therapy for well-being in dialysis patients.
Study design
- Observational model
- Defined population
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- ESRD age > 18
Key exclusion criteria (1 listed)
- non english speaking, another psychiatric dx aside from depression
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Mar 2007.
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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.
suzanne watnick, MD principal investigator
PVAMC physician
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Depression and ESRD, run by Portland VA Medical Center 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 1 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 2 Mar 2007. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact suzanne g watnick, MD (503-220-8262, suzanne.watnick@med.va.gov), or a site near the patient. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
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 2 Mar 2007; AzTrials last refreshed its copy on 8 Nov 2026.