StrokePhase 4NCT00029172
Treatment for Post-Stroke Depression
A Phase 4 study testing case management in people with Stroke and Depression, run by Indiana University at 4 sites in United States.
Trial summary
The purpose of this study is to evaluate a program of education, medicine, and monitoring for the treatment of depression after a stroke. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Stroke, Depression
- What is being tested?
- case management
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 188 participants
- Where
- 4 sitesUnited States
- Study dates
- May 1999to Dec 2005
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
- No severe language or cognitive deficits,
- life expectancy of at least 9 months, and
- willingness to participate.
Trial locations and contacts
4 sites in 1 country.
United States4 sites
Indiana University Hospital, 550 N. University Blvd.
Indianapolis, Indiana, 46202
Methodist Hospital of Indiana, 1601 N. Capitol
Indianapolis, Indiana, 46202
Roudebush VA Medical Center, Health Services Research and Development 11H, 1481 W. 10th Street
Indianapolis, Indiana, 46202
Wishard Memorial Hospital, 1001 W. 10th Street
Indianapolis, Indiana, 46202
About this study
The purpose of this study is to evaluate a program of education, medicine, and monitoring for the treatment of depression after a stroke.
Read the detailed description
This trial will compare outcomes in depressed patients receiving the Activate-Initiate-Monitor (AIM) intervention vs. those receiving usual care, and will also compare outcomes in depressed and non-depressed stroke survivors. Patients are screened for depression 1 to 2 months post-stroke. Patients with depression are then randomized to the AIM intervention or control group. Patients without depression are also enrolled at the same time and are matched by hospital site to the depressed patients.
The AIM intervention is a 3-part program consisting of activating or educating the patient and his/her family about post-stroke depression, instituting treatment for depression, and monitoring antidepressant treatments for side effects, efficacy, and compliance. Control patients are evaluated and treated with usual care by their physicians. Patients without depression do not receive the intervention but complete the same assessments on the same schedule as the patients with depression.
- Conditions
- Stroke, Depression
- Being tested
- case management
- Keywords
- stroke, depression
- Medical subject headings
- Stroke, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
case managementOther
| Study group | Role | What they receive |
|---|---|---|
| Nurse Case management | Experimental | Not described Receives: Other: case management |
What is being measured
The primary outcome is the main question the study is designed to answer.
Twelve Week Depression Outcomes
Depression remission was defined as HAM-D less than 8 or HAM-D decreased by 50%.
The Hamilton Rating Scale for Depression is measured on a scale from no depression - major depression, 0-52 units on a scale.
Measured: Twelve week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jan 2002 (estimated)
- Study startMay 1999
- Study completionDec 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for StrokeStudies 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
- Treatment
- Allocation
- Randomised
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 188 participants (actual)
Sponsor and investigators
- Lead sponsor
- Indiana University
- Sponsor type
- University, hospital or other
- Investigators
- Linda Williams, M.D., Principal investigator, Roudebush VA Medical Center Health Services Research and Development 11H
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00029172
- Sponsor's protocol ID
- 9903-06
- Status last verified
- Dec 2009
- First submitted
- 8 Jan 2002
- Last updated
- 16 Feb 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
Williams LS, Brizendine EJ, Plue L, Bakas T, Tu W, Hendrie H, Kroenke K. Performance of the PHQ-9 as a screening tool for depression after stroke. Stroke. 2005 Mar;36(3):635-8. doi: 10.1161/01.STR.0000155688.18207.33. Epub 2005 Jan 27.
PubMed 15677576Williams LS, Bakas T, Brizendine E, Plue L, Tu W, Hendrie H, Kroenke K. How valid are family proxy assessments of stroke patients' health-related quality of life? Stroke. 2006 Aug;37(8):2081-5. doi: 10.1161/01.STR.0000230583.10311.9f. Epub 2006 Jun 29.
PubMed 16809575Williams LS, Kroenke K, Bakas T, Plue LD, Brizendine E, Tu W, Hendrie H. Care management of poststroke depression: a randomized, controlled trial. Stroke. 2007 Mar;38(3):998-1003. doi: 10.1161/01.STR.0000257319.14023.61. Epub 2007 Feb 15.
PubMed 17303771
Study at a glance
From the registry record, last updated by the sponsor on 16 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Treatment for Post-Stroke Depression
- ClinicalTrials.gov ID
- NCT00029172
- Acronym / sponsor ID
- 9903-06
- Conditions
- Stroke, Depression
- Keywords
- stroke, depression
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 188 participants (actual)
- Lead sponsor
- Indiana UniversityUniversity, hospital or other
- Study start
- May 1999
- Study completion
- Dec 2005 (actual)
- First posted
- 9 Jan 2002 (estimated)
- Results
- Posted 28 Jan 2010
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 evaluate a program of education, medicine, and monitoring for the treatment of depression after a stroke.
Detailed description
This trial will compare outcomes in depressed patients receiving the Activate-Initiate-Monitor (AIM) intervention vs. those receiving usual care, and will also compare outcomes in depressed and non-depressed stroke survivors. Patients are screened for depression 1 to 2 months post-stroke. Patients with depression are then randomized to the AIM intervention or control group. Patients without depression are also enrolled at the same time and are matched by hospital site to the depressed patients.
The AIM intervention is a 3-part program consisting of activating or educating the patient and his/her family about post-stroke depression, instituting treatment for depression, and monitoring antidepressant treatments for side effects, efficacy, and compliance. Control patients are evaluated and treated with usual care by their physicians. Patients without depression do not receive the intervention but complete the same assessments on the same schedule as the patients with depression.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Nurse Case management | Experimental | Other: case management |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
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 |
|---|---|---|
| case management | Other | Nurse Case management |
Primary outcome
Twelve Week Depression Outcomes
Time frame: Twelve week
Depression remission was defined as HAM-D less than 8 or HAM-D decreased by 50%. The Hamilton Rating Scale for Depression is measured on a scale from no depression - major depression, 0-52 units on a scale.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Feb 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 15677576Williams LS, Brizendine EJ, Plue L, Bakas T, Tu W, Hendrie H, Kroenke K. Performance of the PHQ-9 as a screening tool for depression after stroke. Stroke. 2005 Mar;36(3):635-8. doi: 10.1161/01.STR.0000155688.18207.33. Epub 2005 Jan 27.
- Background: PubMed 16809575Williams LS, Bakas T, Brizendine E, Plue L, Tu W, Hendrie H, Kroenke K. How valid are family proxy assessments of stroke patients' health-related quality of life? Stroke. 2006 Aug;37(8):2081-5. doi: 10.1161/01.STR.0000230583.10311.9f. Epub 2006 Jun 29.
- Results publication: PubMed 17303771Williams LS, Kroenke K, Bakas T, Plue LD, Brizendine E, Tu W, Hendrie H. Care management of poststroke depression: a randomized, controlled trial. Stroke. 2007 Mar;38(3):998-1003. doi: 10.1161/01.STR.0000257319.14023.61. Epub 2007 Feb 15.
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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.
Linda Williams, M.D. principal investigator
Roudebush VA Medical Center Health Services Research and Development 11H
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing case management in people with Stroke and Depression, run by Indiana University at 4 sites in United States.
The full registered description is in the About this study section and the official record.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 28 Jan 2010). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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.
What does the primary outcome measure?
Twelve Week Depression Outcomes (time frame: Twelve week). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00029172, 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 16 Feb 2023.