Cerebrovascular AccidentPhase 4NCT00177424
Sertraline for Preventing Post-stroke Depression and Improving Rehabilitation Outcomes
A Phase 4 study testing sertraline in people with Cerebrovascular Accident and Depression, run by University of Pittsburgh at 1 site in United States.
Trial summary
This study will determine the effectiveness of sertraline administration after a stroke in preventing the onset of post-stroke depression. Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- Cerebrovascular Accident, Depression
- What is being tested?
- sertraline
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 154 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2004to Oct 2007
- Phase
- Phase 4
- 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 40 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Ischemic stroke within 3 months of study entry
- Admitted to a UPMC hospital for acute inpatient treatment or rehabilitation of stroke
- Speaks English
- Females willing to use an effective form of birth control throughout the study
Who cannot join
- Meets DSM-IV-TR criteria for a major depressive episode
- History of any bipolar disorder
- Psychotic or history of a psychotic disorder
- Meets DMS-IV TR criteria for alcohol or substance abuse or dependence criteria within 3 months of study entry
- Current treatment with antidepressant medication for any reason (e.g., anxiety disorder, neuropathic pain)
- Primary hemorrhagic stroke
Show all 14Show fewer
- Language impairment severe enough to prevent valid neuropsychiatric assessment
- History of another CNS disease other than prior stroke or psychiatric illness (e.g., head trauma, multiple sclerosis, HIV with CNS involvement)
- Pulse <50 or >100 beats per minute
- Significant hyponatremia (Na <130meq)
- Current hypothyroid state
- Medically unstable including symptoms of delirium (determined by review of the subject's medical status with the treating (clinical) physician; standard blood chemistry lab work will be obtained if not checked within the preceding 30 days)
- History of sensitivity to sertraline
- Pregnant or breastfeeding
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, 15213
About this study
Official title: Intervention to Prevent Post-Stroke Major Depression.
This study will determine the effectiveness of sertraline administration after a stroke in preventing the onset of post-stroke depression.
Read the detailed description
Persons who suffer from a stroke are at high risk for developing post-stroke major depression (PSMD), an illness that has a negative impact on post-stroke physical rehabilitation and is associated with increased morbidity and mortality. Unfortunately, early detection and successful treatment of post-stroke major depression improves, but does not normalize, stroke rehabilitation outcomes compared to stroke survivors who never developed post-stroke depression. Therefore, preventing the onset of PSMD and its associated disability is an attractive possibility. This study is a placebo controlled, 10-month double-blind trial of sertraline in the prevention of PSMD in stroke survivors, with a 2-month naturalistic continuation phase. The primary outcome will be the incidence of Major Depression post-stroke. Additional outcomes will include the severity of depressive symptoms post-stroke and the level of disability experienced by the two treatment groups. An exploratory analysis will also be conducted to elucidate participant characteristics that may be moderators of the participants' response to the preventive intervention, thereby refining the profile of disabled stroke survivors most likely to benefit from the preventive intervention.
For information on a related study, please follow this link:
http://clinicaltrials.gov/show/NCT00781326
- Conditions
- Cerebrovascular Accident, Depression
- Being tested
- sertraline, Placebo
- Keywords
- Rehabilitation
- Medical subject headings
- Stroke, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
sertralineDrug
Subjects will initially be started on either sertraline 12.5mg/d or placebo and will receive this dose for 3 days. Subjects will then be increased to 25mg/d for 4 days, then 50mg/d for 7 days, then increased to 75mg/d. Seventy-five mg per day is the target dose for the remainder of the subject's participation in the study. The study medication will not be titrated past 75mg/d.
PlaceboDrug
matching placebo tablets
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | Sertraline Receives: Drug: sertraline |
| 2 | Placebo comparator | matching placebo Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary outcome will be the incidence of Major Depression post-stroke.
Measured: 12 months
Secondary outcomes (1)
Additional outcomes will include the severity of depressive symptoms post-stroke as measured by the Hamilton Depression Rating Scale, and the level of disability experienced by the two treatment groups, as measured by the Functional Independence Measure.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Sep 2005 (estimated)
- Study startJul 2004
- Primary completionOct 2007
- Study completionOct 2007
Why it stopped: Recruitment goals could not be met.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cerebrovascular AccidentStudies of the same condition, open and under way.
- More trials run by University of PittsburghThe 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 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 154 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Pittsburgh
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Responsible party
- Sponsor
- Investigators
- Ellen M Whyte, MD, Principal investigator, University of Pittsburgh
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00177424
- Sponsor's protocol ID
- K23MH067710-02
- Other IDs
- K23MH067710-02, 0310068, DATR AK-TNGP1
- Status last verified
- Feb 2009
- First submitted
- 12 Sep 2005
- Last updated
- 27 Jun 2014
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Jun 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intervention to Prevent Post-Stroke Major Depression.
- ClinicalTrials.gov ID
- NCT00177424
- Acronym / sponsor ID
- K23MH067710-02
- Conditions
- Cerebrovascular Accident, Depression
- Keywords
- Rehabilitation
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Recruitment goals could not be met.
- Enrolment
- 154 participants (estimated)
- Lead sponsor
- University of PittsburghUniversity, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Study start
- Jul 2004
- Primary completion
- Oct 2007 (actual)
- Study completion
- Oct 2007 (actual)
- First posted
- 15 Sep 2005 (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.
This study will determine the effectiveness of sertraline administration after a stroke in preventing the onset of post-stroke depression.
Detailed description
Persons who suffer from a stroke are at high risk for developing post-stroke major depression (PSMD), an illness that has a negative impact on post-stroke physical rehabilitation and is associated with increased morbidity and mortality. Unfortunately, early detection and successful treatment of post-stroke major depression improves, but does not normalize, stroke rehabilitation outcomes compared to stroke survivors who never developed post-stroke depression. Therefore, preventing the onset of PSMD and its associated disability is an attractive possibility. This study is a placebo controlled, 10-month double-blind trial of sertraline in the prevention of PSMD in stroke survivors, with a 2-month naturalistic continuation phase. The primary outcome will be the incidence of Major Depression post-stroke. Additional outcomes will include the severity of depressive symptoms post-stroke and the level of disability experienced by the two treatment groups. An exploratory analysis will also be conducted to elucidate participant characteristics that may be moderators of the participants' response to the preventive intervention, thereby refining the profile of disabled stroke survivors most likely to benefit from the preventive intervention.
For information on a related study, please follow this link:
http://clinicaltrials.gov/show/NCT00781326
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Drug: sertralineSertraline |
| 2 | Placebo comparator | Drug: Placebomatching placebo |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Ischemic stroke within 3 months of study entry
- Admitted to a UPMC hospital for acute inpatient treatment or rehabilitation of stroke
- Speaks English
- Females willing to use an effective form of birth control throughout the study
Key exclusion criteria (14 listed)
- Meets DSM-IV-TR criteria for a major depressive episode
- History of any bipolar disorder
- Psychotic or history of a psychotic disorder
- Meets DMS-IV TR criteria for alcohol or substance abuse or dependence criteria within 3 months of study entry
- Current treatment with antidepressant medication for any reason (e.g., anxiety disorder, neuropathic pain)
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 |
|---|---|---|
| sertralineSubjects will initially be started on either sertraline 12.5mg/d or placebo and will receive this dose for 3 days. Subjects will then be increased to 25mg/d for 4 days, then 50mg/d for 7 days, then increased to 75mg/d. Seventy-five mg per day is the target dose for the remainder of the subject's participation in the study. The study medication will not be titrated past 75mg/d. | Drug | 1 |
| Placebomatching placebo tablets | Drug | 2 |
Primary outcome
The primary outcome will be the incidence of Major Depression post-stroke.
Time frame: 12 months
1 secondary outcome
Additional outcomes will include the severity of depressive symptoms post-stroke as measured by the Hamilton Depression Rating Scale, and the level of disability experienced by the two treatment groups, as measured by the Functional Independence Measure.
Time frame: 12 months
Results and safety
The study was stopped early (reason given: Recruitment goals could not be met.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jun 2014.
- The American Stroke Association website provides general information to stroke survivors and their families.Link provided by the sponsor.
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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.
Ellen M Whyte, MD principal investigator
University of Pittsburgh
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing sertraline in people with Cerebrovascular Accident and Depression, run by University of Pittsburgh 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 4 inclusion and 14 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: stopped early, as of the sponsor's last update on 27 Jun 2014. 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. Some participants in this study may receive a placebo. 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?
The study was stopped early (reason given: Recruitment goals could not be met.). Results are not available in the source record.
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?
The primary outcome will be the incidence of Major Depression post-stroke. (time frame: 12 months). It is what the study was designed to measure, not a finding.
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 27 Jun 2014.