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| Descriptive Information Fields | |||||
| Brief Title † | Sertraline for Preventing Post-Stroke Depression and Improving Rehabilitation Outcomes | ||||
| Official Title † | Intervention to Prevent Post-Stroke Major Depression. | ||||
| Brief Summary | This study will determine the effectiveness of sertraline administration after a stroke in preventing the onset of post-stroke depression. |
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| 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. |
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| Study Phase | Phase IV | ||||
| Study Type † | Interventional | ||||
| Study Design † | Prevention, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Efficacy Study | ||||
| Primary Outcome Measure † | The primary outcome will be the incidence of Major Depression post-stroke. | ||||
| Secondary Outcome Measure † | 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. | ||||
| Condition † | Cerebrovascular Accident Depression |
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| Intervention † | Drug: sertraline | ||||
| MEDLINE PMIDs | |||||
| Links | The American Stroke Association website provides general information to stroke survivors and their families. ![]() |
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| Recruitment Information Fields | |||||
| Recruitment Status † | Recruiting | ||||
| Enrollment † | 154 | ||||
| Start Date † | July 2004 | ||||
| Completion Date | December 2009 | ||||
| Eligibility Criteria † | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||
| Ages | 40 Years and older | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts †† |
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| Location Countries † | United States | ||||
| Administrative Information Fields | |||||
| NCT ID † | NCT00177424 | ||||
| Organization ID | K23 MH67710 | ||||
| Secondary IDs †† | 0310068, DATR AK-TNGP1 | ||||
| Study Sponsor † | National Institute of Mental Health (NIMH) | ||||
| Collaborators †† | |||||
| Investigators † |
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| Information Provided By | National Institute of Mental Health (NIMH) | ||||
| Verification Date | June 2006 | ||||
| First Received Date † | September 12, 2005 | ||||
| Last Updated Date | September 27, 2007 | ||||