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| ID | Type | Description | Link |
|---|---|---|---|
| R01MH065134 | U.S. NIH Grant/Contract | View source | |
| DATR A4-GPX |
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| Name | Class |
|---|---|
| National Institute of Mental Health (NIMH) | NIH |
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This study will evaluate the effectiveness of both drug and non-drug treatments in preventing depression after a stroke.
The development of depression after a stroke is a serious condition that can have negative effects on thought, emotions, and overall daily functioning, particularly in the first year following the stroke. Evidence suggests that antidepressants may be used to prevent post-stroke depression. This study will treat nondepressed stroke patients with antidepressants or problem solving therapy (PST) to determine the most effective treatments for preventing depression.
Participants in this study will be randomly assigned to receive PST, escitalopram, or placebo (an inactive pill) for 12 months. Participants who display depressive symptoms for 2 weeks or more will be removed from the study. After 12 months, treatment will be discontinued and participants will be monitored for an additional 6 months.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 Problem Solving Therapy | Experimental | Participants will receive problem solving therapy. |
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| 2. Escitalopram | Experimental | Participants will receive escitalopram. |
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| 3 Placebo | Placebo Comparator | Participants will receive placebo. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Problem Solving Therapy | Behavioral | Problem solving therapy aims to make patients aware of symptoms of problems and link those with behaviors associated with solving them. |
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| Measure | Description | Time Frame |
|---|---|---|
| Incidence of depressive disorders in the study population | Measured at baseline, Week 6, and Months 3, 6, 9, 12, and 18 |
| Measure | Description | Time Frame |
|---|---|---|
| Functional Independence Measure | Measured at baseline, at Week 6, and at Months 3, 6, 9, 12, and 18 | |
| Stroke Impact Scale | Measured at baseline, Week 6, and Months 3, 6, 9, 12, and 18 | |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Chicago | Chicago | Illinois | 60637 | United States | ||
| University of Iowa Hospitals and Clinics |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 21868736 | Derived | Mikami K, Jorge RE, Moser DJ, Arndt S, Jang M, Solodkin A, Small SL, Fonzetti P, Hegel MT, Robinson RG. Increased frequency of first-episode poststroke depression after discontinuation of escitalopram. Stroke. 2011 Nov;42(11):3281-3. doi: 10.1161/STROKEAHA.111.626507. Epub 2011 Aug 25. | |
| 20124118 | Derived | Jorge RE, Acion L, Moser D, Adams HP Jr, Robinson RG. Escitalopram and enhancement of cognitive recovery following stroke. Arch Gen Psychiatry. 2010 Feb;67(2):187-96. doi: 10.1001/archgenpsychiatry.2009.185. |
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| ID | Term |
|---|---|
| D003863 | Depression |
| D020521 | Stroke |
| ID | Term |
|---|---|
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
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| ID | Term |
|---|---|
| D000089983 | Escitalopram |
| ID | Term |
|---|---|
| D011437 | Propylamines |
| D000588 | Amines |
| D009930 | Organic Chemicals |
| D009570 | Nitriles |
| D001572 |
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| Escitalopram | Drug | Participants will receive escitalopram, a selective serotonin reuptake inhibitor. |
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| Placebo | Other | Participants will receive a placebo pill. |
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| Neurocognitive tests of executive functions and speed of information processing |
| Measured at baseline and after 12 months |
| Iowa City |
| Iowa |
| 52242-1000 |
| United States |
| Burke Rehabilitation Hospital | White Plains | New York | 10605 | United States |
| 18505948 | Derived | Robinson RG, Jorge RE, Moser DJ, Acion L, Solodkin A, Small SL, Fonzetti P, Hegel M, Arndt S. Escitalopram and problem-solving therapy for prevention of poststroke depression: a randomized controlled trial. JAMA. 2008 May 28;299(20):2391-400. doi: 10.1001/jama.299.20.2391. |
| D002493 |
| Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| Benzofurans |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |