Preventing Post-Stroke Depression
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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
| ClinicalTrials.gov Identifier: NCT00071643 |
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Recruitment Status :
Completed
First Posted : October 30, 2003
Last Update Posted : September 5, 2017
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| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Depression Cerebrovascular Accident | Behavioral: Problem Solving Therapy Drug: Escitalopram Other: Placebo | Not Applicable |
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.
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 201 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | Triple (Participant, Care Provider, Outcomes Assessor) |
| Primary Purpose: | Prevention |
| Official Title: | Prevention of Post-Stroke Depression - Treatment Strategy |
| Study Start Date : | September 2002 |
| Actual Primary Completion Date : | November 2008 |
| Actual Study Completion Date : | November 2008 |
| Arm | Intervention/treatment |
|---|---|
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Experimental: 1 Problem Solving Therapy
Participants will receive problem solving therapy.
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Behavioral: Problem Solving Therapy
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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Experimental: 2. Escitalopram
Participants will receive escitalopram.
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Drug: Escitalopram
Participants will receive escitalopram, a selective serotonin reuptake inhibitor.
Other Name: Lexapro |
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Placebo Comparator: 3 Placebo
Participants will receive placebo.
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Other: Placebo
Participants will receive a placebo pill. |
- Incidence of depressive disorders in the study population [ Time Frame: Measured at baseline, Week 6, and Months 3, 6, 9, 12, and 18 ]
- Functional Independence Measure [ Time Frame: Measured at baseline, at Week 6, and at Months 3, 6, 9, 12, and 18 ]
- Stroke Impact Scale [ Time Frame: Measured at baseline, Week 6, and Months 3, 6, 9, 12, and 18 ]
- Neurocognitive tests of executive functions and speed of information processing [ Time Frame: Measured at baseline and after 12 months ]
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
| Ages Eligible for Study: | 31 Years to 89 Years (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Stroke within the last 120 days
Exclusion Criteria:
- DSM (Diagnostic and Statistical Manual) IV criteria for major or minor depressive disorder
- Heart, respiratory, kidney, or liver failure; severely disabling musculoskeletal disorder; or cancer
- Diagnosis of neurodegenerative disorders such as Parkinson's disease, Alzheimer's disease, Multiple System Atrophy, or Huntington's disease
- Pre-existing dementia or aphasia with severe language comprehension deficits
- Alcohol or substance abuse or dependence within the last 12 months
- Recurrent unipolar or bipolar disorder prior to the stroke
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00071643
| United States, Illinois | |
| University of Chicago | |
| Chicago, Illinois, United States, 60637 | |
| United States, Iowa | |
| University of Iowa Hospitals and Clinics | |
| Iowa City, Iowa, United States, 52242-1000 | |
| United States, New York | |
| Burke Rehabilitation Hospital | |
| White Plains, New York, United States, 10605 | |
| Responsible Party: | Robert G. Robinson, Professor, University of Iowa |
| ClinicalTrials.gov Identifier: | NCT00071643 |
| Other Study ID Numbers: |
200207091 R01MH065134 ( U.S. NIH Grant/Contract ) DATR A4-GPX |
| First Posted: | October 30, 2003 Key Record Dates |
| Last Update Posted: | September 5, 2017 |
| Last Verified: | August 2017 |
| Studies a U.S. FDA-regulated Drug Product: | No |
| Studies a U.S. FDA-regulated Device Product: | No |
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Stroke |
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Stroke Depression Depressive Disorder Cerebrovascular Disorders Brain Diseases Central Nervous System Diseases Nervous System Diseases Vascular Diseases Cardiovascular Diseases Behavioral Symptoms Mood Disorders Mental Disorders |
Citalopram Serotonin Uptake Inhibitors Neurotransmitter Uptake Inhibitors Membrane Transport Modulators Molecular Mechanisms of Pharmacological Action Neurotransmitter Agents Serotonin Agents Physiological Effects of Drugs Antidepressive Agents, Second-Generation Antidepressive Agents Psychotropic Drugs |