Preventing Post-Stroke Depression

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Robert G. Robinson, University of Iowa
ClinicalTrials.gov Identifier:
NCT00071643
First received: October 29, 2003
Last updated: July 1, 2013
Last verified: July 2013
  Purpose

This study will evaluate the effectiveness of both drug and non-drug treatments in preventing depression after a stroke.


Condition Intervention Phase
Depression
Cerebrovascular Accident
Behavioral: Problem Solving Therapy
Drug: Escitalopram
Other: Placebo
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Prevention of Post-Stroke Depression - Treatment Strategy

Resource links provided by NLM:


Further study details as provided by University of Iowa:

Primary Outcome Measures:
  • Incidence of depressive disorders in the study population [ Time Frame: Measured at baseline, Week 6, and Months 3, 6, 9, 12, and 18 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Functional Independence Measure [ Time Frame: Measured at baseline, at Week 6, and at Months 3, 6, 9, 12, and 18 ] [ Designated as safety issue: No ]
  • Stroke Impact Scale [ Time Frame: Measured at baseline, Week 6, and Months 3, 6, 9, 12, and 18 ] [ Designated as safety issue: No ]
  • Neurocognitive tests of executive functions and speed of information processing [ Time Frame: Measured at baseline and after 12 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 201
Study Start Date: September 2002
Primary Completion Date: November 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 Problem Solving Therapy
Participants will receive problem solving therapy.
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.
Experimental: 2. Escitalopram
Participants will receive escitalopram.
Drug: Escitalopram
Participants will receive escitalopram, a selective serotonin reuptake inhibitor.
Other Name: Lexapro
Placebo Comparator: 3 Placebo
Participants will receive placebo.
Other: Placebo
Participants will receive a placebo pill.

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   31 Years to 89 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00071643

Locations
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
Sponsors and Collaborators
University of Iowa
  More Information

No publications provided by University of Iowa

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Robert G. Robinson, Professor, University of Iowa
ClinicalTrials.gov Identifier: NCT00071643     History of Changes
Other Study ID Numbers: R01 MH65134, R01MH065134, DATR A4-GPX
Study First Received: October 29, 2003
Last Updated: July 1, 2013
Health Authority: United States: Federal Government

Keywords provided by University of Iowa:
Stroke

Additional relevant MeSH terms:
Depression
Depressive Disorder
Cerebral Infarction
Stroke
Behavioral Symptoms
Mood Disorders
Mental Disorders
Brain Infarction
Brain Ischemia
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Dexetimide
Citalopram
Serotonin Uptake Inhibitors
Antiparkinson Agents
Anti-Dyskinesia Agents
Central Nervous System Agents
Therapeutic Uses
Pharmacologic Actions
Parasympatholytics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Muscarinic Antagonists
Cholinergic Antagonists
Cholinergic Agents

ClinicalTrials.gov processed this record on August 28, 2014