Preventing Post-Stroke Depression - Full Text View

Sponsor:	National Institute of Mental Health (NIMH)
Information provided by:	National Institute of Mental Health (NIMH)
ClinicalTrials.gov Identifier:	NCT00071643

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 III

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:

MedlinePlus related topics: Depression

Drug Information available for: Serotonin Benzetimide Dexetimide Citalopram hydrobromide Citalopram Escitalopram Escitalopram oxalate

U.S. FDA Resources

Further study details as provided by National Institute of Mental Health (NIMH):

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
Estimated 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 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

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

National Institute of Mental Health (NIMH)

More Information

No publications provided by National Institute of Mental Health (NIMH)

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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. Epub 2011 Aug 25.

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.

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.

Responsible Party:	Robert G. Robinson, MD, University of Iowa
ClinicalTrials.gov Identifier:	NCT00071643 History of Changes
Other Study ID Numbers:	R01 MH65134, DATR A4-GPX
Study First Received:	October 29, 2003
Last Updated:	August 20, 2008
Health Authority:	United States: Federal Government

Keywords provided by National Institute of Mental Health (NIMH):

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 February 12, 2012