Sertraline for Preventing Post-Stroke Depression and Improving Rehabilitation Outcomes - Full Text View

Sponsor:	National Institute of Mental Health (NIMH)
Information provided by:	National Institute of Mental Health (NIMH)
ClinicalTrials.gov Identifier:	NCT00177424

Purpose

This study will determine the effectiveness of sertraline administration after a stroke in preventing the onset of post-stroke depression.

Condition	Intervention	Phase
Cerebrovascular Accident Depression	Drug: sertraline Drug: Placebo	Phase IV

Study Type:	Interventional
Study Design:	Prevention, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Efficacy Study
Official Title:	Intervention to Prevent Post-Stroke Major Depression.

Resource links provided by NLM:

MedlinePlus related topics: Depression Rehabilitation

Drug Information available for: Sertraline hydrochloride Sertraline

U.S. FDA Resources

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

Primary Outcome Measures:

The primary outcome will be the incidence of Major Depression post-stroke. [ Time Frame: 12 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

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. [ Time Frame: 12 months ] [ Designated as safety issue: No ]

Estimated Enrollment:	154
Study Start Date:	July 2004
Study Completion Date:	October 2007
Primary Completion Date:	October 2007 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Active Comparator Sertraline	Drug: sertraline Subjects will initially be started on either sertraline 12.5mg/d or placebo and will receive this dose for 3 days. Subjects will then be increased to 25mg/d for 4 days, then 50mg/d for 7 days, then increased to 75mg/d. Seventy-five mg per day is the target dose for the remainder of the subject's participation in the study. The study medication will not be titrated past 75mg/d.
2: Placebo Comparator matching placebo	Drug: Placebo matching placebo tablets

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.

For information on a related study, please follow this link:

http://clinicaltrials.gov/show/NCT00781326

Eligibility

Ages Eligible for Study:	40 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Ischemic stroke within 3 months of study entry
Admitted to a UPMC hospital for acute inpatient treatment or rehabilitation of stroke
Speaks English
Females willing to use an effective form of birth control throughout the study

Exclusion Criteria:

Meets DSM-IV-TR criteria for a major depressive episode
History of any bipolar disorder
Psychotic or history of a psychotic disorder
Meets DMS-IV TR criteria for alcohol or substance abuse or dependence criteria within 3 months of study entry
Current treatment with antidepressant medication for any reason (e.g., anxiety disorder, neuropathic pain)
Primary hemorrhagic stroke
Language impairment severe enough to prevent valid neuropsychiatric assessment
History of another CNS disease other than prior stroke or psychiatric illness (e.g., head trauma, multiple sclerosis, HIV with CNS involvement)
Pulse <50 or >100 beats per minute
Significant hyponatremia (Na <130meq)
Current hypothyroid state
Medically unstable including symptoms of delirium (determined by review of the subject's medical status with the treating (clinical) physician; standard blood chemistry lab work will be obtained if not checked within the preceding 30 days)
History of sensitivity to sertraline
Pregnant or breastfeeding

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00177424

Locations

United States, Pennsylvania
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, United States, 15213

Sponsors and Collaborators

National Institute of Mental Health (NIMH)

Investigators

Principal Investigator:

Ellen M Whyte, MD

University of Pittsburgh

More Information

Additional Information:

The American Stroke Association website provides general information to stroke survivors and their families. This link exits the ClinicalTrials.gov site

This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	University of Pittsburgh ( Ellen Whyte, MD )
Study ID Numbers:	K23 MH067710-02, 0310068, DATR AK-TNGP1
Study First Received:	September 12, 2005
Last Updated:	February 19, 2009
ClinicalTrials.gov Identifier:	NCT00177424 History of Changes
Health Authority:	United States: Federal Government

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

Rehabilitation

Additional relevant MeSH terms:

Neurotransmitter Uptake Inhibitors
Neurotransmitter Agents
Cerebral Infarction
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Psychotropic Drugs
Brain Diseases
Cerebrovascular Disorders
Mental Disorders
Therapeutic Uses
Brain Ischemia
Sertraline
Cardiovascular Diseases
Antidepressive Agents

Depression
Nervous System Diseases
Stroke
Vascular Diseases
Central Nervous System Diseases
Depressive Disorder
Serotonin Uptake Inhibitors
Pharmacologic Actions
Behavioral Symptoms
Serotonin Agents
Mood Disorders
Brain Infarction
Central Nervous System Agents

ClinicalTrials.gov processed this record on November 03, 2009