Sertraline for Preventing Post-stroke Depression and Improving Rehabilitation Outcomes

University of Pittsburgh

Status and phase

Terminated

Phase 4

Conditions

Cerebrovascular Accident

Depression

Treatments

Drug: sertraline

Drug: Placebo

Study type

Interventional

Funder types

Other

NIH

Identifiers

NCT00177424

K23MH067710-02 (U.S. NIH Grant/Contract)

0310068

DATR AK-TNGP1

Details and patient eligibility

About

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

Full 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

Enrollment

154 estimated patients

Sex

All

Ages

40+ years old

Volunteers

No Healthy Volunteers

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