Sertraline for Preventing Post-stroke Depression and Improving Rehabilitation Outcomes

Sponsor

University of Pittsburgh (Other)

Overall Status

Terminated

CT.gov ID

NCT00177424

Collaborator

National Institute of Mental Health (NIMH) (NIH)

154

Enrollment

Location

Arms

Duration (Months)

3.9

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Cerebrovascular Accident Depression	Drug: sertraline Drug: Placebo	Phase 4

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

Study Design

Study Type:

Interventional

Anticipated Enrollment :

154 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Primary Purpose:

Prevention

Official Title:

Intervention to Prevent Post-Stroke Major Depression.

Study Start Date :

Jul 1, 2004

Actual Primary Completion Date :

Oct 1, 2007

Actual Study Completion Date :

Oct 1, 2007

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: 1 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.
Placebo Comparator: 2 matching placebo	Drug: Placebo matching placebo tablets

Arm

Intervention/Treatment

Active Comparator: 1

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.

Placebo Comparator: 2

matching placebo

Drug: Placebo

matching placebo tablets

Outcome Measures

Primary Outcome Measures

The primary outcome will be the incidence of Major Depression post-stroke. [12 months]

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. [12 months]

Eligibility Criteria

Criteria

Ages Eligible for Study:

40 Years and Older

Sexes Eligible for Study:

All

Accepts 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