Sertraline for Preventing Post-stroke Depression and Improving Rehabilitation Outcomes

Depression Clinical Trial

Official title:

Intervention to Prevent Post-Stroke Major Depression.

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00177424
• Other study ID #: K23MH067710-02
• Secondary ID: K23MH067710-0203
• Status: Terminated
• Phase: Phase 4
• First received: September 12, 2005
• Last updated: June 26, 2014
• Start date: July 2004
• Est. completion date: October 2007

Study information

• Verified date: February 2009
• Source: University of Pittsburgh
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial Summary

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

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

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 154
• Est. completion date: October 2007
• Est. primary completion date: October 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 40 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Cerebrovascular Accident
• Depression
• Depressive Disorder
• Stroke

Intervention

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
matching placebo tablets

Locations

Country	Name	City	State
United States	University of Pittsburgh Medical Center	Pittsburgh	Pennsylvania

Sponsors (2)

Lead Sponsor	Collaborator
University of Pittsburgh	National Institute of Mental Health (NIMH)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The primary outcome will be the incidence of Major Depression post-stroke.		12 months	No
Secondary	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	No

External Links

•   The American Stroke Association website provides general information to stroke survivors and their families.