Sertraline for Preventing Post-stroke Depression and Improving Rehabilitation Outcomes

This study has been terminated.
(Recruitment goals could not be met.)
Sponsor:
Collaborator:
Information provided by (Responsible Party):
University of Pittsburgh
ClinicalTrials.gov Identifier:
NCT00177424
First received: September 12, 2005
Last updated: June 26, 2014
Last verified: February 2009
  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 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Intervention to Prevent Post-Stroke Major Depression.

Resource links provided by NLM:


Further study details as provided by University of Pittsburgh:

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
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

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
University of Pittsburgh
Investigators
Principal Investigator: Ellen M Whyte, MD University of Pittsburgh
  More Information

Additional Information:
No publications provided

Responsible Party: University of Pittsburgh
ClinicalTrials.gov Identifier: NCT00177424     History of Changes
Other Study ID Numbers: K23 MH067710-02, K23MH067710-02, 0310068, DATR AK-TNGP1
Study First Received: September 12, 2005
Last Updated: June 26, 2014
Health Authority: United States: Federal Government

Keywords provided by University of Pittsburgh:
Rehabilitation

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
Sertraline
Antidepressive Agents
Psychotropic Drugs
Central Nervous System Agents
Therapeutic Uses
Pharmacologic Actions
Serotonin Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Serotonin Agents
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on August 28, 2014