NCT00177424

Brief Summary

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

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
154

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started Jul 2004

Typical duration for phase_4

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2004

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

September 12, 2005

Completed
3 days until next milestone

First Posted

Study publicly available on registry

September 15, 2005

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2007

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2007

Completed
Last Updated

June 27, 2014

Status Verified

February 1, 2009

Enrollment Period

3.3 years

First QC Date

September 12, 2005

Last Update Submit

June 26, 2014

Conditions

Cerebrovascular AccidentDepression

Keywords

Rehabilitation

Outcome Measures

Primary Outcomes (1)

  • The primary outcome will be the incidence of Major Depression post-stroke.

    12 months

Secondary Outcomes (1)

  • 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

Study Arms (2)

1

ACTIVE COMPARATOR

Sertraline

Drug: sertraline

2

PLACEBO COMPARATOR

matching placebo

Drug: Placebo

Interventions

sertralineDRUG

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.

1
PlaceboDRUG

matching placebo tablets

2

Eligibility Criteria

Age40 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Pittsburgh Medical Center

Pittsburgh, Pennsylvania, 15213, United States

Location

Related Links

MeSH Terms

Conditions

StrokeDepression

Interventions

Sertraline

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular DiseasesBehavioral SymptomsBehavior

Intervention Hierarchy (Ancestors)

1-NaphthylamineAminesOrganic ChemicalsNaphthalenesPolycyclic Aromatic HydrocarbonsHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsPolycyclic Compounds

Study Officials

  • Ellen M Whyte, MD

    University of Pittsburgh

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 12, 2005

First Posted

September 15, 2005

Study Start

July 1, 2004

Primary Completion

October 1, 2007

Study Completion

October 1, 2007

Last Updated

June 27, 2014

Record last verified: 2009-02

Locations

US(1)