NCT00254020

Brief Summary

Depression is a common and often serious problem occurring in stroke patients. Inflammatory hormones, known as cytokines, are stimulated by an activated immune system and sometimes become active following a stroke. They may be responsible for altering levels of key neurotransmitters and their metabolites in the blood and brain of stroke patients. The investigators' objective is to examine whether increased cytokine activity following a stroke may be the cause of an increased presence or severity of depression or cognitive impairment among stroke patients, as a result of tryptophan depletion and/or kynurenine activation. They are recruiting patients within one month of their strokes and measuring levels of key markers in their blood. Patients are assessed for the presence of depressive and/or cognitive symptoms and treated with an antidepressant if needed. The investigators expect to show that cytokine activation is related to depression and/or cognitive impairment among stroke patients.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
138

participants targeted

Target at P50-P75 for phase_4 depression

Timeline
Completed

Started Jun 2005

Longer than P75 for phase_4 depression

Geographic Reach
1 country

5 active sites

Status
completed

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

June 1, 2005

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

November 10, 2005

Completed
5 days until next milestone

First Posted

Study publicly available on registry

November 15, 2005

Completed
5.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2011

Completed
2.9 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2013

Completed
Last Updated

April 28, 2017

Status Verified

April 1, 2017

Enrollment Period

5.6 years

First QC Date

November 10, 2005

Last Update Submit

April 26, 2017

Conditions

Depression

Keywords

strokedepressioncytokinesserotonincitalopram

Outcome Measures

Primary Outcomes (3)

  • Centre for Epidemiological Studies-Depression Scale (CES-D)

    Baseline, 6 weeks, 12 weeks

  • Mini Mental State Examination (MMSE)

    Baseline, 6 weeks, 12 weeks

  • NINCDS-CSN Vascular Cognitive Impairment Battery

    Baseline, 6 weeks, 12 weeks

Secondary Outcomes (2)

  • Modified Rankin Scale (mRS)

    Baseline, 6 weeks, 12 weeks

  • NIH Stroke Scale

    Baseline, 6 weeks, 12 weeks

Interventions

CitalopramDRUG

Patients who are found to have major depression will be referred to a psychologist

Also known as: Celexa

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age \> 18 years
  • Gender: male or female
  • Language: speaks and understands English
  • Clinical diagnosis of stroke according to World Health Organization MONICA Project and recent (\< 3 months) cerebral infarctions
  • Written, informed consent
  • Depressed group only: diagnosis of a major depressive episode according to the depression module of the Structured Clinical Interview for the DSM-IV (SCID-IV)

You may not qualify if:

  • Subarachnoid hemorrhage
  • Intracranial hemorrhage
  • Significant acute medical illness including: drug overdose, severely disturbed liver, kidney or lung function, anemia, hypothyroidism, or uncontrolled diabetes
  • Significant acute neurologic illness including: impaired consciousness, Parkinson's disease, Huntington's chorea, progressive supranuclear paralysis, brain tumor, subdural hematoma, multiple sclerosis, hydrocephalus, Binswanger's disease, or severe aphasia
  • Presence of a premorbid Axis I psychiatric diagnosis (eg. schizophrenia, bipolar disorder)
  • Depressed group only: contraindications to receiving treatment with citalopram (including previous nonresponse) or serious risk of suicide

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (5)

York Central Hospital

Richmond Hill, Ontario, L4C 4Z3, Canada

Location

St. John's Rehabilitation Hospital

Toronto, Ontario, M2M 2G1, Canada

Location

Toronto Rehabilitation Institute

Toronto, Ontario, M4G 1R7, Canada

Location

Sunnybrook Health Sciences Centre

Toronto, Ontario, M4N 3M5, Canada

Location

Baycrest

Toronto, Ontario, M6A 2E1, Canada

Location

Related Publications (1)

  • Bensimon K, Herrmann N, Swardfager W, Yi H, Black SE, Gao FQ, Snaiderman A, Lanctot KL. Kynurenine and depressive symptoms in a poststroke population. Neuropsychiatr Dis Treat. 2014 Sep 22;10:1827-35. doi: 10.2147/NDT.S65740. eCollection 2014.

    PMID: 25285006RESULT

MeSH Terms

Conditions

DepressionStroke

Interventions

Citalopram

Condition Hierarchy (Ancestors)

Behavioral SymptomsBehaviorCerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

PropylaminesAminesOrganic ChemicalsNitrilesBenzofuransHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic Compounds

Study Officials

  • Krista L Lanctot, PhD

    Sunnybrook Health Sciences Centre

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 10, 2005

First Posted

November 15, 2005

Study Start

June 1, 2005

Primary Completion

January 1, 2011

Study Completion

December 1, 2013

Last Updated

April 28, 2017

Record last verified: 2017-04

Locations

CA(5)