The Role of Cytokine-Serotonin Interactions in Post-Stroke Depression

Phase 4

Completed

• Conditions: Depression

• Registration Number: NCT00254020
• Lead Sponsor: Sunnybrook Health Sciences Centre

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2005-06
• Study First Submitted: 2005-11-10
• Study First Submitted QC: 2005-11-10
• Study First Posted: 2005-11-15
• Primary Completion: 2011-01
• Study Completion: 2013-12
• Status Verified: 2017-04
• Last Update Submitted: 2017-04-26
• Last Update Posted: 2017-04-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 138

Inclusion Criteria

• 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)

Exclusion Criteria

• 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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
NIH Stroke Scale	Baseline, 6 weeks, 12 weeks
Modified Rankin Scale (mRS)	Baseline, 6 weeks, 12 weeks

Trial Locations

Locations (5)

York Central Hospital; 🇨🇦 Richmond Hill, Ontario, Canada

Sunnybrook Health Sciences Centre; 🇨🇦 Toronto, Ontario, Canada

Baycrest; 🇨🇦 Toronto, Ontario, Canada

St. John's Rehabilitation Hospital; 🇨🇦 Toronto, Ontario, Canada

Toronto Rehabilitation Institute; 🇨🇦 Toronto, Ontario, Canada