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Completed

NCT Number: NCT00254020

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

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.

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Key information

Conditions

Depression Behavior Behavioral Symptoms Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Nervous System Diseases Stroke Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

York Central Hospital, Richmond Hill, Ontario, Canada

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Citalopram

Drug

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

Other names: Celexa

Primary outcomes

  1. Centre for Epidemiological Studies-Depression Scale (CES-D)

    Time frame: Baseline, 6 weeks, 12 weeks

  2. Mini Mental State Examination (MMSE)

    Time frame: Baseline, 6 weeks, 12 weeks

  3. NINCDS-CSN Vascular Cognitive Impairment Battery

    Time frame: Baseline, 6 weeks, 12 weeks

Secondary outcomes

  1. Modified Rankin Scale (mRS)

    Time frame: Baseline, 6 weeks, 12 weeks

  2. NIH Stroke Scale

    Time frame: Baseline, 6 weeks, 12 weeks

Sponsors and collaborators

Lead sponsor

Sunnybrook Health Sciences Centre

Other

Registry information

Important dates

Study start
2005
Primary completion
2011
Study completion
2013
First posted
Nov 15, 2005
Registry last updated
Apr 28, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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