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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00254020
Recruitment Status : Completed
First Posted : November 15, 2005
Last Update Posted : April 28, 2017
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Depression Drug: Citalopram Phase 4

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 138 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: The Role of Cytokine-Serotonin Interactions in Post-Stroke Depression
Study Start Date : June 2005
Actual Primary Completion Date : January 2011
Actual Study Completion Date : December 2013

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Intervention Details:
    Drug: Citalopram
    Patients who are found to have major depression will be referred to a psychologist
    Other Name: Celexa

Primary Outcome Measures :
  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 Outcome Measures :
  1. Modified Rankin Scale (mRS) [ Time Frame: Baseline, 6 weeks, 12 weeks ]
  2. NIH Stroke Scale [ Time Frame: Baseline, 6 weeks, 12 weeks ]

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00254020

Canada, Ontario
York Central Hospital
Richmond Hill, Ontario, Canada, L4C 4Z3
St. John's Rehabilitation Hospital
Toronto, Ontario, Canada, M2M 2G1
Toronto Rehabilitation Institute
Toronto, Ontario, Canada, M4G 1R7
Sunnybrook Health Sciences Centre
Toronto, Ontario, Canada, M4N 3M5
Toronto, Ontario, Canada, M6A 2E1
Sponsors and Collaborators
Sunnybrook Health Sciences Centre
Principal Investigator: Krista L Lanctot, PhD Sunnybrook Health Sciences Centre

Publications of Results:
Responsible Party: Sunnybrook Health Sciences Centre Identifier: NCT00254020     History of Changes
Other Study ID Numbers: 380-2004
First Posted: November 15, 2005    Key Record Dates
Last Update Posted: April 28, 2017
Last Verified: April 2017

Keywords provided by Sunnybrook Health Sciences Centre:

Additional relevant MeSH terms:
Depressive Disorder
Behavioral Symptoms
Mood Disorders
Mental Disorders
Serotonin Receptor Agonists
Serotonin Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Serotonin Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Antidepressive Agents, Second-Generation
Antidepressive Agents
Psychotropic Drugs
Antiparkinson Agents
Anti-Dyskinesia Agents
Autonomic Agents
Peripheral Nervous System Agents
Muscarinic Antagonists
Cholinergic Antagonists
Cholinergic Agents