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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00254020
First Posted: November 15, 2005
Last Update Posted: April 28, 2017
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.
Information provided by (Responsible Party):
Sunnybrook Health Sciences Centre
  Purpose
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 Intervention Phase
Depression Drug: Citalopram Phase 4

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: The Role of Cytokine-Serotonin Interactions in Post-Stroke Depression

Resource links provided by NLM:


Further study details as provided by Sunnybrook Health Sciences Centre:

Primary Outcome Measures:
  • Centre for Epidemiological Studies-Depression Scale (CES-D) [ Time Frame: Baseline, 6 weeks, 12 weeks ]
  • Mini Mental State Examination (MMSE) [ Time Frame: Baseline, 6 weeks, 12 weeks ]
  • NINCDS-CSN Vascular Cognitive Impairment Battery [ Time Frame: Baseline, 6 weeks, 12 weeks ]

Secondary Outcome Measures:
  • Modified Rankin Scale (mRS) [ Time Frame: Baseline, 6 weeks, 12 weeks ]
  • NIH Stroke Scale [ Time Frame: Baseline, 6 weeks, 12 weeks ]

Enrollment: 138
Study Start Date: June 2005
Study Completion Date: December 2013
Primary Completion Date: January 2011 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: Citalopram
    Patients who are found to have major depression will be referred to a psychologist
    Other Name: Celexa
  Eligibility

Information from the National Library of Medicine

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

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
  Contacts and Locations
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 ClinicalTrials.gov identifier (NCT number): NCT00254020


Locations
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
Baycrest
Toronto, Ontario, Canada, M6A 2E1
Sponsors and Collaborators
Sunnybrook Health Sciences Centre
Investigators
Principal Investigator: Krista L Lanctot, PhD Sunnybrook Health Sciences Centre
  More Information

Publications:
Responsible Party: Sunnybrook Health Sciences Centre
ClinicalTrials.gov Identifier: NCT00254020     History of Changes
Other Study ID Numbers: 380-2004
First Submitted: November 10, 2005
First Posted: November 15, 2005
Last Update Posted: April 28, 2017
Last Verified: April 2017

Keywords provided by Sunnybrook Health Sciences Centre:
stroke
depression
cytokines
serotonin
citalopram

Additional relevant MeSH terms:
Depression
Depressive Disorder
Behavioral Symptoms
Mood Disorders
Mental Disorders
Serotonin
Citalopram
Dexetimide
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
Parasympatholytics
Autonomic Agents
Peripheral Nervous System Agents
Muscarinic Antagonists
Cholinergic Antagonists
Cholinergic Agents