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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Sunnybrook Health Sciences Centre
ClinicalTrials.gov Identifier:
NCT00254020
First received: November 10, 2005
Last updated: April 17, 2014
Last verified: April 2014
  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: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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:
  • Hamilton Depression Rating Scale (HAM-D) [ Time Frame: Baseline, 6 weeks, 12 weeks ] [ Designated as safety issue: No ]
  • Mini Mental State Examination (MMSE) [ Time Frame: Baseline, 6 weeks, 12 weeks ] [ Designated as safety issue: No ]
  • NINCDS-CSN Vascular Cognitive Impairment Battery [ Time Frame: Baseline, 6 weeks, 12 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Centre for Epidemiological Studies-Depression Scale (CES-D) [ Time Frame: Baseline, 6 weeks, 12 weeks ] [ Designated as safety issue: No ]
  • Modified Rankin Scale (mRS) [ Time Frame: Baseline, 6 weeks, 12 weeks ] [ Designated as safety issue: No ]
  • NIH Stroke Scale [ Time Frame: Baseline, 6 weeks, 12 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment: 100
Study Start Date: June 2005
Estimated Study Completion Date: December 2014
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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00254020

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

No publications provided

Responsible Party: Sunnybrook Health Sciences Centre
ClinicalTrials.gov Identifier: NCT00254020     History of Changes
Other Study ID Numbers: 380-2004
Study First Received: November 10, 2005
Last Updated: April 17, 2014
Health Authority: Canada: Health Canada

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
Citalopram
Dexetimide
Serotonin
Serotonin Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Serotonin Agents
Physiological Effects of Drugs
Antidepressive Agents, Second-Generation
Antidepressive Agents
Psychotropic Drugs
Central Nervous System Agents
Therapeutic Uses
Antiparkinson Agents
Anti-Dyskinesia Agents
Parasympatholytics
Autonomic Agents
Peripheral Nervous System Agents
Muscarinic Antagonists
Cholinergic Antagonists
Cholinergic Agents
Serotonin Receptor Agonists

ClinicalTrials.gov processed this record on September 16, 2014