Back to resultsThe Role of Cytokine-Serotonin Interactions in Post-Stroke Depression
Primary Purpose
Depression
Status
Completed
Phase
Phase 4
Locations
Canada
Study Type
Interventional
Intervention
Citalopram
Sponsored by
About this trial
This is an interventional treatment trial for Depression focused on measuring stroke, depression, cytokines, serotonin, citalopram
Eligibility 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
Sites / Locations
- York Central Hospital
- St. John's Rehabilitation Hospital
- Toronto Rehabilitation Institute
- Sunnybrook Health Sciences Centre
- Baycrest
Outcomes
Primary Outcome Measures
Centre for Epidemiological Studies-Depression Scale (CES-D)
Mini Mental State Examination (MMSE)
NINCDS-CSN Vascular Cognitive Impairment Battery
Secondary Outcome Measures
Modified Rankin Scale (mRS)
NIH Stroke Scale
Full Information
NCT ID
NCT00254020
First Posted
November 10, 2005
Last Updated
April 26, 2017
Sponsor
Sunnybrook Health Sciences Centre
1. Study Identification
Unique Protocol Identification Number
NCT00254020
Brief Title
The Role of Cytokine-Serotonin Interactions in Post-Stroke Depression
Official Title
The Role of Cytokine-Serotonin Interactions in Post-Stroke Depression
Study Type
Interventional
2. Study Status
Record Verification Date
April 2017
Overall Recruitment Status
Completed
Study Start Date
June 2005 (undefined)
Primary Completion Date
January 2011 (Actual)
Study Completion Date
December 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Sunnybrook Health Sciences Centre
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Depression
Keywords
stroke, depression, cytokines, serotonin, citalopram
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
138 (Actual)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
Citalopram
Other Intervention Name(s)
Celexa
Intervention Description
Patients who are found to have major depression will be referred to a psychologist
Primary Outcome Measure Information:
Title
Centre for Epidemiological Studies-Depression Scale (CES-D)
Time Frame
Baseline, 6 weeks, 12 weeks
Title
Mini Mental State Examination (MMSE)
Time Frame
Baseline, 6 weeks, 12 weeks
Title
NINCDS-CSN Vascular Cognitive Impairment Battery
Time Frame
Baseline, 6 weeks, 12 weeks
Secondary Outcome Measure Information:
Title
Modified Rankin Scale (mRS)
Time Frame
Baseline, 6 weeks, 12 weeks
Title
NIH Stroke Scale
Time Frame
Baseline, 6 weeks, 12 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Krista L Lanctot, PhD
Organizational Affiliation
Sunnybrook Health Sciences Centre
Official's Role
Principal Investigator
Facility Information:
Facility Name
York Central Hospital
City
Richmond Hill
State/Province
Ontario
ZIP/Postal Code
L4C 4Z3
Country
Canada
Facility Name
St. John's Rehabilitation Hospital
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M2M 2G1
Country
Canada
Facility Name
Toronto Rehabilitation Institute
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M4G 1R7
Country
Canada
Facility Name
Sunnybrook Health Sciences Centre
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M4N 3M5
Country
Canada
Facility Name
Baycrest
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M6A 2E1
Country
Canada
12. IPD Sharing Statement
Citations:
PubMed Identifier
25285006
Citation
Bensimon K, Herrmann N, Swardfager W, Yi H, Black SE, Gao FQ, Snaiderman A, Lanctot KL. Kynurenine and depressive symptoms in a poststroke population. Neuropsychiatr Dis Treat. 2014 Sep 22;10:1827-35. doi: 10.2147/NDT.S65740. eCollection 2014.
Results Reference
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The Role of Cytokine-Serotonin Interactions in Post-Stroke Depression
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