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

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

Status
Completed
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00254020
Enrollment
138
Registered
2005-11-15
Start date
2005-06-30
Completion date
2013-12-31
Last updated
2017-04-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Depression

Keywords

stroke, depression, cytokines, serotonin, citalopram

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.

Interventions

DRUGCitalopram

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

Sponsors

Sunnybrook Health Sciences Centre
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
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

Design outcomes

Primary

MeasureTime frame
Centre for Epidemiological Studies-Depression Scale (CES-D)Baseline, 6 weeks, 12 weeks
Mini Mental State Examination (MMSE)Baseline, 6 weeks, 12 weeks
NINCDS-CSN Vascular Cognitive Impairment BatteryBaseline, 6 weeks, 12 weeks

Secondary

MeasureTime frame
Modified Rankin Scale (mRS)Baseline, 6 weeks, 12 weeks
NIH Stroke ScaleBaseline, 6 weeks, 12 weeks

Countries

Canada

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 19, 2026