Clinical trial NCT00254020: 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
Overall status: COMPLETED
Phase: PHASE4
Conditions: Depression
Keywords: stroke
depression
cytokines
serotonin
citalopram
Lead sponsor: Sunnybrook Health Sciences Centre
Sponsor class: OTHER
First posted: 2005-11-15
Enrollment: 138
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Centre for Epidemiological Studies-Depression Scale (CES-D)
timeFrame: Baseline, 6 weeks, 12 weeks
measure: Mini Mental State Examination (MMSE)
timeFrame: Baseline, 6 weeks, 12 weeks
measure: NINCDS-CSN Vascular Cognitive Impairment Battery
timeFrame: Baseline, 6 weeks, 12 weeks
Secondary outcomes:
measure: Modified Rankin Scale (mRS)
timeFrame: Baseline, 6 weeks, 12 weeks
measure: NIH Stroke Scale
timeFrame: Baseline, 6 weeks, 12 weeks
Other outcomes:
Locations:
city: Richmond Hill
country: Canada
facility: York Central Hospital
state: Ontario
city: Toronto
country: Canada
facility: St. John's Rehabilitation Hospital
state: Ontario
city: Toronto
country: Canada
facility: Toronto Rehabilitation Institute
state: Ontario
city: Toronto
country: Canada
facility: Sunnybrook Health Sciences Centre
state: Ontario
city: Toronto
country: Canada
facility: Baycrest
state: Ontario
Study officials:
affiliation: Sunnybrook Health Sciences Centre
name: Krista L Lanctot, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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.