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

Depression Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00254020
• Other study ID #: 380-2004
• Status: Completed
• Phase: Phase 4
• First received: November 10, 2005
• Last updated: April 26, 2017
• Start date: June 2005
• Est. completion date: December 2013

Study information

• Verified date: April 2017
• Source: Sunnybrook Health Sciences Centre
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 138
• Est. completion date: December 2013
• Est. primary completion date: January 2011
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Depression
• Depressive Disorder

Intervention

Drug:
• Citalopram
Patients who are found to have major depression will be referred to a psychologist

Locations

Country	Name	City	State
Canada	York Central Hospital	Richmond Hill	Ontario
Canada	Baycrest	Toronto	Ontario
Canada	St. John's Rehabilitation Hospital	Toronto	Ontario
Canada	Sunnybrook Health Sciences Centre	Toronto	Ontario
Canada	Toronto Rehabilitation Institute	Toronto	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
Sunnybrook Health Sciences Centre

Country where clinical trial is conducted

Canada, 

References & Publications (1)

Bensimon K, Herrmann N, Swardfager W, Yi H, Black SE, Gao FQ, Snaiderman A, Lanctôt 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Centre for Epidemiological Studies-Depression Scale (CES-D)		Baseline, 6 weeks, 12 weeks
Primary	Mini Mental State Examination (MMSE)		Baseline, 6 weeks, 12 weeks
Primary	NINCDS-CSN Vascular Cognitive Impairment Battery		Baseline, 6 weeks, 12 weeks
Secondary	Modified Rankin Scale (mRS)		Baseline, 6 weeks, 12 weeks
Secondary	NIH Stroke Scale		Baseline, 6 weeks, 12 weeks