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

NCT ID: NCT00254020

Last Updated: 2017-04-28

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 138 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2005-06-30
• Study Completion Date: 2013-12-31

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.

Conditions

Depression

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Interventions

Citalopram

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

Intervention Type: DRUG

Other Intervention Names

Celexa

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Sunnybrook Health Sciences Centre

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Krista L Lanctot, PhD

Role: PRINCIPAL_INVESTIGATOR

Sunnybrook Health Sciences Centre

Locations

York Central Hospital

Richmond Hill, Ontario, Canada

St. John's Rehabilitation Hospital

Toronto, Ontario, Canada

Toronto Rehabilitation Institute

Toronto, Ontario, Canada

Sunnybrook Health Sciences Centre

Toronto, Ontario, Canada

Baycrest

Toronto, Ontario, Canada

Countries

Canada

References

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.

Reference Type: RESULT

PMID: 25285006 (View on PubMed)

Other Identifiers

380-2004

Identifier Type: -

Identifier Source: org_study_id