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

April 26, 2017 updated by: Sunnybrook Health Sciences Centre

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.

Study Overview

Status

Completed

Conditions

Depression

Intervention / Treatment

Drug: Citalopram

Study Type

Interventional

Enrollment (Actual)

138

Phase

Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Canada
- Ontario
  - Richmond Hill, Ontario, Canada, L4C 4Z3
    - York Central Hospital
  - Toronto, Ontario, Canada, M4N 3M5
    - Sunnybrook Health Sciences Centre
  - Toronto, Ontario, Canada, M6A 2E1
    - Baycrest
  - Toronto, Ontario, Canada, M2M 2G1
    - St. John's Rehabilitation Hospital
  - Toronto, Ontario, Canada, M4G 1R7
    - Toronto Rehabilitation Institute

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Primary Purpose: Treatment
Allocation: N/A
Interventional Model: Single Group Assignment
Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Centre for Epidemiological Studies-Depression Scale (CES-D) Time Frame: Baseline, 6 weeks, 12 weeks	Baseline, 6 weeks, 12 weeks
Mini Mental State Examination (MMSE) Time Frame: Baseline, 6 weeks, 12 weeks	Baseline, 6 weeks, 12 weeks
NINCDS-CSN Vascular Cognitive Impairment Battery Time Frame: Baseline, 6 weeks, 12 weeks	Baseline, 6 weeks, 12 weeks

Secondary Outcome Measures

Outcome Measure	Time Frame
Modified Rankin Scale (mRS) Time Frame: Baseline, 6 weeks, 12 weeks	Baseline, 6 weeks, 12 weeks
NIH Stroke Scale Time Frame: Baseline, 6 weeks, 12 weeks	Baseline, 6 weeks, 12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sunnybrook Health Sciences Centre

Investigators

Principal Investigator: Krista L Lanctôt, PhD, Sunnybrook Health Sciences Centre

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2005

Primary Completion (Actual)

January 1, 2011

Study Completion (Actual)

December 1, 2013

Study Registration Dates

First Submitted

November 10, 2005

First Submitted That Met QC Criteria