The Role of Cytokine-Serotonin Interactions in Post-Stroke Depression - Full Text View

Sponsored by:	Sunnybrook Health Sciences Centre
Information provided by:	Sunnybrook Health Sciences Centre
ClinicalTrials.gov Identifier:	NCT00254020

Purpose

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.

Condition	Intervention	Phase
Depression	Drug: citalopram (celexa)	Phase IV

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Efficacy Study
Official Title:	The Role of Cytokine-Serotonin Interactions in Post-Stroke Depression

Resource links provided by NLM:

MedlinePlus related topics: Depression

Drug Information available for: Serotonin Benzetimide Dexetimide Citalopram hydrobromide Citalopram Escitalopram Escitalopram oxalate

U.S. FDA Resources

Further study details as provided by Sunnybrook Health Sciences Centre:

Primary Outcome Measures:

Hamilton Depression Rating Scale (HAM-D) [ Time Frame: Baseline, 6 weeks, 12 weeks ] [ Designated as safety issue: No ]
Mini Mental State Examination (MMSE) [ Time Frame: Baseline, 6 weeks, 12 weeks ] [ Designated as safety issue: No ]
NINCDS-CSN Vascular Cognitive Impairment Battery [ Time Frame: Baseline, 6 weeks, 12 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Centre for Epidemiological Studies-Depression Scale (CES-D) [ Time Frame: Baseline, 6 weeks, 12 weeks ] [ Designated as safety issue: No ]
Modified Rankin Scale (mRS) [ Time Frame: Baseline, 6 weeks, 12 weeks ] [ Designated as safety issue: No ]
NIH Stroke Scale [ Time Frame: Baseline, 6 weeks, 12 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment:	100
Study Start Date:	June 2005
Estimated Study Completion Date:	June 2011
Estimated Primary Completion Date:	January 2011 (Final data collection date for primary outcome measure)

Intervention Details:

If patients are found to be depressed, they will be referred to study doctors for treatment.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00254020

Contacts

Contact: Krista L Lanctot, PhD

(416) 480-6100 ext 2241

krista.lanctot@sunnybrook.ca

Locations

Canada, Ontario
Sunnybrook Health Sciences Centre	Recruiting
Toronto, Ontario, Canada, M4N 3M5
Contact: Krista L Lanctot, PhD (416) 480-6100 ext 2241 krista.lanctot@sunnybrook.ca
Principal Investigator: Krista L Lanctot, PhD
Sub-Investigator: Nathan Herrmann, MD
Sub-Investigator: Sandra E Black, MD
Sub-Investigator: David J Gladstone, MD
Sub-Investigator: Richard Aviv, MD
Sub-Investigator: Fuqiang Gao, PhD
Toronto Rehabilitation Institute	Recruiting
Toronto, Ontario, Canada, M4G 1R7
Contact: Abe Snaiderman, MD a.snaiderman@utoronto.ca
Principal Investigator: Abe Snaiderman, MD
Baycrest	Recruiting
Toronto, Ontario, Canada, M6A 2E1
Contact: Jon Ween, MD (416) 785-2500 ext 3636 jween@klaru-baycrest.on.ca
Sub-Investigator: Jon Ween, MD
York Central Hospital	Recruiting
Richmond Hill, Ontario, Canada, L4C 4Z3
Contact: Warren Goldstein, M.D. (905) 737-9677
Sub-Investigator: Warren Goldstein, M.D.
St. John's Rehabilitation Hospital	Recruiting
Toronto, Ontario, Canada, M2M 2G1
Contact: Murray Waldman, M.D. MWaldman@stjohnsrehab.com
Sub-Investigator: Murray Waldman, M.D.

Sponsors and Collaborators

Sunnybrook Health Sciences Centre

Investigators

Principal Investigator:

Krista L Lanctot, PhD

Sunnybrook Health Sciences Centre

More Information

No publications provided

Responsible Party:	Sunnybrook Health Sciences Centre ( Dr. Krista Lanctôt )
Study ID Numbers:	380-2004
Study First Received:	November 10, 2005
Last Updated:	February 4, 2009
ClinicalTrials.gov Identifier:	NCT00254020 History of Changes
Health Authority:	Canada: Health Canada

Keywords provided by Sunnybrook Health Sciences Centre:

stroke
depression
cytokines
serotonin
citalopram

Study placed in the following topic categories:

Neurotransmitter Agents
Depression
Cerebral Infarction
Stroke
Psychotropic Drugs
Depressive Disorder
Serotonin Uptake Inhibitors
Citalopram

Serotonin
Behavioral Symptoms
Mental Disorders
Mood Disorders
Dexetimide
Antidepressive Agents, Second-Generation
Antidepressive Agents

Additional relevant MeSH terms:

Neurotransmitter Agents
Neurotransmitter Uptake Inhibitors
Depression
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Psychotropic Drugs
Depressive Disorder
Serotonin Uptake Inhibitors
Citalopram
Serotonin

Pharmacologic Actions
Behavioral Symptoms
Serotonin Agents
Mental Disorders
Therapeutic Uses
Mood Disorders
Antidepressive Agents, Second-Generation
Central Nervous System Agents
Antidepressive Agents

ClinicalTrials.gov processed this record on September 02, 2009