The Role of Cytokine-Serotonin Interactions in Post-Strok... | NCT00254020

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

NCT00254020

Sponsor

Sunnybrook Health Sciences Centre

Status

Completed

Last Update Posted

Apr 28, 2017Actual

Enrollment

138Actual

Phase

Phase 4

Conditions

Depression

Interventions

Citalopram

Countries

Canada

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Apr 2017

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 2005

Primary Completion Date

Jan 2011Actual

Completion Date

Dec 2013Actual

First Submitted Date

Nov 10, 2005

First Submission Date that Met QC Criteria

Nov 10, 2005

First Posted Date

Nov 15, 2005Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 26, 2017

Last Update Posted Date

Apr 28, 2017Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

138Actual

Name	Type	Description	Arm Group Labels	Other Names
Citalopram	Drug	Patients who are found to have major depression will be referred to a psychologist		Celexa

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

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

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Krista L Lanctot, PhD	Sunnybrook Health Sciences Centre	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
York Central Hospital		Richmond Hill	Ontario	L4C 4Z3	Canada
St. John's Rehabilitation Hospital

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
25285006	Result	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.

ID	Term
D001526	Behavioral Symptoms
D001519	Behavior
D002561	Cerebrovascular Disorders
D001927	Brain Diseases

ID	Term
D011437	Propylamines
D000588	Amines
D009930	Organic Chemicals
D009570	Nitriles
D001572