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Trial record 65 of 590 for:    ESCITALOPRAM AND Celexa

Escitalopram Treatment In Acute Stroke (ESTIAS)

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ClinicalTrials.gov Identifier: NCT01561092
Recruitment Status : Withdrawn (Study medication could not be supplied. An alternative project will be conducted)
First Posted : March 22, 2012
Last Update Posted : June 19, 2012
Sponsor:
Collaborator:
Aarhus University Hospital
Information provided by (Responsible Party):
University of Aarhus

Tracking Information
First Submitted Date  ICMJE March 20, 2012
First Posted Date  ICMJE March 22, 2012
Last Update Posted Date June 19, 2012
Study Start Date  ICMJE Not Provided
Primary Completion Date Not Provided
Current Primary Outcome Measures  ICMJE
 (submitted: March 20, 2012)
New vascular events [ Time Frame: 6 months ]
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT01561092 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: March 26, 2012)
  • Death of any cause [ Time Frame: 6 months ]
  • Myocardial Infarction [ Time Frame: 6 months ]
  • Re-stroke [ Time Frame: 6 months ]
  • Motor function [ Time Frame: 6 months ]
    Fugl-Meyer Motor score is performed
  • White Matter lesions [ Time Frame: 6 months ]
    Evaluated on MRI
  • Bleeding complications [ Time Frame: 6 months ]
  • Combined vascular death [ Time Frame: 6 months ]
  • Cognitive abilities [ Time Frame: 6 months ]
    SDMT and MMSE tests are performed
Original Secondary Outcome Measures  ICMJE
 (submitted: March 20, 2012)
  • Death of any cause [ Time Frame: 6 months ]
  • Myocardial Infarction [ Time Frame: 6 months ]
  • Re-stroke [ Time Frame: 6 months ]
  • Motor and cognitive abilities [ Time Frame: 6 months ]
  • White Matter lesions [ Time Frame: 6 months ]
  • Bleeding complications [ Time Frame: 6 months ]
  • Combined vascular death [ Time Frame: 6 months ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Escitalopram Treatment In Acute Stroke
Official Title  ICMJE Efficacy of Escitalopram Treatment in Acute Stroke and the Role of SERT Genotype in Stroke
Brief Summary

Growing international scientific evidence has indicated a positive effect of SSRI treatment (serotonin reuptake inhibitors) after stroke, beyond its antidepressant effect. We wish to conduct a prospective randomised double blind placebo-controlled multicenter study of the combined neuroprotective and antithrombotic effects of SSRI treatment after stroke. Deletion of the SERT (serotonin transporter) gene may influence this treatment effect and may in itself be a risk factor for stroke, an aspect we also wish to explore.

Hypotheses:

  1. SSRI treatment commenced in the acute phase of stroke (day 2-5) protects against new thromboembolic events and leads to better rehabilitation.
  2. A specific SERT genotype is associated with an increased risk of first ever stroke.
  3. A specific SERT genotype is associated with a higher risk of post stroke depression.

600 stroke patients will be randomised to either escitalopram or placebo treatment in a 1:1 ratio and genotyped according to SERT polymorphisms. The treatment and follow up period is 6 months. During these 6 months there will be 2 clinical follow up visits, one telephone control and one visit to evaluate compliance regarding medication. Patients who had an MRI as a part of the routine investigations done upon admission (approximately 300 patients) will have a control MRI after 6 months.

Additionally 400 patients, not eligible for participation i the randomised controlled trial, will be genotyped and answer questionnaires after 1 and 6 months.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Stroke
Intervention  ICMJE
  • Drug: Escitalopram
    5 or 10 mg escitalopram tablets administered orally once daily
    Other Names:
    • SSRI
    • Cipralex
  • Drug: Placebo
    Tablets
Study Arms  ICMJE
  • Active Comparator: Escitalopram
    Intervention: Drug: Escitalopram
  • Placebo Comparator: Non active drug
    Intervention: Drug: Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Withdrawn
Actual Enrollment  ICMJE
 (submitted: June 18, 2012)
0
Original Estimated Enrollment  ICMJE
 (submitted: March 20, 2012)
600
Study Completion Date  ICMJE Not Provided
Primary Completion Date Not Provided
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • First ever ischemic stroke
  • Age 18 years or above

Exclusion Criteria

  • Hemorrhagic stroke
  • Dementia or other neurodegenerative disease
  • Antidepressant treatment within 6 months of admission
  • Acute need for antidepressant treatment
  • Drug abuse or other conditions that may indicate noncompliant behavior
  • Liver failure (increased liver enzyme levels up to or more than 2 times upper limit)
  • Renal failure (GFR under 30)
  • Hyponatremia (S-potassium below 130 mmol/l)
  • Actively bleeding ulcer
  • Fatal stroke or other severe co morbidity that markedly decreases expected life span
  • Prolonged QT interval (QTc above 500 ms)
  • Ongoing treatment with drugs known to prolong the QT interval
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Denmark
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01561092
Other Study ID Numbers  ICMJE 397-2011
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party University of Aarhus
Study Sponsor  ICMJE University of Aarhus
Collaborators  ICMJE Aarhus University Hospital
Investigators  ICMJE
Principal Investigator: Grethe Andersen, Prof. DMSc University Hospital of Aarhus, Neurology Dept.
PRS Account University of Aarhus
Verification Date June 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP