Escitalopram Treatment In Acute Stroke

NCT01561092 | Withdrawn Phase 4 DMC

• 1 other identifier: 397-2011
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 3

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

Conditions

Stroke

Keywords

Stroke; RCT; SSRI; Outcome

Outcome Measures

Primary Outcomes (1)

• New vascular events

  6 months

Secondary Outcomes (8)

• Death of any cause

  6 months

• Myocardial Infarction

  6 months

• Re-stroke

  6 months

• Motor function

  6 months

• White Matter lesions

  6 months

Study Arms (2)

Escitalopram

ACTIVE COMPARATOR

Drug: Escitalopram

Non active drug

PLACEBO COMPARATOR

Drug: Placebo

Interventions

Escitalopram DRUG

5 or 10 mg escitalopram tablets administered orally once daily

Also known as: SSRI, Cipralex

Escitalopram

Placebo DRUG

Tablets

Non active drug

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• First ever ischemic stroke
• Age 18 years or above

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Aarhus: lead
• Aarhus University Hospital: collaborator

Study Sites (3)

Neurology Department, Aalborg Hospital

Aalborg, 9000, Denmark

Location

Neurology Department, University Hospital of Aarhus

Aarhus, 8000, Denmark

Location

Neurology Department, Glostrup Hospital

Glostrup Municipality, 2600, Denmark

Location

MeSH Terms

Conditions

Stroke

Interventions

Escitalopram; Dexetimide

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Propylamines; Amines; Organic Chemicals; Nitriles; Benzofurans; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Piperidones; Piperidines; Heterocyclic Compounds, 1-Ring

Study Officials

• Grethe Andersen, Prof. DMSc

  University Hospital of Aarhus, Neurology Dept.

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 20, 2012
• First Posted: March 22, 2012
• Last Updated: June 19, 2012

Record last verified: 2012-06

Locations

DK (3)