The Efficacy of Citalopram Treatment in Acute Stroke "TALOS"

Recruiting

Phase 2 Results N/A

Trial Description

We wish to conduct a prospective, randomized, double blind, placebo controlled multi center study of the combined neuroprotective and antithrombotic effects of SSRI treatment after stroke.
Hypotheses:
SSRI treatment commenced in the acute phase of stroke (day 0-7) protects against new thromboembolic events and leads to better rehabilitation. 600 stroke patients will be randomized in a 1:1 ratio.
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.

Detailed Description

Design
 TALOS is an investigator-initiated, national multicenter randomized- and placebo-controlled, double blind trial testing citalopram in acute ischemic stroke.
Randomization Eligible patients will be randomized 1:1 to treatment with either citalopram or placebo. Treatment allocation is double-blinded based on computer-generated algorithm via a dedicated website. Patients whose treatment is stopped within 31 days after inclusion will be replaced.
Intervention and follow-up Patients randomized to citalopram will receive oral treatment with 20 mg tablets (10 mg if age ≥65 and/or reduced liver function) for 6 months with telephone contact after 2 weeks and 3 months and follow-up visits at 1 and 6 months. If patients develop depression dosage is initially doubled, followed by an additional control to evaluate effect and, if necessary, shifted to open-label antidepressant treatment. After 6 months, treatment will either stop or switch to open-label antidepressants at the discretion of the investigator.
Substudy 120 of patients will begin treatment within 12 hours after treatment with recombinant tissue plasminogen activator. These patients will receive a standard acute magnetic resonance imaging (MRI) with additional perfusion and angio sequences. The 24-hour control scan will be done using MRI instead of conventional CT.
Data monitoring When 300 patients have been included in the trial, an interim analysis will be performed. The unblinded results of this analysis will be reviewed by an independent data monitoring committee.

Conditions

Interventions

  • citalopram (Celexa)Drug
    Other Names: citalopram group
    Intervention Desc: Citalopram 10-40 mg per day administered orally
    ARM 1: Kind: Experimental
    Label: Selective Serotonin Reuptake Inhibitors
    Description: Intervention Drug: Citalopram
  • Placebo Drug
    Intervention Desc: 1/2-2 tablets per day with no intrinsic drug activity
    ARM 1: Kind: Experimental
    Label: Placebo
    Description: Intervention Drug: Placebo

Trial Design

  • Allocation: Randomized
  • Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
  • Purpose: Treatment
  • Endpoint: Efficacy Study
  • Intervention: Parallel Assignment

Outcomes

Type Measure Time Frame Safety Issue
Primary Combined vascular death, TIA/re-stroke and STEMI 6 months No
Secondary Death of any cause 6 months No
Secondary Myocardial Infarction 6 months No
Secondary Re-stroke 6 months No
Secondary Bleeding complications 6 months Yes
Secondary Combined vascular death 6 months No
Secondary Cognitive abilities 6 months No
Primary Vascular death, Transient Ischemic Attack (TIA)/stroke and myocardial infarction (combined) 6 months No
Primary Functional status at 6-months 6 months No
Secondary Vascular death 6 months No
Secondary TIA/stroke 6 months No
Secondary Bleeding 6 months No
Secondary Disability/dependence 6 months No
Secondary Physical activity 6 months No
Secondary Cognitive and organic cerebral impairment 6 months No
Secondary Fatigue 6 months No
Secondary Post-stroke depression 6 months No
Secondary Pathological Crying 6 months No
Secondary Lesion size 6 months No

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