The Efficacy of Citalopram Treatment in Acute Stroke (TALOS)

University of Aarhus

Status and phase

Completed

Phase 2

Conditions

Stroke, Ischemic

Treatments

Drug: Placebo

Drug: Citalopram

Study type

Interventional

Funder types

Other

Identifiers

NCT01937182

2013-002253-30

Details and patient eligibility

About

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.

Full 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.

Enrollment

642 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

First ever ischemic stroke
Age 18 years or above

Exclusion criteria

Hemorrhagic stroke
Dementia or other neurodegenerative disease
Antidepressant medical 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 (eGFR below 30 ml/min per 1.73m2)
Hyponatremia (S-potassium below 130 mmol/l)
Actively bleeding ulcer
Fatal stroke or other severe co-morbidity that markedly decreases expected life span
Prolonged corrected QT-interval (QTc above 480 ms)
Ongoing treatment with drugs known to prolong the QTc interval