The Efficacy of Citalopram Treatment in Acute Stroke

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

642 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-09-30

Study Completion Date

2016-12-19

Brief Summary

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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.

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Detailed Description

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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

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Stroke, Ischemic

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Selective Serotonin Reuptake Inhibitors

Intervention Drug: Citalopram

Group Type ACTIVE_COMPARATOR

Citalopram

Intervention Type DRUG

Citalopram 10-40 mg per day administered orally

Placebo

Intervention Drug: Placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

1/2-2 tablets per day with no intrinsic drug activity

Interventions

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Citalopram

Citalopram 10-40 mg per day administered orally

Intervention Type DRUG

Placebo

1/2-2 tablets per day with no intrinsic drug activity

Intervention Type DRUG

Other Intervention Names

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Selective Serotonin Reuptake Inhibitors SSRI Seropram® Cipramil® inactive drug inactive medicine inactive substance

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No