The Efficacy of Citalopram Treatment in Acute Stroke (TALOS)
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|ClinicalTrials.gov Identifier: NCT01937182|
Recruitment Status : Completed
First Posted : September 9, 2013
Last Update Posted : February 24, 2017
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.
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.
|Condition or disease||Intervention/treatment||Phase|
|Stroke, Ischemic||Drug: Citalopram Drug: Placebo||Phase 2|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||642 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||The Efficacy of Citalopram Treatment in Acute Stroke|
|Actual Study Start Date :||September 2013|
|Actual Primary Completion Date :||December 19, 2016|
|Actual Study Completion Date :||December 19, 2016|
Active Comparator: Selective Serotonin Reuptake Inhibitors
Intervention Drug: Citalopram
Citalopram 10-40 mg per day administered orally
Placebo Comparator: Placebo
Intervention Drug: Placebo
1/2-2 tablets per day with no intrinsic drug activity
- Vascular death, Transient Ischemic Attack (TIA)/stroke and myocardial infarction (combined) [ Time Frame: 6 months ]Myocardial Infarction: STEMI (ST segment elevation myocardial infarction) and NSTEMI (non-ST segment elevation myocardial infarction)
- Functional status at 6-months [ Time Frame: 6 months ]Functional status at 6-months, measured by the modified Rankin Scale
- Vascular death [ Time Frame: 6 months ]
- Death of any cause [ Time Frame: 6 months ]
- TIA/stroke [ Time Frame: 6 months ]
- Bleeding [ Time Frame: 6 months ]Using the Global Utilization Of Streptokinase And Tpa For Occluded Arteries definition for bleeding (GUSTO)
- Myocardial infarction [ Time Frame: 6 months ]STEMI (ST segment elevation myocardial infarction) and NSTEMI (non-ST segment elevation myocardial infarction)
- Disability/dependence [ Time Frame: 6 months ]Using the modified Rankin Scale and the Barthel Index (BI)
- Physical activity [ Time Frame: 6 months ]Using the Physical Activity Scale for the Elderly (PASE)
- Cognitive and organic cerebral impairment [ Time Frame: 6 months ]Using the Mini-Mental State Examination and the Symbol Digit Modalities Test
- Fatigue [ Time Frame: 6 months ]Using the Multidimensional Fatigue Inventory
- Post-stroke depression [ Time Frame: 6 months ]Using the Major Depression Inventory test (MDI), Global depression scale (self and clinician and Hamilton Depression Scale - 6 item (HAM-D6)
- Pathological Crying [ Time Frame: 6 months ]Using the Pathological Crying Scale
- Lesion size [ Time Frame: 6 months ]Using FLAIR positive lesion size on MRI 24 hours after treatment with Alteplase
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01937182
|Aalborg University Hospital, Department of Neurology|
|Aalborg, Denmark, 9100|
|Aarhus University Hospital, Department of Neurology|
|Aarhus, Denmark, 8000|
|Glostrup University Hospital, Department of Neurology|
|Glostrup, Denmark, 2600|
|Study Chair:||Grethe Andersen, DSMc||Aarhus University Hospital|
|Study Director:||Kristian L Kraglund, M.D.||Aarhus University Hospital|
|Principal Investigator:||Boris Modrau, M.D.||Aalborg University Hospital|
|Principal Investigator:||Helle Iversen, DSMc||Glostrup University Hospital|