drugset / Trial / NCT01937182
The Efficacy of Citalopram Treatment in Acute Stroke
Phase 2
Completed
642 enrolled
University of Aarhus
Danish Council for Independent Research · collabThe Danish Regions Medicine Foundation · collab
RandomizedParallel-groupQuadruple-blindTreatment
Summary
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.
Timeline
- Start
- 2013-09
- Primary completion
- 2016-12-19
- Completion
- 2016-12-19
Publications
- Background Siepmann T, Penzlin AI, Kepplinger J, Illigens BM, Weidner K, Reichmann H, Barlinn K. Selective serotonin reuptake inhibitors to improve outcome in acute ischemic stroke: possible mechanisms and clinical evidence. Brain Behav. 2015 Sep 23;5(10):e00373. doi: 10.1002/brb3.373. eCollection 2015 Oct.
- Background Bonaventura A, Liberale L, Vecchie A, Casula M, Carbone F, Dallegri F, Montecucco F. Update on Inflammatory Biomarkers and Treatments in Ischemic Stroke. Int J Mol Sci. 2016 Nov 25;17(12):1967. doi: 10.3390/ijms17121967.
- Background Mortensen JK, Johnsen SP, Larsson H, Andersen G. Early Antidepressant Treatment and All-Cause 30-Day Mortality in Patients with Ischemic Stroke. Cerebrovasc Dis. 2015;40(1-2):81-90. doi: 10.1159/000435819. Epub 2015 Jul 11.
- Background Adelborg K, Sundboll J, Videbech P, Grove EL. The Risk of Thromboembolism in Users of Antidepressants and Antipsychotics. Adv Exp Med Biol. 2017;906:351-361. doi: 10.1007/5584_2016_125.
- Vestergaard SB, Damsbo AG, Blauenfeldt RA, Johnsen SP, Andersen G, Mortensen JK. Impact of prestroke physical activity and citalopram treatment on poststroke depressive symptoms: a secondary analysis of data from the TALOS randomised controlled trial in Denmark. BMJ Open. 2023 Mar 30;13(3):e070822. doi: 10.1136/bmjopen-2022-070822.
- Kraglund KL, Mortensen JK, Damsbo AG, Modrau B, Simonsen SA, Iversen HK, Madsen M, Grove EL, Johnsen SP, Andersen G. Neuroregeneration and Vascular Protection by Citalopram in Acute Ischemic Stroke (TALOS). Stroke. 2018 Nov;49(11):2568-2576. doi: 10.1161/STROKEAHA.117.020067.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Citalopram | Small molecule | 10 mg | Oral |
| Comparator | Citalopram | Small molecule | 20 mg | Oral |