NCT01937182

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
642

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Sep 2013

Typical duration for phase_2

Geographic Reach
1 country

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2013

Completed
2 days until next milestone

First Submitted

Initial submission to the registry

September 3, 2013

Completed
6 days until next milestone

First Posted

Study publicly available on registry

September 9, 2013

Completed
3.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 19, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 19, 2016

Completed
Last Updated

February 24, 2017

Status Verified

December 1, 2016

Enrollment Period

3.3 years

First QC Date

September 3, 2013

Last Update Submit

February 23, 2017

Conditions

Stroke, Ischemic

Keywords

StrokeSSRI (Selective Serotonin Reuptake Inhibitors)Serotonin5-HT (5-Hydroxytryptamine)NeuroprotectionMRI (Magnetic Resonance Imaging)PlateletCT (computerized tomography)Post Stroke Depression

Outcome Measures

Primary Outcomes (2)

  • Vascular death, Transient Ischemic Attack (TIA)/stroke and myocardial infarction (combined)

    Myocardial Infarction: STEMI (ST segment elevation myocardial infarction) and NSTEMI (non-ST segment elevation myocardial infarction)

    6 months

  • Functional status at 6-months

    Functional status at 6-months, measured by the modified Rankin Scale

    6 months

Secondary Outcomes (12)

  • Vascular death

    6 months

  • Death of any cause

    6 months

  • TIA/stroke

    6 months

  • Bleeding

    6 months

  • Myocardial infarction

    6 months

  • +7 more secondary outcomes

Study Arms (2)

Selective Serotonin Reuptake Inhibitors

ACTIVE COMPARATOR

Intervention Drug: Citalopram

Drug: Citalopram

Placebo

PLACEBO COMPARATOR

Intervention Drug: Placebo

Drug: Placebo

Interventions

CitalopramDRUG

Citalopram 10-40 mg per day administered orally

Also known as: Selective Serotonin Reuptake Inhibitors, SSRI, Seropram®, Cipramil®
Selective Serotonin Reuptake Inhibitors
PlaceboDRUG

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

Also known as: inactive drug, inactive medicine, inactive substance
Placebo

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • First ever ischemic stroke
  • Age 18 years or above

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Aalborg University Hospital, Department of Neurology

Aalborg, 9100, Denmark

Location

Aarhus University Hospital, Department of Neurology

Aarhus, 8000, Denmark

Location

Glostrup University Hospital, Department of Neurology

Glostrup Municipality, 2600, Denmark

Location

Related Publications (6)

  • 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.

    PMID: 26516608BACKGROUND

  • 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.

    PMID: 27898011BACKGROUND

  • 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.

    PMID: 26184925BACKGROUND

  • 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.

    PMID: 27638627BACKGROUND

  • 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.

    PMID: 36997260DERIVED

  • 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.

    PMID: 30355209DERIVED

Related Links

MeSH Terms

Conditions

Ischemic StrokeStroke

Interventions

CitalopramSelective Serotonin Reuptake InhibitorsDexetimide

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

PropylaminesAminesOrganic ChemicalsNitrilesBenzofuransHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic CompoundsNeurotransmitter Uptake InhibitorsMembrane Transport ModulatorsMolecular Mechanisms of Pharmacological ActionPharmacologic ActionsChemical Actions and UsesNeurotransmitter AgentsSerotonin AgentsPhysiological Effects of DrugsPiperidonesPiperidinesHeterocyclic Compounds, 1-Ring

Study Officials

  • Grethe Andersen, DSMc

    Aarhus University Hospital

    STUDY CHAIR

  • Kristian L Kraglund, M.D.

    Aarhus University Hospital

    STUDY DIRECTOR

  • Boris Modrau, M.D.

    Aalborg University Hospital

    PRINCIPAL INVESTIGATOR

  • Helle Iversen, DSMc

    Glostrup University Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 3, 2013

First Posted

September 9, 2013

Study Start

September 1, 2013

Primary Completion

December 19, 2016

Study Completion

December 19, 2016

Last Updated

February 24, 2017

Record last verified: 2016-12

Locations

DK(3)