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Stroke, IschemicPhase 2TALOSNCT01937182

The Efficacy of Citalopram Treatment in Acute Stroke

A Phase 2 study testing Citalopram in people with Stroke, Ischemic, run by University of Aarhus at 3 sites in Denmark.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Stroke, Ischemic
What is being tested?
Citalopram
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
642 participants
Where
3 sitesDenmark
Study dates
Sep 2013to 19 Dec 2016
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • First ever ischemic stroke
  • Age 18 years or above

Who cannot join

  • 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)
Show all 12Show fewer
  • 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

Trial locations and contacts

3 sites in 1 country.

Denmark3 sites

  • Aalborg University Hospital, Department of Neurology

    Aalborg, 9100

  • Aarhus University Hospital, Department of Neurology

    Aarhus, 8000

  • Glostrup University Hospital, Department of Neurology

    Glostrup Municipality, 2600

Other trials in Denmark

About this study

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.

Read the detailed 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.

Being tested
Citalopram, Placebo
Keywords
Stroke, SSRI (Selective Serotonin Reuptake Inhibitors), Serotonin, 5-HT (5-Hydroxytryptamine), Neuroprotection, MRI (Magnetic Resonance Imaging), Platelet, CT (computerized tomography), Post Stroke Depression
Medical subject headings
Ischemic Stroke, Stroke

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • CitalopramDrug

    Also called Selective Serotonin Reuptake Inhibitors, SSRI, Seropram®, Cipramil®

    Citalopram 10-40 mg per day administered orally

  • PlaceboDrug

    Also called inactive drug, inactive medicine, inactive substance

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

Study groups in NCT01937182
Study groupRoleWhat they receive
Selective Serotonin Reuptake InhibitorsActive comparatorIntervention Drug: Citalopram
Receives: Drug: Citalopram
PlaceboPlacebo comparatorIntervention Drug: Placebo
Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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)

    Measured: 6 months

  2. Functional status at 6-months

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

    Measured: 6 months

Secondary outcomes (12)

  1. Vascular death

    Measured: 6 months

  2. Death of any cause

    Measured: 6 months

  3. TIA/stroke

    Measured: 6 months

  4. Bleeding

    Using the Global Utilization Of Streptokinase And Tpa For Occluded Arteries definition for bleeding (GUSTO)

    Measured: 6 months

  5. Myocardial infarction

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

    Measured: 6 months

  6. Disability/dependence

    Using the modified Rankin Scale and the Barthel Index (BI)

    Measured: 6 months

  7. Physical activity

    Using the Physical Activity Scale for the Elderly (PASE)

    Measured: 6 months

  8. Cognitive and organic cerebral impairment

    Using the Mini-Mental State Examination and the Symbol Digit Modalities Test

    Measured: 6 months

  9. Fatigue

    Using the Multidimensional Fatigue Inventory

    Measured: 6 months

  10. Post-stroke depression

    Using the Major Depression Inventory test (MDI), Global depression scale (self and clinician and Hamilton Depression Scale - 6 item (HAM-D6)

    Measured: 6 months

  11. Pathological Crying

    Using the Pathological Crying Scale

    Measured: 6 months

  12. Lesion size

    Using FLAIR positive lesion size on MRI 24 hours after treatment with Alteplase

    Measured: 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted9 Sep 2013 (estimated)
  2. Study startSep 2013
  3. Primary completion19 Dec 2016
  4. Study completion19 Dec 2016

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
642 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01937182
Sponsor's protocol ID
2013-002253-30
Acronym
TALOS
Status last verified
Dec 2016
First submitted
3 Sep 2013
Last updated
24 Feb 2017
Results posted
No
Data monitoring committee
Yes

Publications

  • 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.

    PubMed 26516608

  • 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.

    PubMed 27898011

  • 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.

    PubMed 26184925

  • 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.

    PubMed 27638627

  • 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.

    PubMed 36997260

  • 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.

    PubMed 30355209

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Citalopram in people with Stroke, Ischemic, run by University of Aarhus at 3 sites in Denmark.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 24 Feb 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Vascular death, Transient Ischemic Attack (TIA)/stroke and myocardial infarction (combined) (time frame: 6 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01937182, which also lists 6 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Feb 2017.

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