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Trial record 20 of 513 for:    ESCITALOPRAM AND Serotonin Uptake

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
Sponsor:
Collaborators:
Danish Council for Independent Research
The Danish Regions Medicine Foundation
Information provided by (Responsible Party):
University of Aarhus

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.


Condition or disease Intervention/treatment Phase
Stroke, Ischemic Drug: Citalopram Drug: Placebo Phase 2

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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 642 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Selective Serotonin Reuptake Inhibitors
Intervention Drug: Citalopram
Drug: Citalopram
Citalopram 10-40 mg per day administered orally
Other Names:
  • Selective Serotonin Reuptake Inhibitors
  • SSRI
  • Seropram®
  • Cipramil®

Placebo Comparator: Placebo
Intervention Drug: Placebo
Drug: Placebo
1/2-2 tablets per day with no intrinsic drug activity
Other Names:
  • inactive drug
  • inactive medicine
  • inactive substance




Primary Outcome Measures :
  1. 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)

  2. Functional status at 6-months [ Time Frame: 6 months ]
    Functional status at 6-months, measured by the modified Rankin Scale


Secondary Outcome Measures :
  1. Vascular death [ Time Frame: 6 months ]
  2. Death of any cause [ Time Frame: 6 months ]
  3. TIA/stroke [ Time Frame: 6 months ]
  4. Bleeding [ Time Frame: 6 months ]
    Using the Global Utilization Of Streptokinase And Tpa For Occluded Arteries definition for bleeding (GUSTO)

  5. Myocardial infarction [ Time Frame: 6 months ]
    STEMI (ST segment elevation myocardial infarction) and NSTEMI (non-ST segment elevation myocardial infarction)

  6. Disability/dependence [ Time Frame: 6 months ]
    Using the modified Rankin Scale and the Barthel Index (BI)

  7. Physical activity [ Time Frame: 6 months ]
    Using the Physical Activity Scale for the Elderly (PASE)

  8. Cognitive and organic cerebral impairment [ Time Frame: 6 months ]
    Using the Mini-Mental State Examination and the Symbol Digit Modalities Test

  9. Fatigue [ Time Frame: 6 months ]
    Using the Multidimensional Fatigue Inventory

  10. 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)

  11. Pathological Crying [ Time Frame: 6 months ]
    Using the Pathological Crying Scale

  12. Lesion size [ Time Frame: 6 months ]
    Using FLAIR positive lesion size on MRI 24 hours after treatment with Alteplase



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

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


Locations
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Denmark
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
Sponsors and Collaborators
University of Aarhus
Danish Council for Independent Research
The Danish Regions Medicine Foundation
Investigators
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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

Additional Information:
Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: University of Aarhus
ClinicalTrials.gov Identifier: NCT01937182     History of Changes
Other Study ID Numbers: 2013-002253-30
First Posted: September 9, 2013    Key Record Dates
Last Update Posted: February 24, 2017
Last Verified: December 2016

Keywords provided by University of Aarhus:
Stroke
SSRI (Selective Serotonin Reuptake Inhibitors)
Serotonin
5-HT (5-Hydroxytryptamine)
Neuroprotection
MRI (Magnetic Resonance Imaging)
Platelet
CT (computerized tomography)
Post Stroke Depression

Additional relevant MeSH terms:
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Serotonin
Citalopram
Dexetimide
Serotonin Uptake Inhibitors
Serotonin Receptor Agonists
Serotonin Agents
Neurotransmitter Uptake Inhibitors
Stroke
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Membrane Transport Modulators
Antidepressive Agents, Second-Generation
Antidepressive Agents
Psychotropic Drugs
Antiparkinson Agents
Anti-Dyskinesia Agents
Parasympatholytics
Autonomic Agents
Peripheral Nervous System Agents
Muscarinic Antagonists
Cholinergic Antagonists
Cholinergic Agents