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Melatonin for Prevention of Post Stroke Delirium

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT04122599
Recruitment Status : Recruiting
First Posted : October 10, 2019
Last Update Posted : October 10, 2019
Information provided by (Responsible Party):
University Hospital Tuebingen

Brief Summary:
Post stroke delirium is prevalent in 10-30% of all stroke patients. We aimed to investigate wether Melatonin 2mg may prevent post stroke delirium.

Condition or disease Intervention/treatment Phase
Post Stroke Delirium Drug: Melatonin Phase 2 Phase 3

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 2000 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Melatonin for Prevention of Post Stroke Delirium
Actual Study Start Date : July 1, 2017
Estimated Primary Completion Date : November 1, 2019
Estimated Study Completion Date : December 31, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Delirium
Drug Information available for: Melatonin

Arm Intervention/treatment
Melatonin versus standard care
Melatonin is tested versus standard care
Drug: Melatonin
Melatonin for prevent post stroke delirium

Primary Outcome Measures :
  1. Change of delir prevalence [ Time Frame: 3months ]

Secondary Outcome Measures :
  1. Change of hospital stay [ Time Frame: 3months ]
  2. Change of antipsychotic drug administration [ Time Frame: 3 months ]
  3. Changed stay on stroke unit and/or intermediate care [ Time Frame: 3 months ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   55 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • all patients with stroke, TIA or ICH admitted to our stroke unit or intemdiate care unit
  • Stroke / ICH /TIA onset <= 48h

Exclusion Criteria:

  • RASS <=4
  • severe dementia, psychosis or depression

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 identifier (NCT number): NCT04122599

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Contact: Annerose Mengel, MD 004970712985354

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Klinik für Neurologie Recruiting
Tübingen, BW, Germany, 72076
Contact: Annerose Mengel, MD   
Contact: Christian Bosselmann, MD         
Sponsors and Collaborators
University Hospital Tuebingen

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Responsible Party: University Hospital Tuebingen Identifier: NCT04122599     History of Changes
Other Study ID Numbers: 752/2018BO2
First Posted: October 10, 2019    Key Record Dates
Last Update Posted: October 10, 2019
Last Verified: October 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University Hospital Tuebingen:
Additional relevant MeSH terms:
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Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Neurobehavioral Manifestations
Neurologic Manifestations
Signs and Symptoms
Neurocognitive Disorders
Mental Disorders
Molecular Mechanisms of Pharmacological Action
Protective Agents
Physiological Effects of Drugs
Central Nervous System Depressants