Back to resultsMelatonin for Prevention of Post Stroke Delirium
Primary Purpose
Post Stroke Delirium
Status
Unknown status
Phase
Phase 2
Locations
Germany
Study Type
Interventional
Intervention
Melatonin
Sponsored by
About this trial
This is an interventional prevention trial for Post Stroke Delirium focused on measuring Melatonin
Eligibility Criteria
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
Sites / Locations
- Klinik für NeurologieRecruiting
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
Melatonin versus standard care
Arm Description
Melatonin is tested versus standard care
Outcomes
Primary Outcome Measures
Change of delir prevalence
Secondary Outcome Measures
Change of hospital stay
Change of antipsychotic drug administration
Changed stay on stroke unit and/or intermediate care
Full Information
NCT ID
NCT04122599
First Posted
May 29, 2019
Last Updated
October 9, 2019
Sponsor
University Hospital Tuebingen
1. Study Identification
Unique Protocol Identification Number
NCT04122599
Brief Title
Melatonin for Prevention of Post Stroke Delirium
Official Title
Melatonin for Prevention of Post Stroke Delirium
Study Type
Interventional
2. Study Status
Record Verification Date
October 2018
Overall Recruitment Status
Unknown status
Study Start Date
July 1, 2017 (Actual)
Primary Completion Date
November 1, 2019 (Anticipated)
Study Completion Date
December 31, 2019 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital Tuebingen
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Post Stroke Delirium
Keywords
Melatonin
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 2, Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
2000 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Melatonin versus standard care
Arm Type
Other
Arm Description
Melatonin is tested versus standard care
Intervention Type
Drug
Intervention Name(s)
Melatonin
Intervention Description
Melatonin for prevent post stroke delirium
Primary Outcome Measure Information:
Title
Change of delir prevalence
Time Frame
3months
Secondary Outcome Measure Information:
Title
Change of hospital stay
Time Frame
3months
Title
Change of antipsychotic drug administration
Time Frame
3 months
Title
Changed stay on stroke unit and/or intermediate care
Time Frame
3 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Annerose Mengel, MD
Phone
004970712985354
Email
annerose.mengel@med.uni-tuebingen.de
Facility Information:
Facility Name
Klinik für Neurologie
City
Tübingen
State/Province
BW
ZIP/Postal Code
72076
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Annerose Mengel, MD
Email
annerose.mengle@med.uni-tuebingen.de
First Name & Middle Initial & Last Name & Degree
Christian Bosselmann, MD
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Melatonin for Prevention of Post Stroke Delirium
We'll reach out to this number within 24 hrs