Melatonin for Prevention of Post Stroke Delirium

Post Stroke Delirium Clinical Trial

Official title:

Melatonin for Prevention of Post Stroke Delirium

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04122599
• Other study ID #: 752/2018BO2
• Status: Recruiting
• Phase: Phase 2/Phase 3
• Start date: July 1, 2017
• Est. completion date: December 31, 2019

Study information

• Verified date: October 2018
• Source: University Hospital Tuebingen
• Contact: Annerose Mengel, MD
• Phone: 004970712985354
• Email: annerose.mengel[@]med.uni-tuebingen.de
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 2000
• Est. completion date: December 31, 2019
• Est. primary completion date: November 1, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 55 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Delirium
• Post Stroke Delirium
• Stroke

Intervention

Drug:
• Melatonin
Melatonin for prevent post stroke delirium

Locations

Country	Name	City	State
Germany	Klinik für Neurologie	Tübingen	BW

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital Tuebingen

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change of delir prevalence		3months
Secondary	Change of hospital stay		3months
Secondary	Change of antipsychotic drug administration		3 months
Secondary	Changed stay on stroke unit and/or intermediate care		3 months