Melatonin for Prevention of Post Stroke Delirium

Phase 2

• Conditions: Post Stroke Delirium
• Interventions: Drug: Melatonin

• Registration Number: NCT04122599
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2017-07-01
• Status Verified: 2018-10
• Study First Submitted: 2019-05-29
• Study First Submitted QC: 2019-10-09
• Last Update Submitted: 2019-10-09
• Study First Posted: 2019-10-10
• Last Update Posted: 2019-10-10
• Primary Completion: 2019-11-01
• Study Completion: 2019-12-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 2000

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Melatonin versus standard care	Melatonin	Melatonin is tested versus standard care

Primary Outcome Measures

Name	Time	Method
Change of delir prevalence	3months

Secondary Outcome Measures

Name	Time	Method
Change of hospital stay	3months
Change of antipsychotic drug administration	3 months
Changed stay on stroke unit and/or intermediate care	3 months

Trial Locations

Locations (1)

Klinik für Neurologie; 🇩🇪 Tübingen, BW, Germany