Melatonin for Prevention of Post Stroke Delirium

University Hospital Tuebingen

Status and phase: Unknown; Phase 3; Phase 2

Conditions: Post Stroke Delirium

Treatments: Drug: Melatonin

Study type: Interventional

Funder types: Other

Identifiers

NCT04122599

752/2018BO2

Details and patient eligibility

About

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

Enrollment: 2,000 estimated patients

Sex: All

Ages: 55+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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2,000 participants in 1 patient group

Melatonin versus standard care

Other group

Description:

Melatonin is tested versus standard care

Treatment:

Drug: Melatonin