Ramelteon and Citicoline for Delirium

• Status: Withdrawn
• Trial end date: 2017-11-01
• Target enrollment: 0
• Participant gender: All

Summary

Primary aim of this study is to assess the feasibility of conducting clinical research for delirium (confusion due to medical problems) at Clements University Hospital in Dallas, Texas. A secondary aim is to assess whether an FDA-approved sleeping aid called Ramelteon or an over-the-counter supplement called Citicoline are safe and beneficial in delirium.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Texas Southwestern Medical Center
• Treatments: Cytidine Diphosphate Choline

Criteria

Inclusion Criteria:

• Admitted to inpatient units commonly known as 12-South or 12-North at Clements University Hospital

• Has capacity to give informed consent OR legally authorized representative is available at bedside

• Expected duration of hospitalization longer than 48 hours

• Fluent in English

• Can be screened by study physician within 24 hours of admission

Exclusion Criteria:

• History of angioedema or any other allergic reaction with previous ramelteon therapy

• Pregnant or currently breast-feeding

• Concurrent use of fluvoxamine

• Severe hepatic impairment

• Severe obstructive sleep apnea