Ramelteon and Citicoline for Delirium

Delirium Clinical Trial

Official title:

A Feasibility Study of Ramelteon and Citicoline for Delirium in a General Inpatient Hospital Population

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT02840591
• Other study ID #: 042016-063
• Status: Withdrawn
• Phase: Phase 4
• First received: July 15, 2016
• Last updated: November 7, 2017
• Start date: July 2016
• Est. completion date: November 2017

Study information

• Verified date: November 2017
• Source: University of Texas Southwestern Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

This will be a 5-day, non-randomized, open-label, consecutive case series of ramelteon treatment followed by a separate consecutive case series of citicoline treatment, both running in parallel with a non-randomized, observation-only, treatment as usual arm in hospitalized patients with delirium.

On the drug treatment arm, first five consecutive subjects meeting Diagnostic and Statistical Manual (DSM)-5 criteria for delirium will be given ramelteon 8 mg daily at bedtime for 5 days. The next five consecutive patients will be given citicoline 250 mg daily at bedtime for 2 days, followed by 500 mg daily at bedtime for 3 days. Patients on the observation-only arm will be screened and followed similarly, except they will not be given any experimental drugs. All subjects will continue to receive standard medical care for delirium, including optimal medical treatment, psychotropic medications and consultations with specialty services as necessary.

The study is a small pilot to see if there is good feasibility, tolerability and a signal for delirium improvement efficacy with the two medications. The goal is to develop the ability to conduct delirium research at this institution and obtain some preliminary pilot data. These data will be used to design and obtain funding for future, larger research studies. the data from each medication will be examined to look for patterns suggesting that one may be preferable for further research. However, given the very small sample size, meaningful between-group statistical analyses are not possible.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: November 2017
• Est. primary completion date: November 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Delirium

Intervention

Drug:
• Ramelteon

• Citicoline

Locations

Country	Name	City	State
United States	The University of Texas Southwestern Medical Center at Dallas	Dallas	Texas

Sponsors (1)

Lead Sponsor	Collaborator
University of Texas Southwestern Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Delirium severity	Score on Delirium Rating Scale-Revised (DRS-R98)	Daily for 5 days
Other	Delirium duration	Number of days a subject continues to fulfill criteria for DSM-5 delirium diagnosis	Daily for 5 days
Other	Length of hospital stay	Measured in days	through study completion, an average of 1 year
Primary	Number diagnosed and treated	Number of subjects in each arm that are diagnosed with delirium and treated according to protocol. This is a feasibility measure, the investigators are measuring whether it is possible to screen, enroll, diagnose, treat and monitor a sufficient number of subjects with delirium at the study site.	End of study (anticipated 12 months from beginning of study)
Secondary	Frequency of serious, less serious, and minor adverse events as measured by a clinical interview aided by an adverse event checklist		Daily for 5 days
Secondary	Delirium prevalence	Number of subjects diagnosed with delirium according to Diagnostic and Statistical Manual (DSM)-5 criteria	Baseline (Day 0)