Ramelteon and Citicoline for Delirium

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

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.

Study Overview

• Status: Withdrawn
• Conditions: Delirium
• Intervention / Treatment: Drug: Ramelteon; Drug: Citicoline

Detailed 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.

• Study Type: Interventional
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • Texas
    • Dallas, Texas, United States, 75390
      • The University of Texas Southwestern Medical Center at Dallas

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Drug Treatment; First 5 consecutive subjects: Ramelteon 8 mg daily at 8 pm for 5 days; Next 5 consecutive subjects: Citicoline 250 mg daily at 8 pm for 2 days, followed by citicoline 500 mg daily at 8 pm for 3 days; All subjects: Standard medical care	Drug: Ramelteon; Other Names: Rozerem; Drug: Citicoline
No Intervention: Observation-Only; Standard medical care

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
Delirium prevalence	Number of subjects diagnosed with delirium according to Diagnostic and Statistical Manual (DSM)-5 criteria	Baseline (Day 0)

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Delirium severity	Score on Delirium Rating Scale-Revised (DRS-R98)	Daily for 5 days
Delirium duration	Number of days a subject continues to fulfill criteria for DSM-5 delirium diagnosis	Daily for 5 days
Length of hospital stay	Measured in days	through study completion, an average of 1 year

Collaborators and Investigators

• Sponsor: University of Texas Southwestern Medical Center

Study record dates

Study Major Dates

• Study Start: July 1, 2016
• Primary Completion (Actual): November 1, 2017
• Study Completion (Actual): November 1, 2017

Study Registration Dates

• First Submitted: July 15, 2016
• First Submitted That Met QC Criteria: July 20, 2016
• First Posted (Estimate): July 21, 2016

Study Record Updates

• Last Update Posted (Actual): November 9, 2017
• Last Update Submitted That Met QC Criteria: November 7, 2017
• Last Verified: November 1, 2017

More Information

Terms related to this study

• Keywords: Citicoline, Ramelteon, Rozerem
• Additional Relevant MeSH Terms: Mental Disorders; Nervous System Diseases; Neurologic Manifestations; Confusion; Neurobehavioral Manifestations; Neurocognitive Disorders; Delirium; Nootropic Agents; Cytidine Diphosphate Choline
• Other Study ID Numbers: 042016-063

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No