Clinical trial NCT02840591: Ramelteon and Citicoline for Delirium
Official title: A Feasibility Study of Ramelteon and Citicoline for Delirium in a General Inpatient Hospital Population
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE4
Conditions: Delirium
Keywords: Citicoline, Ramelteon, Rozerem
Lead sponsor: University of Texas Southwestern Medical Center
Sponsor class: OTHER
First posted: 2016-07-21
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief 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.

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.

Eligibility 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

Primary outcomes:
measure: Number diagnosed and treated
timeFrame: End of study (anticipated 12 months from beginning of study)
Secondary outcomes:
measure: Frequency of serious, less serious, and minor adverse events as measured by a clinical interview aided by an adverse event checklist
timeFrame: Daily for 5 days
measure: Delirium prevalence
timeFrame: Baseline (Day 0)
Other outcomes:
measure: Delirium severity
timeFrame: Daily for 5 days
measure: Delirium duration
timeFrame: Daily for 5 days
measure: Length of hospital stay
timeFrame: through study completion, an average of 1 year
Locations:
city: Dallas
country: United States
facility: The University of Texas Southwestern Medical Center at Dallas
state: Texas
Study officials:
affiliation: UT Southwestern Medical Center
name: E. Sherwood Brown, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: