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Ramelteon and Citicoline for Delirium

NCT ID: NCT02840591

Last Updated: 2017-11-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

PHASE4

Study Classification

INTERVENTIONAL

Study Start Date

2016-07-31

Study Completion Date

2017-11-30

Brief Summary

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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

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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.

Conditions

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Delirium

Keywords

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Citicoline, Ramelteon, Rozerem

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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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

Group Type EXPERIMENTAL

Ramelteon

Intervention Type DRUG

Citicoline

Intervention Type DRUG

Observation-Only

Standard medical care

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Ramelteon

Intervention Type DRUG

Citicoline

Intervention Type DRUG

Other Intervention Names

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Rozerem

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Texas Southwestern Medical Center

OTHER

Sponsor Role lead

Responsible Party

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Sherwood Brown

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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E. Sherwood Brown, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

UT Southwestern Medical Center

Locations

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The University of Texas Southwestern Medical Center at Dallas

Dallas, Texas, United States

Site Status

Countries

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United States

Other Identifiers

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042016-063

Identifier Type: -

Identifier Source: org_study_id