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Ramelteon and Citicoline for Delirium

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ClinicalTrials.gov Identifier: NCT02840591
Recruitment Status : Withdrawn (Stopped the study due to feasibility issues, no enrollment has taken place.)
First Posted : July 21, 2016
Last Update Posted : November 9, 2017
Sponsor:
Information provided by (Responsible Party):
Sherwood Brown, University of Texas Southwestern Medical Center

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.

Condition or disease Intervention/treatment Phase
Delirium Drug: Ramelteon Drug: Citicoline Phase 4

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: A Feasibility Study of Ramelteon and Citicoline for Delirium in a General Inpatient Hospital Population
Study Start Date : July 2016
Actual Primary Completion Date : November 2017
Actual Study Completion Date : November 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Delirium
Drug Information available for: Ramelteon

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 Name: Rozerem

Drug: Citicoline
No Intervention: Observation-Only
Standard medical care



Primary Outcome Measures :
  1. Number diagnosed and treated [ Time Frame: End of study (anticipated 12 months from beginning of study) ]
    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.


Secondary Outcome Measures :
  1. Frequency of serious, less serious, and minor adverse events as measured by a clinical interview aided by an adverse event checklist [ Time Frame: Daily for 5 days ]
  2. Delirium prevalence [ Time Frame: Baseline (Day 0) ]
    Number of subjects diagnosed with delirium according to Diagnostic and Statistical Manual (DSM)-5 criteria


Other Outcome Measures:
  1. Delirium severity [ Time Frame: Daily for 5 days ]
    Score on Delirium Rating Scale-Revised (DRS-R98)

  2. Delirium duration [ Time Frame: Daily for 5 days ]
    Number of days a subject continues to fulfill criteria for DSM-5 delirium diagnosis

  3. Length of hospital stay [ Time Frame: through study completion, an average of 1 year ]
    Measured in days



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02840591


Locations
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United States, Texas
The University of Texas Southwestern Medical Center at Dallas
Dallas, Texas, United States, 75390
Sponsors and Collaborators
University of Texas Southwestern Medical Center
Investigators
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Principal Investigator: E. Sherwood Brown, MD, PhD UT Southwestern Medical Center
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Responsible Party: Sherwood Brown, Professor, University of Texas Southwestern Medical Center
ClinicalTrials.gov Identifier: NCT02840591    
Other Study ID Numbers: 042016-063
First Posted: July 21, 2016    Key Record Dates
Last Update Posted: November 9, 2017
Last Verified: November 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Sherwood Brown, University of Texas Southwestern Medical Center:
Citicoline, Ramelteon, Rozerem
Additional relevant MeSH terms:
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Delirium
Confusion
Neurobehavioral Manifestations
Neurologic Manifestations
Nervous System Diseases
Neurocognitive Disorders
Mental Disorders
Cytidine Diphosphate Choline
Nootropic Agents