Ramelteon and Citicoline for Delirium

NCT02840591 | Withdrawn Phase 4

• 1 other identifier: 042016-063
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Delirium

Keywords

Citicoline, Ramelteon, Rozerem

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• 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

  Baseline (Day 0)

Other Outcomes (3)

• Delirium severity

  Daily for 5 days

• Delirium duration

  Daily for 5 days

• Length of hospital stay

  through study completion, an average of 1 year

Study Arms (2)

Drug Treatment

EXPERIMENTAL

* 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; Drug: Citicoline

Observation-Only

NO INTERVENTION

Standard medical care

Interventions

Ramelteon DRUG

Also known as: Rozerem

Drug Treatment

Citicoline DRUG

Drug Treatment

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Texas Southwestern Medical Center: lead

Study Sites (1)

The University of Texas Southwestern Medical Center at Dallas

Dallas, Texas, 75390, United States

Location

MeSH Terms

Conditions

Delirium

Interventions

ramelteon; Cytidine Diphosphate Choline

Condition Hierarchy (Ancestors)

Confusion; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Neurocognitive Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Choline; Trimethyl Ammonium Compounds; Quaternary Ammonium Compounds; Amines; Organic Chemicals; Onium Compounds; Cytidine Diphosphate; Cytosine Nucleotides; Pyrimidine Nucleotides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Nucleotides; Nucleic Acids, Nucleotides, and Nucleosides; Ribonucleotides

Study Officials

• E. Sherwood Brown, MD, PhD

  University of Texas Southwestern Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: July 15, 2016
• First Posted: July 21, 2016
• Study Start: July 1, 2016
• Primary Completion: November 1, 2017
• Study Completion: November 1, 2017
• Last Updated: November 9, 2017

Record last verified: 2017-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)