Ramelteon and Citicoline for Delirium
|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Recruitment Status : Withdrawn (Stopped the study due to feasibility issues, no enrollment has taken place.)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
|Condition or disease||Intervention/treatment||Phase|
|Delirium||Drug: Ramelteon Drug: Citicoline||Phase 4|
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 (Clinical Trial)|
|Actual Enrollment :||0 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|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|
Experimental: Drug Treatment
Other Name: Rozerem
No Intervention: Observation-Only
Standard medical care
- 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.
- 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 ]
- Delirium prevalence [ Time Frame: Baseline (Day 0) ]Number of subjects diagnosed with delirium according to Diagnostic and Statistical Manual (DSM)-5 criteria
- Delirium severity [ Time Frame: Daily for 5 days ]Score on Delirium Rating Scale-Revised (DRS-R98)
- Delirium duration [ Time Frame: Daily for 5 days ]Number of days a subject continues to fulfill criteria for DSM-5 delirium diagnosis
- Length of hospital stay [ Time Frame: through study completion, an average of 1 year ]Measured in days
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02840591
|United States, Texas|
|The University of Texas Southwestern Medical Center at Dallas|
|Dallas, Texas, United States, 75390|
|Principal Investigator:||E. Sherwood Brown, MD, PhD||UT Southwestern Medical Center|