Ramelteon and Citicoline for Delirium
| Status: | Withdrawn |
|---|---|
| Conditions: | Neurology, Psychiatric |
| Therapuetic Areas: | Neurology, Psychiatry / Psychology |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 11/11/2017 |
| Start Date: | July 2016 |
| End Date: | November 2017 |
A Feasibility Study of Ramelteon and Citicoline for Delirium in a General Inpatient Hospital Population
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.
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.
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.
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.
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
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