To Evaluate the differences between teh length of delirium in the anti-psychotics+ melatonin group and the anti-psychotics + placebo group.
ID
Source
Brief title
Condition
- Deliria (incl confusion)
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Evaluate possible differences in duration of delirium between the
anti-psychotics + melatonin group and the anti-psychotics + placebo group.
Secondary outcome
* Evaluate possible differences in severity of delirium between the
anti-psychotics+ melatonin group and the anti-psychotics + placebo group.
* Compare possible differences in the length of hospital stay in delirious
patients in the anti-psychotics + melatonin group or anti-psychotics + placebo
group.
* Evaluate possible differences in the total dose of additional benzodiazepines
used to treat delirium in both the anti-psychotics + melatonin group and the
anti-psychotics + placebo group.
* Evaluate possible differences in the total dose of haloperidol used during
the period of delirium in both the anti-psychotics + melatonin group and the
anti-psychotics + placebo group.
* Evaluate the possible effects of delirium and of melatonin therapy on
cognitive decline 3 months and 12 months after hospital admission.
* Evaluate possible effects of delirium and of melatonin therapy on functional
decline, measured by grip-strength and by KATZ questionnaire.
Background summary
Delirium is a frequent problem during hospital admittance in the elderly
patient. The syndrome is characterized by symptoms of disturbed consciousness,
concentration and cognition which all have a fluctuating course, as well as
symptoms of disturbed sleeping patterns with awakening at night and sleepiness
at daytime. Delirium is a serious condition, associated with a three-time
increased mortality risk, higher institutionalisation rate and increased health
care costs. The disturbed sleeping patterns in patients with delirium might be
associated with a disturbed circadian rhythm of melatonin secretion. We propose
that treatment of delirium with melatonin, in addition to conventional
treatment with anti-psychotics, might be effective in reducing the duration of
delirium, which could result in a reduced length of hospital stay and its
associated costs.
Study objective
To Evaluate the differences between teh length of delirium in the
anti-psychotics+ melatonin group and the anti-psychotics + placebo group.
Study design
A randomized, double blind, placebo controlled trial.
Intervention
Treatment of patients with delirium with melatonin or placebo for a maximum of
10 ten days
Study burden and risks
Scientific benefits
Haloperidol and clozapine are recommended as first line drugs in the treatment
of delirium and is, apart from delirium, effective in the treatment of patients
with psychosis or psychotic depression. Both anti-psychotics however are known
to have neuro-psychiatric and/or cardiovascular side-effects related to
therapy, especially in frail elderly patients. If melatonin helps treating
delirium by restoring circadian rhythm, in the future less haloperidol will be
needed to treat delirium. Furthermore, by its sleep promoting effects,
melatonin might also decrease the need for additional benzodiazepines in the
treatment of delirium.
If such an observation could be demonstrated from this study it challenges the
general conclusion that haloperidol is not effective enough and suggests that
additional melatonin may be more beneficial in treatment of delirium symptoms.
Individual benefits
Possible benefits for subjects participating in this study are that delirium
and predisposing risk factors such as cognitive impairment will be assessed.
Also, they will be closely monitored for delirium during this study. The
symptoms of delirium and potential ADE*s are well controlled during the study.
Considering that the study population is at risk for (new) psychiatric illness
careful and close post-discharge follow up will be provided.
Meibergdreef 9
1105 AZ Amsterdam
NL
Meibergdreef 9
1105 AZ Amsterdam
NL
Listed location countries
Age
Inclusion criteria
1] Age 65 years or older
2] Acute hospital admission at medical ward
3] Patients diagnosed with delirium for which anti-psychotic therapy is needed.
4] Patients must be willing and medically able to receive therapy according to the protocol for the duration of the study
5] Written informed consent must be obtained
Exclusion criteria
1] Patients on medication that can*t speak or understand Dutch
2] Patients diagnosed with delirium who have received anti-psychotics longer than 24 hours.
3] Patients with a clinical diagnosis of hypoactive delirium
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| EudraCT | EUCTR2008-006452-22-NL |
| CCMO | NL25404.018.08 |