To asses the clinical effect of low dose pipamperone on cognitive functions of elderly patients suffering from cognitive dysfunction.
ID
Source
Brief title
Condition
- Cognitive and attention disorders and disturbances
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The results of the first and second MMSE will be taken into account, the
positive or negative difference between these two will represent the effect of
pipamperone on the cognitive functions of elderly people admitted at a general
hospital. The doubleblind randomisation will rule out any effects caused by,
e.g., physical recovery.
Secondary outcome
Not applicable.
Background summary
Pipamperone (Dipiperone) is registered in the Netherlands for treating
psychosis, sleeping disorders in case of schizofrenic psychosis and for
treating children with a psychiatric disorder who show severe agressive
behaviour.
Pipamperone has a slight effect on the D2 receptor (blockage), on the alpha2
receptor (blockage), the ACh receptor (blockage), a stronger effect on the H1
receptor and a significant strong effect on the serotonin receptor.
Elderly patients admitted at hospital often show cognitive dysfunction on
behalf of their illness, disturbance of their familiar daily routine, change of
surroundings and medical interventions. Based on experience, we believe that
low dose pipamperon has a positive effect on cognitive functions of these
patients. Yet, there is no scientific evidence to support these beliefs.
Study objective
To asses the clinical effect of low dose pipamperone on cognitive functions of
elderly patients suffering from cognitive dysfunction.
Study design
The study will be double blind randomized controlled. Patients will be treated
by pipamperone drops or placebo (liquid drops, in appearance not different from
the pipamperone drops) to be able to rule out favourable effects on cognitive
functions provided by physical recovery. The pharmacy will provide the
pipamperone drops and placebo and will randomize the patient-placebo or
patient-pipamperone match.
Intervention
A Mini Mental State Examination (MMSE) will be taken on the same day that
patients are admitted or shortly after. This test will assess the cognitive
(dys)function of patients.
When a patient meets the criteria of inclusion, he or she will be administered
10 drops of pipamperone in the evening (40mg/ml = 20 mg).
Another MMSE will be taken before the patient will leave the hospital. At least
4 days must have been passed between the first time the MMSE is taken and the
second MMSE is taken.
Study burden and risks
Patients will be treated by pipamperone or placebo. Pipamperone will be
prescribed in a very low dose of which adverse effects will not be expected,
thus excluding any harm on account of the patient.
Dennenweg 9
9404 LA Assen
NL
Dennenweg 9
9404 LA Assen
NL
Listed location countries
Age
Inclusion criteria
- Patients who are clinically admitted (at the Wilhelmina Hospital in Assen, The Netherlands);
- Patients who score a minimum of 17 points and a maximum of 24 points on the Mini Mental State Examination (MMSE);
- The prognosis of the illness is favourable (patients are not terminally ill);
- Patients (or their legal representative) have given their written permission for participation in the study.
Exclusion criteria
- Patients who are suffering from a terminal illness, which is expected to be fatal on short term;
- There is a medical objection to treatment with pipamperone, e.g. the patient is suffering from Parkinson's disease, spastic paralysis, depression of the central nervous system, lesions of the basal ganglia, (severe) cardiovascular disease, severe organic cerebral disease or epilepsy.
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 | EUCTR2006-005313-35-NL |
| CCMO | NL14548.097.06 |