Clinical effects of low dose pipamperon (Dipiperon) versus placebo on cognitive functions of elderly patients suffering from cognitive dysfunction, admitted at a general hospital.
- Conditions
- 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.
- Registration Number
- EUCTR2006-005313-35-NL
- Lead Sponsor
- GGZ Drenthe
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- All
- Target Recruitment
- 88
- Patients are clinically admitted (at the Wilhelmina Hospital in Assen, The Netherlands);
- Patients 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.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range
- Patients 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 Parkonson's disease, spastic paralysis, depression of the central nervous system, lesions of the basal ganglia, (severe) cardiovascular disease, severe organic cerebral disease or epilepsy.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: To asses the clinical effect of low dose pipamperone on cognitive functions of elderly patients suffering from cognitive dysfunction.<br><br><br>;Secondary Objective: ;Primary end point(s): Notion of the clinical effect of low dose pipamperone on cognitive functions of elderly patients suffering from cognitive dysfunction, admitted in a general hospital.
- Secondary Outcome Measures
Name Time Method