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Clinical effects of low dose pipamperone (Dipiperone) versus placebo on cognitive functions of elderly patients suffering from cognitive dysfunction, admitted at a general hospital.

Phase 4
Recruiting
Conditions
confusion
cognitive dysfunction
10009841
Registration Number
NL-OMON30224
Lead Sponsor
GGZ Drenthe (Assen)
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Recruiting
Sex
Not specified
Target Recruitment
88
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.

Study & Design

Study Type
Interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
<p>The results of the first and second MMSE will be taken into account, the<br /><br>positive or negative difference between these two will represent the effect of<br /><br>pipamperone on the cognitive functions of elderly people admitted at a general<br /><br>hospital. The doubleblind randomisation will rule out any effects caused by,<br /><br>e.g., physical recovery.</p><br>
Secondary Outcome Measures
NameTimeMethod
<p>Not applicable.</p><br>
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