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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.

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

Status
Recruiting
Phases
Phase 4
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON30224
Enrollment
88
Registered
2007-02-12
Start date
2008-02-01
Completion date
Unknown
Last updated
2024-05-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

cognitive dysfunction

Interventions

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

Sponsors

GGZ Drenthe (Assen)
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

Inclusion criteria

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

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 outcomes

Primary

MeasureTime frame
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

MeasureTime frame
Not applicable.

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)