No registrations found.
ID
Source
Health condition
psychotic disorder
medication compliance
penfluridol
olanzapine
risperidone
Sponsors and support
Psychiatry Department
Intervention
Outcome measures
Primary outcome
time to all-cause medication discontinuation
Secondary outcome
- healthcare related costs
- quality of life
- reason for treatment discontinuation
- efficacy
- safety and tolerability
- drug attitude
- subjective well-being
- insight
Background summary
The aim of this study is to determine the long-term effectiveness and tolerability of penfluridol (acemap; oral long acting neuroleptic) and second generation oral neuroleptics (olanzapine, risperidone) using an open label randomized controlled trial design in 180 patients. One group receives penfluridol once weekly, one group receives onlanzapine once daily and the other group receives risperidone once daily as prescribed by the treating clinician, according to current conventional care, based on prescribed guidelines. The main study parameter will be time to all-cause medication discontinuation. Secondary endpoints include the reason for treatment discontinuation, efficacy, safety and tolerability, drug attitude, subjective well-being, insight, health care related costs and quality of life.
Study objective
We hypothesize that penfluridol as compared to oral second generation neuroleptics (olanzapine and risperidone), will show better compliance (primary outcome) and therefore lower healthcare costs.
Study design
- for primary outcome: 0,24,6,8,10,12 weeks, 6,9,12 months
- for secondary outcomes: 0,3,12 months
Intervention
comparison of (adherence of) two daily oral antipsychotics (olanzapine and risperidone) to a weekly oral antipsychotic (penfluridol)
C.L. Mulder
Erasmus MC, Research Center O3
Rotterdam 3066 TA
The Netherlands
+31 (0)6 27034001
Niels.clmulder@wxs.nl
C.L. Mulder
Erasmus MC, Research Center O3
Rotterdam 3066 TA
The Netherlands
+31 (0)6 27034001
Niels.clmulder@wxs.nl
Inclusion criteria
1. age 18-65 years
2. psychotic disorder, including schizophrenia, schizoaffective disorder, delusional disorder or psychosis not otherwise specified
3. treatment on an outpatient basis or inpatient treatment followed by outpatient care (expected duration of admission less than 6 weeks)
4. psychiatrist treating the patient decides that it is appropriate (based on clinical judgement, guidelines, history and symptoms of the patient) to prescribe either penfluridol, olanzapine or risperidone and that there are no decisive contra-indications
5. patient is willing to use oral neuroleptic treatment, including penfluridol, olanzapine or risperidone
6. able to give informed consent
Exclusion criteria
1. judicial order stating that taking medication is obliged
2. patient did use penfluridol during the previous six months
3. serious and unstable medical condition
4. insufficient proficiency in Dutch language
5. women who are pregnant
6. patient is on adequate antipsychotic therapy
Design
Recruitment
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 |
|---|---|
| NTR-new | NL6021 |
| NTR-old | NTR6152 |
| Other | NL51189.078.14 : 2014-003834-21 |