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'Effectiveness of Penfluridol (long acting neuroleptic) as compared to second generation oral neuroleptics (olanzapine and risperidone) in psychotic disorder patients: an open label randomized controlled trial'

'Effectiveness of Penfluridol (long acting neuroleptic) as compared to second generation oral neuroleptics in psychotic disorder patients: an open label randomized controlled trial'

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON26965
Enrollment
180
Registered
2016-12-28
Start date
2017-01-01
Completion date
Unknown
Last updated
2024-02-28

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

Conditions

psychotic disorder medication compliance penfluridol olanzapine risperidone

Interventions

comparison of (adherence of) two daily oral antipsychotics (olanzapine and risperidone) to a weekly oral antipsychotic (penfluridol)

Sponsors

Erasmus University Medical Center, Rotterdam Psychiatry Department
Lead Sponsor

Eligibility

Inclusion criteria

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

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 outcomes

Primary

MeasureTime frame
time to all-cause medication discontinuation

Secondary

MeasureTime frame
- healthcare related costs - quality of life - reason for treatment discontinuation - efficacy - safety and tolerability - drug attitude - subjective well-being - insight

Contacts

Public ContactC.L. Mulder

Prins Constantijnweg 48-54

Niels.clmulder@wxs.nl+31 (0)6 27034001

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)