search  
 


Home

Who are we?

Why
register?


Signup for
registration


Online registration

Log in to register
your trial


Search a trial

NRT en CCMO

Contact

NEDERLANDS





MetaRegister
van CCT (UK)


ISRCTN-Register
van CCT (UK)


'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'


- candidate number25741
- NTR NumberNTR6152
- ISRCTNISRCTN no longer applicable
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR28-dec-2016
- Secondary IDs2014-003834-21 NL51189.078.14
- Public Title'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'
- Scientific Title'Effectiveness of Penfluridol (long acting neuroleptic) as compared to second generation oral neuroleptics in psychotic disorder patients: an open label randomized controlled trial'
- ACRONYM
- hypothesisWe hypothesize that penfluridol as compared to oral second generation neuroleptics (olanzapine and risperidone), will show better compliance (primary outcome) and therefore lower healthcare costs.
- Healt Condition(s) or Problem(s) studiedPsychotic disorders, Medication adherence
- Inclusion criteria1. 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 criteria1. 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
- mec approval receivedyes
- multicenter trialyes
- randomisedyes
- masking/blindingNone
- controlActive
- groupParallel
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 1-jan-2017
- planned closingdate1-jan-2019
- Target number of participants180
- Interventionscomparison of (adherence of) two daily oral antipsychotics (olanzapine and risperidone) to a weekly oral antipsychotic (penfluridol)
- Primary outcometime 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
- Timepoints- for primary outcome: 0,24,6,8,10,12 weeks, 6,9,12 months - for secondary outcomes: 0,3,12 months
- Trial web sitewww.oneforseven.nl
- statusplanned
- CONTACT FOR PUBLIC QUERIESProf. Dr. C.L. Mulder
- CONTACT for SCIENTIFIC QUERIESProf. Dr. C.L. Mulder
- Sponsor/Initiator Erasmus Medical Center, Department of Psychiatry
- Funding
(Source(s) of Monetary or Material Support)
ZON-MW, The Netherlands Organization for Health Research and Development, ACE Pharmaceuticals
- Publications-
- Brief summaryThe 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.
- Main changes (audit trail)
- RECORD28-dec-2016 - 19-mei-2017


  • Indien u gegevens wilt toevoegen of veranderen, kunt u een mail sturen naar nederlands@trialregister.nl