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

Effectiveness of penfluridol (oral long acting neuroleptic) as compared to second generation oral neuroleptics in psychotic disorder patients: an open label randomized controlled trial. - The One for Seven Study

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2014-003834-21-NL

Enrollment

180

Registered

2015-04-01

Start date

2016-09-23

Completion date

Unknown

Last updated

2018-01-29

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

Conditions

Psychotic disorders

Interventions

Trade Name: Zyprexa Product Name: olanzapine Pharmaceutical Form: Coated tablet Trade Name: risperidon Product Name: risperdal Pharmaceutical Form: Coated tablet Product Name: penfluridol Pharmaceut

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: In order to be eligible to participate in this study, a subject must meet all of the following 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 (at the start of the study) 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 a no decisive contra-indications 5. patient is willing to use oral neuroleptic treatment, including penfluridol, olanzapine or risperidone 6. able to give informed consent Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 180 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: A potential subject who meets any of the following criteria will be excluded from participation in this study: 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

Design outcomes

Primary

Measure	Time frame
Main Objective: The primary objective of this study is to determine the time to all-cause medication discontinuation of penfluridol (acemap; oral long acting neuroleptic) as compared to second-generation oral neuroleptics (olanzapine, risperidone) using an open label randomized controlled trial design in 180 patients. ;Secondary Objective: Secondary objectives include the reason for treatment discontinuation, efficacy, safety and tolerability, drug attitude, subjective well-being, insight, healthcare related costs and quality of life.;Primary end point(s): Primary endpoint of the study will be time to all-cause discontinuation, calculated from the date of randomization to the date of medication discontinuation according to the discontinuation definition.;Timepoint(s) of evaluation of this end point: After 52 weeks	—

Measure

Time frame

Main Objective: The primary objective of this study is to determine the time to all-cause medication discontinuation of penfluridol (acemap; oral long acting neuroleptic) as compared to second-generation oral neuroleptics (olanzapine, risperidone) using an open label randomized controlled trial design in 180 patients. ;Secondary Objective: Secondary objectives include the reason for treatment discontinuation, efficacy, safety and tolerability, drug attitude, subjective well-being, insight, healthcare related costs and quality of life.;Primary end point(s): Primary endpoint of the study will be time to all-cause discontinuation, calculated from the date of randomization to the date of medication discontinuation according to the discontinuation definition.;Timepoint(s) of evaluation of this end point: After 52 weeks

—

Secondary

Measure	Time frame
Secondary end point(s): Secondary endpoints include the reason for treatment discontinuation, and relationship between efficacy, safety and tolerability, drug attitude, subjective well-being, insight and compliance, healthcare related costs and quality of life.;Timepoint(s) of evaluation of this end point: After 52 weeks	—

Countries

Netherlands

Contacts

Public ContactJanneke Gilden

Erasmus Medical Center Rotterdam

j.gilden@erasmusmc.nl

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026