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

Phase 3
Withdrawn
Conditions
Psychotic disorder
10039628
Registration Number
NL-OMON44089
Lead Sponsor
Erasmus MC, Universitair Medisch Centrum Rotterdam
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Withdrawn
Sex
Not specified
Target Recruitment
180
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

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 somatic medical condition
4.insufficient proficiency in Dutch language
5.women who are pregnant
6. patient is on adequate antipsychotic therapy

Study & Design

Study Type
Interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Secondary Outcome Measures
NameTimeMethod
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