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Dose reduction or switch to ziprasidone followed by clozapine therapy: what works better in a long stay schizophrenia group?


- candidate number24369
- NTR NumberNTR5864
- ISRCTNISRCTN no longer applicable
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR18-mei-2016
- Secondary IDsP02.1663L CCMO
- Public TitleDose reduction or switch to ziprasidone followed by clozapine therapy: what works better in a long stay schizophrenia group?
- Scientific TitleA Double Blind Study to Compare the Switch of Long-stay Stabilized Patients with Schizophrenia or Schizoaffective Disorder to Ziprasidone with Low-Dose Conventional Antipsychotics; followed by an open, prospective study to compare ziprasidone to clozapine.
- ACRONYMAP Project
- hypothesisPatients treated with ziprasidone reveal fewer negative symptoms on the PANSS negative symptoms sub-scale and/or better scores on the CGI therapeutic effects sub-scale (CGI-TE) than patients treated with low-dose conventional antipsychotics (5 mg/day haloperidol or equivalent doses). For patients not effectively treated in this regimen clozapine will be superior.
- Healt Condition(s) or Problem(s) studiedSchizoaffective disorder, Schizophrenia, Therapy resistent
- Inclusion criteria-DSM-IV diagnosis of schizophrenia or schizoaffective disorder, based on a SCID interview.
-Use of conventional antipsychotics, p.o. or i.m. (depot-preparations), and the patient consenting to use oral medication.
-Psychotic symptoms having been present during at least the past 2 years, more or less continuously, confirmed by information from the clinical file and the SCID interview.
-Stable symptomatology and no changes in medication during the last 3 months before inclusion.
-Able to comply with the study design.
-Both sexes.
-Age d18 years.
-In-patients.
-Judicially (R.M. = forced hospitalization) or voluntarily staying in the hospital (I.B.S. excluded).
-Written informed consent from patient and/or representative.
- Exclusion criteria-Patients using conventional antipsychotics > 5 mg/day haloperidol equivalents with well documented failures to reduce the dose, because of destabilization.
-Somatic diseases that pose a medical risk (decided by the treating physician); decision based on the known physical condition, information from patient and physician, lab-results (from at least within one year before inclusion: BSE/CRE, blood cells, electrolytes, liver and kidney functions and glucose), a known QTc>500ms (ECG).
-Poor compliance with oral medication.
-patients under I.B.S. (forced hospitalization in crisis for a short time (max 3 weeks))
- mec approval receivedyes
- multicenter trialno
- randomisedyes
- masking/blindingDouble
- controlActive
- groupParallel
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 1-jul-2007
- planned closingdate
- Target number of participants100
- InterventionsThe study consists of three consecutive phases: 12-week pre-switch observation phase (Phase A): during 12 weeks repeated baseline ratings will be done under fixed medication schedules without change of previously used medication (stable baseline measurements).
Dose adjustment and switch phase (Phase B): At random one group of patients (group 1) continues to use conventional antipsychotics. The other group (group 2) is switched to ziprasidone. In group 1 doses of >5mg/day haloperidol equivalents will be reduced to 5 mg/day. Reduction will take a maximum of 24 weeks. Type of antipsychotic and route of administration will not be changed. In group 2, the equivalent of 5 mg/day of haloperidol of the conventional antipsychotic will be replaced by ziprasidone in the first 6 weeks of the double blind treatment phase. The remaining dose of the conventional antipsychotic is reduced similar to group 1. One-year treatment and observation phase (Phase C): after the dose adjustment and switch phase patients are treated and observed for 52 weeks.
Afterwards patients are treated with clozapine and followed for another year, with evaluations 12 weeks after an adequate plasma level and at the end of the study.
- Primary outcome PANSS negative symptoms scale
CGI therapeutic effect scale
- Secondary outcome Number of responders
NPO (neurocognitive functioning) : see addendum to the protocol
EPS (side effects: extra pyramidal): see addendum to the protocol
PANSS positive symptoms scale, general psychopathology scale and total scale
CGI severity of illness scale, global improvement scale
MADRS (symptoms of depression)
REHAB (general functioning)
SDAS (social dysfunction and aggression)
UKU (side effects)
SWN (subjective well-being)
Lancashire (quality of life)
Anticholinergic medication
Escape- and prn.- medication
- TimepointsBaseline measurements (Phase A): weeks 0, 6 and 12. Dose adjustment and switch phase (Phase B): variable, between 0 and 24 weeks following baseline time points. One-year treatment and observation phase (Phase C): weeks 4, 16, 34 and 52, following dose adjustment and switch phase.
Afterwards patients are treated with clozapine and followed for another year, with evaluations 12 weeks after an adequate plasma level and at the end of the study.

Measurements: symptoms of psychosis (PANSS), clinical impression of symptoms (CGI), depression (MADRS), neurocognitive symptoms (NPO), general functioning (REHAB), social function and aggression (SDAS), extrapyramidal and general side effects (AIMS, Fahn-Marsden, UPDRS, BARS and UKU), subjective well being (SWN), quality of life (MANSA), addiction severity (ASI), weight, length and laboratory measurements.
- Trial web site
- statusopen: patient inclusion
- CONTACT FOR PUBLIC QUERIESM.D., M.Sc. Jan Bogers
- CONTACT for SCIENTIFIC QUERIESM.D., M.Sc. Jan Bogers
- Sponsor/Initiator Mental Health Service Rivierduinen, University Medical Center Utrecht (UMCU)
- Funding
(Source(s) of Monetary or Material Support)
Pfizer, Mental Health Service Rivierduinen
- Publications
- Brief summary
- Main changes (audit trail)
- RECORD18-mei-2016 - 2-jul-2016


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