therapy refractory schizophrenia and schizoaffective disorders
Conditions
Interventions
The 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 o
Sponsors
Mental Health Service Rivierduinen;
University Medical Center Utrecht
Eligibility
Inclusion criteria
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
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))
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| •PANSS negative symptoms scale •CGI therapeutic effect scale | — |
Secondary
| Measure | Time frame |
|---|---|
| • 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 | — |
Contacts
Public ContactJan Bogers
Valklaan 3
Outcome results
None listed