psychosis schizophrenia
Conditions
Interventions
None listed
Sponsors
Academisch Medisch Centrum
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: Eligible for the study are in- and outpatients age 18 to 60, meeting DSM-IV criteria for schizophrenia, schizoaffective or schizophreniform disorder starting treatment with clozapine. Patients that are admitted under authority of the court should also be included, since this group embodies a part of the target group. Patients should be able to understand the study information and procedures and give informed consent.
Exclusion criteria
Exclusion criteria: - Pregnancy - Lactating women - Female subject without adequate contraception - Known hypersensitivity to clozapine or ingredients used in these tablets - Narrow-angle glaucoma - Known neurological or endocrine disease interfering with clozapine treatment - Myeloproliferative disorder - Uncontrolled epilepsy - Paralytic ileus - Current leukocyte level lower than 3.5 x 109/l - Current neutrophilic granulocyte level lower than 2.0x 109/l -Use of: fluvoxamine, carbamazepine, coumarine derivates, cimetidine, ciprofloxacine, erythromycine, citalopram and cytostatica
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Changes in positive and negative affect will be measured by Experience Sampling Method with the PsyMate. Changes in psychopathology and global functioning will be measured with the PANSS, CGI and GAF. Subjective experience during last week will be measured with the SWN questionnaire. Side-effects will be measured by GASS. | — |
Secondary
| Measure | Time frame |
|---|---|
| - | — |
Countries
Netherlands
Outcome results
None listed