To determine whether changes in affect of patients with schizophrenia occur after starting clozapine.
ID
Source
Brief title
Condition
- Schizophrenia and other psychotic disorders
- Lifestyle issues
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
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 outcome
-
Background summary
Subjective experience of patients during use of antipsychotics is highly
relevant for the course of the disorder. Because of its unique binding affinity
to dopaminergic receptors clozapine might have a favourable effect on affect.
The Experience Sampling Method (ESM) is a valid method to assess reactivity to
stress in daily life. Research with ESM after medication switch is sparse and
yet clinically very relevant.
Study objective
To determine whether changes in affect of patients with schizophrenia occur
after starting clozapine.
Study design
an open longitudinal study
Study burden and risks
Patients may benefit from participation in this study because it may give them
insight into their symptoms and possible side-effects. No risks are involved in
this study.
Meibergdreef 5
1105 AZ Amsterdam
NL
Meibergdreef 5
1105 AZ Amsterdam
NL
Listed location countries
Age
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
- 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
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL36202.018.11 |