Clozapine in Daily Life: an Experience Sampling Pilot Study

Recruiting

Conditions: psychosis
schizophrenia
10039628
10024450

Registration Number: NL-OMON35815

Lead Sponsor: Academisch Medisch Centrum

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Recruiting

Sex: Not specified

Target Recruitment: 30

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

Study & Design

Study Type: Observational non invasive

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Changes in positive and negative affect will be measured by Experience Sampling<br /><br>Method with the PsyMate. Changes in psychopathology and global functioning will<br /><br>be measured with the PANSS, CGI and GAF. Subjective experience during last week<br /><br>will be measured with the SWN questionnaire. Side-effects will be measured by<br /><br>GASS.</p><br>

Secondary Outcome Measures