Phenomics and Genomics of Clozapine Pharmacotherapy

Withdrawn

Conditions: psychosis
psychotic disorders
10039628

Registration Number: NL-OMON42072

Lead Sponsor: niversitair Medisch Centrum Utrecht

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Withdrawn

Sex: Not specified

Target Recruitment: 4000

Inclusion Criteria

-he/she currently uses clozapine or is about to initiate a treatment of clozapine
-he/she has received a diagnosis of schizophrenia or schizoaffective disorder, either clinician-rated based on DSM-IV or 5 criteria or according to a (semi-)structured interview
-his/her age must be >=18 years old
-he/she must be able to speak and read the Dutch language
-he/she must understand the information provided about the study and express a willingness to participate

Exclusion Criteria

- admission to a psychiatric unit involuntarily in the context of an *inbewaringstelling* (IBS) or *rechterlijke machtiging* (RM)

Study & Design

Study Type: Observational non invasive

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>In a discovery cohort a case-control genome-wide association study (GWAS) will<br /><br>be performed on 2000 clozapine using subjects (cases) and >30,000 already<br /><br>available SCZ patients (controls, drawn from the most recent Psychiatric<br /><br>Genomics Consortium analysis, http://www.med.unc.edu/pgc/downloads). We hereby<br /><br>aim to reveal potential differences in the genetic architecture between the<br /><br>severe CLZ-SCZ phenotype and the broad SCZ phenotype. This analysis will be<br /><br>compounded by polygenic risk score analyses determining explained variances by<br /><br>risk loci at predefined p-value association cut-offs of 10-7, 10-6, 10-5, 10-4,<br /><br>10-3, 10-2, 0.05, 0.1 and 0.5 between the CLZ-SCZ phenotype and the broad SCZ<br /><br>phenotype.</p><br>

Secondary Outcome Measures