Phenomics and Genomics of Clozapine Pharmacotherapy - New Clozapine Users

Recruiting

Conditions: Psychosis
psychotic disorders
10039628

Registration Number: NL-OMON50475

Lead Sponsor: niversitair Medisch Centrum Utrecht

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Recruiting

Sex: Not specified

Target Recruitment: 200

Inclusion Criteria

-he/she is about to initiate clozapine
-he/she has received a diagnosis of schizophrenia, schizophreniform,
schizoaffective disorder or psychosis not otherwise specified
(DSM-IV)/(un)specified other schizospectrum psychotic disorder
-he/she must be able to speak and read the Dutch language
- he/she must be 18 years or older
-he/she must understand the information provided about the study and understand
the consequences of participating and express a willingness to participate.
This estimation is done by the treating physician during the informed consent
procedure.

Exclusion Criteria

- admission to a psychiatric unit involuntarily in the context of an
*inbewaringstelling* (IBS)
- when the treating physician doubts if the patient understands the
information/consequences of participation or the willingness to participate
- Patients with Parkinson*s disease

Study & Design

Study Type: Observational non invasive

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Response to CLZ is measured using the Positive and Negative Syndrome Scale<br /><br>(PANSS) and the first two questions of the Clinical Global Impression (CGI).<br /><br>The results will be linked to changes in targeted methylation and gene<br /><br>expression. Furthermore, the presence of several Adverse Drug Reactions are<br /><br>assessed.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Secondary:<br /><br>1. To identify non-genetic predicting factors for treatment outcome after<br /><br>initiation of CLZ.<br /><br>2. To predict reponse and side effects<br /><br>3. To assess whether the genetic architecture of this severe SCZ phenotype<br /><br>differs from the broad DSM-based SCZ phenotype. <br /><br>4. To detect genetic associations within the current severe SCZ phenotype by<br /><br>performing a case control comparison with healthy participants. <br /><br>5. To investigate whether CLZ use increases or decreases the risk of<br /><br>cardiovascular disease and early death. <br /><br><br /><br> These goals are the main objectives in our other protocol entitled Phenomics<br /><br>and genomics of CLZ pharmacotherapy - current users. To make optimal use of<br /><br>patients* DNA and to increase power for that other study we will ask<br /><br>participants in the current study for informed consent to use their DNA for<br /><br>these objectives.</p><br>