New clozapine users (English)

This study (CLOZIN) looks at clozapine treatment in psychotic disorders. These include schizophrenia, schizophreniform disorder, schizoaffective disorder and psychotic disorders not otherwise specified (NOS). The hearing of voices, for example, is common in these disorders. For treating this disorder, clozapine is prescribed when other antipsychotic medication did not have sufficient effect. As this is quite late in the disease, we want to create a tool to predict respone and side effects. This is done by means of a 3 visits during which we take a blood sample and conduct a questionnaire. With the use of blood sampling, the DNA can be investigated.

What kind of patients are we looking for?
To create the prediction tool, 300 patients with mental disorders are required. We are looking for people who:
1) Are diagnosed with schizophrenia, schizoaffective, or schizophreniform disorder
2) Will use clozapine
3) Speak and read the language of the country of the participating center
4) Are able of making their own decision whether they want to participate in this research.
5) Are at least 18 years of age.

Patients cannot participate if:
1) They are institutionalized in a psychiatric facility under custody.
2) They have Parkinson’s disease.

What exactly is done during the visit?

For the CLOZIN study we collect 3 blood draws from participants (37.5 ml in total). We try to do this during your routine blood monitoring and usually it does not involve an additional puncture. In addition, a doctor or researcher will conduct a conversation about side effects. The study saves the data under a code, not under the participant’s name. We work in line with prinacy laws and Good Clinical Practice.

Every visit takes approximately 1 hour and 20 minutes. The visits take place before the start of clozapine treatment or in 10 days after starting, between 4 and 12 weeks after initiation, and 6 months after clozapine initiation. In total there are 3 visits.

Is participation voluntary?
Participation is completely voluntary. If someone decides not to participate, it is not necessary to explain why not. The decision does not affect the received care. If someone decides to participate, it is always possible to consider to withdraw permission at any time without having to tell why.

What do you get in return?
For participation in the research, the participant will receive € 15,- compensation (if allowed by local legislation). In addition, the participant contributes to the improvement of the treatment of psychoses.

What are the possible risks?
There is no risk of participation in this research. For example, there is usually no extra blood draw.

Who organizes the research?
CLOZIN was founded by a psychiatrist and neuroscientist Jurjen Luykx, working at the Brain Center Rudolf Magnus that is part of the University Medical Center Utrecht (UMCU). The study is coordinated by Marte van der Horst, MSc, working at the UMCU Psychiatry Department. The study sponsor was Prof. dr. René Kahn, UMCU, and is now made possible by GGNet.

Which centers participate in the research?
The CLOZIN research does not only take place in UMC Utrecht. There are several institutions that also contribute(d) to research. A recent overview can be found in the group.