Schizophrenia Clinical Trial
Official title:
European Long-acting Antipsychotics in Schizophrenia Trial
Schizophrenia is a chronic psychiatric illness with periods of remission and relapse. Patients vary in the frequency and severity of relapse, time until relapse and time in remission. Discontinuation of antipsychotic medication is by far the most important reason for relapse. A possible method to optimize medication adherence is to treat patients with long-term, depot medication rather than oral medication. However, despite its apparent "common sense" this approach has neither been universally accepted by practicing psychiatrists nor unequivocally demonstrated in clinical trials. Therefore, in this study we aim to investigate possible advantages of depot medication over oral antipsychotics in an independently designed and conducted, randomized, pragmatic trial.
It remains unclear if depot medication can reduce relapse rates and improve clinical outcome
when offered to all patients in need of continuation treatment with antipsychotics. Before we
can conclude whether or not all schizophrenia patients could benefit from a switch to depot
formulations, several questions remain to be answered. Is depot medication associated with
better continuation rates and outcome? How are depot medications tolerated as compared to
oral medication? In order to clarify these important issues we aim to perform a large
multi-center trial in which schizophrenia patients in need of continuous treatment who are
randomized 1:1:1:1 to two different depot preparations or to two different oral medications.
In this pragmatic, randomized, open label, multicenter, multinational comparative trial,
schizophrenic patients aged 18 years or older, having experienced the first psychosis between
6 months and 7 years ago,with an indication (patient or physician initiated) to receive
medication or to switch to another antipsychotic drug, will enter the study.
The study duration will be one month for the medication switch and then a follow-up of 18
months. Patients having refused to take part in the study will be asked to give consent and
participate in a naturalistic follow-up, during which they will be followed with the Clinical
Global Impression list (CGI) as closely related to the study schedule as possible, unless
they also refuse this.
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