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, Patients with schizophrenia, aged 18 years or older, having experienced the first psychosis 0.5 - 7 years ago, with an indication (patient or physician initiated) to receive medication or to switch to another antipsychotic drug, can 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 can be asked to provide consent and participate in a naturalistic follow-up cohort: this
non-interventional observational cohort is implemented to assess ecological validity of the main study.
Estimated Enrollment: 600
Study start date: February 2015
Estimated study completion date: October 2019