drugset / Trial / NCT02146547

European Long-acting Antipsychotics in Schizophrenia Trial

NCT02146547

Phase 4 Completed 536 enrolled UMC Utrecht
RandomizedParallel-groupOpen-labelTreatment

Summary

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.

Timeline

Start
2015-02
Primary completion
2020-08-26
Completion
2020-08-26

Drugs

EvaluationDrugModalityDoseRoute
Comparator Aripiprazole Other / unclassified 15 mg Oral
Comparator Aripiprazole Other / unclassified 400 mg Intramuscular
Comparator Paliperidone Unknown 6 mg Oral
Comparator Paliperidone Unknown 75 mg Intramuscular

Indications