NCT03130465

Aripiprazole Once-monthly Versus Daily Oral Atypical Antipsychotic Treatment in Patients With Recent-onset Schizophrenia

Aripiprazole Once-monthly Versus Daily Oral Atypical Antipsychotic Treatment in Patients With Recent-onset Schizophrenia: an Observational, Non-interventional Study

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 636 (estimated)
• Sponsor: Otsuka Pharmaceutical Europe Ltd · Industry
• Sex: All
• Age: 18 Years – 35 Years
• Healthy volunteers: Not accepted

Summary

This is an observational, non-interventional study that will include two cohorts of patients with schizophrenia who initiated maintenance treatment during a schizophrenia-related hospitalisation or during the immediate three months after hospital discharge: patients who initiated maintenance treatment with AOM and patients who initiated maintenance treatment with any daily oral atypical AP.

Detailed description

This is an observational, non-interventional study that will include two cohorts of patients with schizophrenia who initiated maintenance treatment during a schizophrenia-related hospitalisation or during the immediate three months after hospital discharge: patients who initiated maintenance treatment with AOM and patients who initiated maintenance treatment with any daily oral atypical AP. The date of maintenance treatment initiation will be considered the index date (see definition of maintenance treatment initiation in Section 3.1). Baseline data will be collected immediately after the inclusion of the patient in the study (including retrospective data from the index date to the date of informed consent and from the past 5 years). From the index date, each patient will be followed up until discontinuation of the maintenance treatment of interest and up to a maximum of 12 months. Especially after the implementation of the Global Amendment nº1, it is possible that the complete follow-up of the patient took place in the past (retrospective data), i.e. before the inclusion of the subject in the study. Data will be collected from the patient file and from information obtained during routine visits scheduled according to clinical practice.

Conditions

• Schizophrenia

Timeline

• Start date: 2017-07-13
• Primary completion: 2020-01-31
• Completion: 2020-01-31
• First posted: 2017-04-26
• Last updated: 2019-04-11

Locations

67 sites across 4 countries: France, Germany, Italy, Spain