Overview

A Study to Evaluate Treatment Adherence in Schizophrenia With Long Acting Risperidone Microspheres (e-STAR)

Status:
Completed
Trial end date:
2009-06-01
Target enrollment:
0
Participant gender:
All
Summary
This study is a non-interventional web based registry designed to assess demographic, treatment and outcomes data in patients receiving treatment with long-acting injectable risperidone. One year retrospective data and 2 year prospective data will be collected.
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Janssen Korea, Ltd., Korea
Treatments:
Risperidone
Criteria
Inclusion Criteria:

- Patients starting treatment with a new antipsychotic medication

- Permitted by their physician to participate in a clinical trial

- Patients with schizophrenia or schizoaffective disorder

- Patients who are an ambulant or not chronically hospitalized for maximal 6 months at
the moment of initiation of study

- Patients and/or his/her relative, guardian or legal representative has signed the
informed consent form

Exclusion Criteria:

- First antipsychotic treatment ever

- Participating in any other drug study

- Chronically hospitalized and according to physician no possibility of being discharged
within the planned observation period

- On clozapine during the last 3 months

- Serious unstable medical condition, including recent and present clinically relevant
laboratory abnormalities

- Previous sensitivity history to risperidone and treatment resistant schizophrenia

- Pregnant or breast-feeding female

- Female with planned pregnancy within two years