A 2-year Study of Patients With Schizophrenia Who Are Treated With Long-acting Injectable Risperidone.

Janssen (J&J Innovative Medicine)

Status and phase

Completed

Phase 4

Conditions

Schizophrenia

Treatments

Behavioral: GAIN Acceptance Approach

Study type

Interventional

Funder types

Industry

Identifiers

NCT00261430

CR002893

Details and patient eligibility

About

The purpose of this study is to examine treatment practices of adult schizophrenia patients by their own doctors, and to assess patient outcomes when treated with long-acting risperidone injection over a two-year period of observation.

Full description

Controlled clinical trials for treating schizophrenia often involve selected patients with common characteristics. It is recognized that schizophrenia are much more diverse than those in the clinical setting, and that physician's prescribing practices may vary. The objective of the study is to examine treatment practices for adult schizophrenic patients by their own physicians, and to assess patient outcomes when treated with long-acting risperidone injection. This is a 2-year, prospective, multi-center, longitudinal, observational study in adults with schizophrenia. Physicians will determine the appropriate treatment for their patients, according to their usual practice. Patients starting treatment with long-acting risperidone injections and meeting all the study criteria may enroll in the study. Patients will continue their treatment according to usual care by their physicians. Patients will be asked questions at baseline and every three months for a period of two years to assess: efficacy of the medication, how well the patient is functioning, use of healthcare resources (e.g., emergency room visits, hospitalizations) patient work status, quality of life and patient satisfaction with the medicine. Safety will be monitored throughout the study. A dose of 25, 37.5 or 50 mg of risperidone, administered every 2 weeks by intramuscular injection.

Enrollment

650 patients

Sex

All

Ages

18 to 70 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Diagnosis of schizophrenia
long-term use of antipsychotic medication and taking any oral antipsychotic for 4 weeks before the study
stable with respect to disease symptoms and other medical conditions
if female, using birth control.

Exclusion criteria

At risk to self or others
use of injectable antipsychotics within the past 6 months, of clozapine, or of investigational drugs within 30 days
considered to be resistant to treatment
pregnant or breast-feeding
not using birth control.