Evaluation of the Usefulness to Doctors of the Risperdal Consta Treatment Guidebook Over a Three-month Period During Which Adult Patients With Schizophrenia or Schizoaffective Disorder Are Switching From Daily Doses or Risperidone Tablets to Long-acting Risperidone by Injection

Johnson & Johnson (J&J)

Status and phase

Completed

Phase 3

Conditions

Psychotic Disorders

Schizophrenia

Treatments

Drug: risperidone

Study type

Interventional

Funder types

Industry

Identifiers

NCT00236548

CR002896

Details and patient eligibility

About

The purpose of this study is to assess the usefulness of the RisperdalÂ® ConstaÂ® Treatment Guidebook in helping the doctor switch the adult patient from taking risperidone tablets daily by mouth to taking long-acting risperidone by injection. The study will also evaluate the effectiveness and safety of long-acting risperidone and its effect on patient satisfaction.

Full description

Many patients who take oral medication to treat schizophrenia or schizoaffective disorder have trouble taking their medication every day. They may not want to take it, or they may just forget. Risperidone injections, given once every 2 weeks, are expected to be just as effective as risperidone tablets taken once a day. The option of getting an injection every 2 weeks rather than taking a tablet every day may help patients keep to their medication administration schedule and could help to reduce the symptoms of their disease. The study will assess the usefulness of the Risperdal® Consta® Treatment Guidebook in a Community Mental Health Center setting, over a period of three months. This Guidebook was designed to help doctors switch adult patients from oral risperidone tablets to long-acting risperidone given once every 2 weeks by injection. During the study, patients will continue to take oral risperidone for 2 weeks following initiation of risperidone injections, which will be given every 2 weeks during a 12-week period. Physical examinations and laboratory tests will be performed to test the safety of the risperidone injections. Both the patient and the doctor will be asked questions about the usefulness of the guidebook and the effectiveness of the injections. The objective of this study is to demonstrate the effectiveness of the Risperdal® Consta™ Treatment Guidebook in switching patients with schizophrenia and schizoaffective disorder from daily oral risperidone to long-acting risperidone injections. In addition, safety evaluations are assessed throughout the study. Risperidone oral tablets, 2 to 6 milligrams per day for the first 2 weeks after initiation of long-acting risperidone injections; long-acting risperidone injections are given in doses of 25, 37.5, or 50 milligrams per 2 milliliter injection once every 2 weeks for 12 weeks.

Enrollment

1 patient

Sex

All

Ages

18 to 65 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Diagnosis of schizophrenia or schizoaffective disorder
stable with respect to disease symptoms and other medical conditions
taking oral risperidone at doses of 2 to 6 milligrams per day for 4 weeks before start of study
if female, using birth control.

Exclusion criteria

Hospitalized within past 4 weeks to treat exacerbation of symptoms of schizophrenia
at risk for injury to self or others
had electroconvulsive therapy within past year
presence of liver or kidney impairment
use of oral antipsychotics (other than risperidone) within past 4 weeks, of injected antipsychotics within past 3 months, of clozapine within past 60 days, or of long-acting risperidone in an earlier study
pregnant or breast-feeding
not using birth control
abusing drugs or alcohol.