Overview

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-ac

Status:
Completed
Trial end date:
2003-01-01
Target enrollment:
0
Participant gender:
All
Summary
The purpose of this study is to assess the usefulness of the Risperdal® Consta® 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.
Phase:
Phase 3
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Collaborator:
Janssen, LP
Treatments:
Risperidone
Criteria
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.