Official Title: “An Open-Label Evaluation of the Utility of the RISPERDAL® CONSTA® Treatment Guidebook During Transition of Adult Patients With Schizophrenia or Schizoaffective Disorder to RISPERDAL® CONSTA® (Risperidone) Treatment Over Three Months in the Community Mental Health Center (CMHC) Setting”

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.

Study Type: Interventional

Study Design: Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Efficacy Study

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.

Intervention(s) in this Clinical Trial

• Drug: risperidone

Primary Measures

• Usefulness of the Risperdal® Consta® Treatment Guidebook; patient and clinician adherence to guidelines

Secondary Measures

• Effectiveness of study drug measured by the Clinical Global Impression scale; safety by assessing treatment-emergent adverse events, vital signs, laboratory tests or electrocardiogram changes; quality of life by the Schizophrenia Quality of Life Scale

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

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: 65 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

Overall Clinical Trial Officials and Contacts

Johnson & Johnson Pharmaceutical Research and Development, L.L.C. Clinical Trial Study Director Johnson & Johnson Pharmaceutical Research & Development, L.L.C.  

Information obtained from ClinicalTrials.gov on February 04, 2010

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00236548

Study ID Number: CR002896

ClinicalTrials.gov Identifier: NCT00236548

Health Authority: United States: Food and Drug Administration

An open-label evaluation of the RISPERDAL® CONSTA® Treatment Guidebook during transition of adult patients with schizophrenia or schizoaffective disorder to RISPERDAL® CONSTA® over 3 months in the Community Mental Health Center (CMHC) setting