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
Condition: Schizophrenia; Psychotic Disorders
MeSH terms: Schizophrenia; Psychotic Disorders
Study type: Interventional
Phase: Phase 3

Summary: 
      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.
    

Detailed 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.
    

Intervention name(s): risperidone
Intervention type(s): Drug
Intervention MeSH terms: Risperidone
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Schizophrenia; schizoaffective disorder; patient compliance; long-acting risperidone; intramuscular injection; Treatment Guidebook