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
Information source: Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Schizophrenia; Psychotic Disorders
Intervention: risperidone (Drug)
Phase: Phase 3
Status: Completed
Sponsored by: Johnson & Johnson Pharmaceutical Research & Development, L.L.C. Official(s) and/or principal investigator(s): Johnson & Johnson Pharmaceutical Research & Development, L.L. C. Clinical Trial, Study Director, Affiliation: Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
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.
Clinical Details
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
Study design: Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: Usefulness of the Risperdal® Consta® Treatment Guidebook; patient and clinician adherence to guidelines
Secondary outcome: 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
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.
Eligibility
Minimum age: 18 Years.
Maximum age: 65 Years.
Gender(s): Both.
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.
Locations and Contacts
Additional Information
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
Last updated: May 17, 2011
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