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
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
1 other identifier
interventional
1
0 countries
N/A
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_3 schizophrenia
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Completion
Last participant's last visit for all outcomes
January 1, 2003
CompletedFirst Submitted
Initial submission to the registry
October 7, 2005
CompletedFirst Posted
Study publicly available on registry
October 12, 2005
CompletedMay 18, 2011
March 1, 2011
October 7, 2005
May 17, 2011
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Usefulness of the Risperdal® Consta® Treatment Guidebook; patient and clinician adherence to guidelines
Secondary Outcomes (1)
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
Interventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Johnson & Johnson Pharmaceutical Research & Development, L.L. C. Clinical Trial
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
October 7, 2005
First Posted
October 12, 2005
Study Completion
January 1, 2003
Last Updated
May 18, 2011
Record last verified: 2011-03