Evaluation of the Efficacy and Safety of Risperidone Injections Given Once a Month to Adults With Schizophrenia or Schizoaffective Disorder
An Open-label Study of the Efficacy and Safety of RISPERDAL Long-acting Microspheres (RISPERDAL CONSTA) Administered Once Monthly in Adults With Schizophrenia or Schizoaffective Disorder
1 other identifier
interventional
86
0 countries
N/A
Brief Summary
The purpose of this study is to assess the effectiveness and safety of long-acting risperidone given as a once monthly injection to adult patients with schizophrenia or schizoaffective disorder.
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
Started May 2002
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2002
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2003
CompletedFirst Submitted
Initial submission to the registry
October 7, 2005
CompletedFirst Posted
Study publicly available on registry
October 12, 2005
CompletedMay 17, 2011
March 1, 2011
October 7, 2005
May 16, 2011
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Effectiveness measured by incidence of symptom reoccurrence (relapse) in 1 year.
Secondary Outcomes (1)
Effectiveness assessed by the Clinical Global Impression Scale, Positive and Negative Syndrome Scale; safety scales are for: Extrapyramidal Symptom Rating, Abnormal Involuntary Movement, and Dickson-Glazer Sexual Functioning Inventory, and adverse events
Interventions
Eligibility Criteria
You may qualify if:
- Diagnosis of schizophrenia or schizoaffective disorder
- stable with respect to disease symptoms and other medical conditions
- stable on antipsychotic therapy with oral risperidone 2 to 6 milligrams per day for 8 weeks before study
- if female, using birth control.
You may not qualify if:
- Hospitalized within 8 weeks of beginning the study
- at risk to self or others
- presence of liver or kidney damage
- use of oral antipsychotic drugs other than risperidone within the past 8 weeks, of injected antipsychotics within the past 6 months, of long-acting risperidone in an earlier study, of investigational drugs within the past 30 days, or of electroconvulsive therapy within the past 12 months
- pregnant or breast-feeding
- if female, not using birth control
- abusing drugs or alcohol.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Janssen, LPlead
Related Publications (1)
Uchida H, Mamo DC, Kapur S, Labelle A, Shammi C, Mannaert EJ, Mann SW, Remington G. Monthly administration of long-acting injectable risperidone and striatal dopamine D2 receptor occupancy for the management of schizophrenia. J Clin Psychiatry. 2008 Aug;69(8):1281-6. doi: 10.4088/jcp.v69n0811.
PMID: 18642974DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Janssen, LP Clinical Trial
Janssen, LP
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 Start
May 1, 2002
Study Completion
December 1, 2003
Last Updated
May 17, 2011
Record last verified: 2011-03