Study Stopped
Inability to recruit number of planned patients
A Study of Risperidone Long-Acting Injection Versus Oral Antipsychotics in Schizophrenia Participants With a History of Being Poorly Compliant With Taking Their Medication
Pragmatic Randomized Trial of Risperdal Consta Versus Oral Atypical Antipsychotics in Poorly Adherent Subjects With Schizophrenia in a Routine Care Setting
2 other identifiers
interventional
167
4 countries
44
Brief Summary
The purpose of this study is to evaluate risperidone long-acting injection (an antipsychotic medication) versus oral antipsychotics in schizophrenia (psychiatric disorder with symptoms of emotional instability, detachment from reality, often with delusions and hallucinations, and withdrawal into the self) participants with a history of being poorly compliant with taking their medication.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_4 schizophrenia
Started Jan 2006
Typical duration for phase_4 schizophrenia
44 active sites
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
First Submitted
Initial submission to the registry
November 18, 2005
CompletedFirst Posted
Study publicly available on registry
November 22, 2005
CompletedStudy Start
First participant enrolled
January 1, 2006
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2009
CompletedResults Posted
Study results publicly available
October 7, 2013
CompletedDecember 5, 2013
November 1, 2013
3.2 years
November 18, 2005
February 27, 2013
November 12, 2013
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Percentage of Participants Who Experienced a Clinical Exacerbation From Month 3 Post-Randomization
Clinical exacerbation is defined as hospitalization because of participant's schizophrenia (psychiatric disorder with symptoms of emotional instability, detachment from reality, delusions, hallucinations, and self withdrawal) or requiring change from current antipsychotic or initiation of adjunctive antipsychotic, 2-point worsening in Clinical Global Impression of Severity (CGI-S) or emergency room visit, deliberate self-injury, emergence of clinically significant suicidal ideation, utilization of treatment team services, violent behavior, requiring an increase in dose of existing antipsychotic as a result of poor symptom control.
Month 3 up to Month 24
Secondary Outcomes (9)
Percentage of Participants Who Experienced a Clinical Exacerbation
Baseline up to Month 24
Time to First Clinical Exacerbation
Baseline up to Month 24
Time in Symptomatic (Having Symptoms) Remission
Baseline up to Month 24
Change From Baseline in Positive and Negative Syndrome Scale (PANSS) - Total Score at Month 24
Baseline and Month 24
Number of Participants With Clinical Global Impression of Severity (CGI-S)
Baseline and End of Study (Month 24 or Early Withdrawal [EW])
- +4 more secondary outcomes
Study Arms (2)
Risperidone long-acting injection (LAI)
EXPERIMENTALRisperidone LAI 25 milligram (mg), 37.5 mg or 50 mg intramuscular (injection of a substance into a muscle) injection will be administered every 2 weeks as per Investigator's discretion. An oral atypical antipsychotic will also be administered in the first 3 weeks following the dose increase. Duration of treatment will be 24 months.
Oral atypical Antipsychotic
ACTIVE COMPARATOROral atypical antipsychotic will be administered as per local label practice for 24 months. Participants will be switched to another atypical oral therapy as per Investigator's discretion.
Interventions
Risperidone LAI 25 milligram (mg), 37.5 mg or 50 mg intramuscular (injection of a substance into a muscle) injection will be administered every 2 weeks as per Investigator's discretion. An oral atypical antipsychotic will also be administered in the first 3 weeks following the dose increase. Duration of treatment will be 24 months.
Oral atypical antipsychotic will be administered as per local label practice for 24 months. Participants will be switched to another atypical oral therapy as per Investigator's discretion.
Eligibility Criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (44)
Unknown Facility
Dandenong, Australia
Unknown Facility
Frankston, Australia
Unknown Facility
Mount Claremont, Australia
Unknown Facility
Newcastle, Australia
Unknown Facility
Southport, Australia
Unknown Facility
Calgary, Alberta, Canada
Unknown Facility
Bathurst, New Brunswick, Canada
Unknown Facility
Kentville, Nova Scotia, Canada
Unknown Facility
Sydney, Nova Scotia, Canada
Unknown Facility
Greater Sudbury, Ontario, Canada
Unknown Facility
Kingston, Ontario, Canada
Unknown Facility
Mississauga, Ontario, Canada
Unknown Facility
Beauport, Quebec, Canada
Unknown Facility
Montreal, Quebec, Canada
Unknown Facility
Québec, Quebec, Canada
Unknown Facility
Saint-Georges, Quebec, Canada
Unknown Facility
Battleford, Saskatchewan, Canada
Unknown Facility
Prince Albert, Saskatchewan, Canada
Unknown Facility
Montreal, Canada
Unknown Facility
Saint John, Canada
Unknown Facility
Co.Mayo, Ireland
Unknown Facility
Dublin, Ireland
Unknown Facility
Mullingar, Ireland
Unknown Facility
Birmingham, United Kingdom
Unknown Facility
Boston, United Kingdom
Unknown Facility
Bristol, United Kingdom
Unknown Facility
Burnley, United Kingdom
Unknown Facility
Darwen, United Kingdom
Unknown Facility
Devon, United Kingdom
Unknown Facility
Grantham, United Kingdom
Unknown Facility
Leicester, United Kingdom
Unknown Facility
Lincoln, United Kingdom
Unknown Facility
London, United Kingdom
Unknown Facility
Morpeth, United Kingdom
Unknown Facility
Newcastle upon Tyne, United Kingdom
Unknown Facility
Northampton, United Kingdom
Unknown Facility
Nottingham, United Kingdom
Unknown Facility
Preston, United Kingdom
Unknown Facility
Stamford, United Kingdom
Unknown Facility
Stockton-Upon-Tees, United Kingdom
Unknown Facility
Swansea, United Kingdom
Unknown Facility
Teignmouth, United Kingdom
Unknown Facility
Wallsend, United Kingdom
Unknown Facility
Weston-super-Mare, United Kingdom
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Limitations and Caveats
The study was terminated due to futility.
Results Point of Contact
- Title
- Director Medical Affairs - CNS
- Organization
- Janssen Inc. Toronto, Ontario, Canada
Study Officials
- STUDY DIRECTOR
Janssen Inc. Clinical Trial
Janssen Inc.
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- LTE60
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 18, 2005
First Posted
November 22, 2005
Study Start
January 1, 2006
Primary Completion
April 1, 2009
Study Completion
April 1, 2009
Last Updated
December 5, 2013
Results First Posted
October 7, 2013
Record last verified: 2013-11