Study to Measure Drug Satisfaction of Patients With Schizophrenia After Switching From Risperidone to Paliperidone
A Blinded-initiation Study of Medication Satisfaction in Subjects With Schizophrenia Treated With Paliperidone ER After Suboptimal Response to Oral Risperidone
2 other identifiers
interventional
201
6 countries
40
Brief Summary
The purpose of this study is to evaluate medication satisfaction after at least 4 weeks of paliperidone ER (extended-release), an antipsychotic, treatment in patients with schizophrenia who were previously taking either 4 or 6 mg of risperidone daily by mouth, but who are not satisfied with their treatment.
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 Oct 2007
Shorter than P25 for phase_4 schizophrenia
40 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
September 24, 2007
CompletedFirst Posted
Study publicly available on registry
September 26, 2007
CompletedStudy Start
First participant enrolled
October 1, 2007
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2008
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2008
CompletedResults Posted
Study results publicly available
October 20, 2009
CompletedMay 9, 2014
April 1, 2014
9 months
September 24, 2007
July 17, 2009
April 24, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Medication Satisfaction Questionnaire (MSQ) Score Change From Baseline to the Week 6 Endpoint.
The MSQ is a 7-point, verbally administered, Likert-type scale rated as follows: 1=Extremely Dissatisfied, 2=Very Dissatisfied, 3=Somewhat Dissatisfied, 4=Neither Satisfied Nor Dissatisfied, 5=Somewhat Satisfied, 6=Very Satisfied, 7=Extremely Satisfied. Worst value is 1 (Extremely Dissatisfied) and best value is 7 (Extremely Satisfied).
Change from Baseline in MSQ Score at Week 6 Last Observation Carried Forward (LOCF)
Secondary Outcomes (12)
Medication Satisfaction Questionnaire (MSQ) Score Change From Baseline to Week 2 (Observed).
Change from Baseline in MSQ Score at Week 2
Medication Satisfaction Questionnaire (MSQ) Score Change From Baseline to Week 4 (Observed).
Change from Baseline in MSQ Score at Week 4
Medication Satisfaction Questionnaire (MSQ) Score Change From Baseline to Week 6 (Observed).
Change from Baseline in MSQ Score at Week 6
Medication Satisfaction Questionnaire (MSQ) - Categorical Summary - Dichotomized Categories - Week 2 (Observed).
Week 2
Medication Satisfaction Questionnaire (MSQ) - Categorical Summary - Dichotomized Categories - Week 4 (Observed).
Week 4
- +7 more secondary outcomes
Other Outcomes (2)
Positive and Negative Syndrome Scale (PANSS) Total Score Change From Baseline to Week 6 Endpoint
Change from Baseline to Week 6 LOCF
Clinical Global Impression - Severity (CGI-S) Change From Baseline to Week 6 Endpoint
Change from Baseline to Week 6 LOCF
Study Arms (2)
002
EXPERIMENTALOral Risperidone 4 or 6 mg MG once daily for 0-2 weeks
001
EXPERIMENTALPaliperidone ER 6, 9 or 12 MG once daily for 4-6 weeks
Interventions
Eligibility Criteria
You may qualify if:
- Must be able to understand, in the opinion of the investigator, the informed consent form.
- be diagnosed with schizophrenia
- report dissatisfaction with current medication
- have an aspect of schizophrenia management which could potentially benefit from a change in antipsychotic medication
- receive risperidone 4 mg or 6 mg for at least 4 weeks before the start of the study.
You may not qualify if:
- Unable to swallow study drug whole with the aid of water
- cannot have received an investigational drug, used an investigational medical device, or participated in a clinical study that altered their medication within 6 months before the first administration of study drug, or have participated in more than 2 investigational drug studies within the past 12 months
- no other major mental health diagnosis except for tobacco dependance
- no use of cocaine or heroin within 3 months before the first administration
- no history of treatment with any antipsychotic in addition to treatment with risperidone, or treatment with paliperidone, within 30 days before the baseline visit.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (40)
Unknown Facility
Cerritos, California, United States
Unknown Facility
Garden Grove, California, United States
Unknown Facility
Huntington Beach, California, United States
Unknown Facility
Pico Rivera, California, United States
Unknown Facility
San Diego, California, United States
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Santa Ana, California, United States
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Torrance, California, United States
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Atlanta, Georgia, United States
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Chicago, Illinois, United States
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Flowood, Mississippi, United States
Unknown Facility
Clementon, New Jersey, United States
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Brooklyn, New York, United States
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Philadelphia, Pennsylvania, United States
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Austin, Texas, United States
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Irving, Texas, United States
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Miami, FL, Argentina
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Buenos Aires, Argentina
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Ciudad Autonoma de, Argentina
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Cordoba Crd, Argentina
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Mendoza, Argentina
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Mendoza Men, Argentina
Unknown Facility
Rosario, Argentina
Unknown Facility
Barranquilla, Colombia
Unknown Facility
Bogotá, Colombia
Unknown Facility
Bogotá S/N, Colombia
Unknown Facility
Bucaramanga S/N, Colombia
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Pilsen, Czechia
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Prague, Czechia
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Sternberk, Czechia
Unknown Facility
Bojnice, Slovakia
Unknown Facility
Bratislava, Slovakia
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Michalovce, Slovakia
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Rimavská Sobota, Slovakia
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Žilina, Slovakia
Unknown Facility
Dnipropetrovsk, Ukraine
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Donetsk, Ukraine
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Kiev, Ukraine
Unknown Facility
Lviv, Ukraine
Unknown Facility
Odesa, Ukraine
Unknown Facility
Village Stepanovka Kherson, Ukraine
Related Publications (1)
Canuso CM, Grinspan A, Kalali A, Damaraju CV, Merriman U, Alphs L, Awad AG. Medication satisfaction in schizophrenia: a blinded-initiation study of paliperidone extended release in patients suboptimally responsive to risperidone. Int Clin Psychopharmacol. 2010 May;25(3):155-64. doi: 10.1097/YIC.0b013e3283372977.
PMID: 20216424DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Vice President, Medical Affairs, CNS
- Organization
- Ortho McNeil Janssen Scientific Affairs, LLC
Study Officials
- STUDY DIRECTOR
Johnson & Johnson Pharmaceutical Research & Development, L.L. C. Clinical Trial
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- LTE60
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 24, 2007
First Posted
September 26, 2007
Study Start
October 1, 2007
Primary Completion
July 1, 2008
Study Completion
July 1, 2008
Last Updated
May 9, 2014
Results First Posted
October 20, 2009
Record last verified: 2014-04