Comparison of Paliperidone Palmitate and RISPERDAL CONSTA in Patients With Schizophrenia
A Randomized, Double-Blind, Parallel-Group, Comparative Study of Flexible Doses of Paliperidone Palmitate and Flexible Doses of Risperidone Long-Acting Intramuscular Injection in Subjects With Schizophrenia
2 other identifiers
interventional
1,221
13 countries
79
Brief Summary
The purpose of this study is to demonstrate the effectiveness of paliperidone palmitate in patients with Schizophrenia.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3 schizophrenia
Started Mar 2007
79 active sites
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 Start
First participant enrolled
March 1, 2007
CompletedFirst Submitted
Initial submission to the registry
December 21, 2007
CompletedFirst Posted
Study publicly available on registry
January 10, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2009
CompletedResults Posted
Study results publicly available
October 4, 2011
CompletedJune 24, 2014
June 1, 2014
2.3 years
December 21, 2007
August 30, 2011
June 11, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change in the Positive and Negative Syndrome Scale (PANSS) Total Score for Schizophrenia
The PANSS scale is used to assess the neuropsychiatric symptoms of schizophrenia. The 30-item PANSS scale provides a total score (sum of the scores of all 30 items) and scores for 3 subscales, the positive subscale (7 items), the negative subscale (7 items),and the general psychopathology subscale (16 items), each item rated on a scale of 1 (absent) to 7 (extreme).
Baseline to the last postrandomization assessment in the double-blind treatment period (approximately 13 weeks)
Secondary Outcomes (2)
The Change From Baseline for the CGI-S Score
Baseline to the last postrandomization assessment in the double-blind treatment period (approximately 13 weeks)]
The Change From Baseline in the PSP Score
Baseline to the last postrandomization assessment in the double-blind treatment period (approximately 13 weeks)
Study Arms (2)
RISPERDAL CONSTA
ACTIVE COMPARATORRISPERDAL CONSTA 25-50 mg eq every 2 weeks
R092670
EXPERIMENTALPaliperidone Palmitate 50-150 mg eq every 4 wks
Interventions
RISPERDAL CONSTA: Type=exact number, unit=mg, number=25, 37.5, or 50, form=suspension for injection, route=Intramuscular use. One i.m. injection of RISPERDAL CONSTA 25-50 mg eq every 2 weeks at V4, V6, V7, V8, V9, and V10. PALIPERIDONE PALMITATE PLACEBO: Form=suspension for injection, route=Intramuscular use. One i.m. injection every 2 weeks at Baseline and at V4, V7, and V9. RISPERIDONE: Type=up to, unit=mg, number=1 to 6, form=Tablet, route=Oral Use. One tablet for the first 4 weeks (28 days) of the DB treatment period.
PALIPERIDONE PALMITATE: Type=exact number, unit=mg, number=50, 100, or 150, form=suspension for injection, route=Intramuscular use. One i.m. injection of Paliperidone palmitate 50-150 mg eq every 4 wks at Baseline, V4, V7, and V9. RISPERDAL CONSTA PLACEBO: Form=suspension for injection, route=Intramuscular use. One i.m. injection every 4 weeks at Baseline, V4, V7, and V9.
Eligibility Criteria
You may qualify if:
- Meet diagnostic criteria for schizophrenia according to Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (DSM-IV) criteria as specified by the protocol for at least 1 year before screening
- Prior medical records, written documentation or verbal information obtained from previous psychiatric providers obtained by the investigator must be consistent with the diagnosis of schizophrenia
- A total PANSS score between 60 and 120, inclusive, at screening and baseline; Body mass index (BMI) at the screening visit BMI at least 17 kg/m2
- Female patients must be postmenopausal for at least 2 years, surgically sterile, abstinent, or, if sexually active, be practicing an effective method of birth control before study entry and throughout the study as specified by the protocol. Women of childbearing potential must have a negative serum beta-human chorionic gonadotropin (b hCG) pregnancy test result at screening.
You may not qualify if:
- Patient unable to provide consent or involuntarily committed to psychiatric hospitalization; A primary, active DSM-IV diagnosis on Axis I other than schizophrenia
- History of treatment resistance as defined by failure to respond to 2 adequate treatments with different antipsychotic medications (an adequate treatment is defined as a minimum of 6 weeks at maximum tolerated dosage)
- Relevant history or current presence of any significant or unstable cardiovascular, respiratory, neurologic (including seizures or significant cerebrovascular disease), renal, hepatic, hematologic, endocrine, immunologic, or other systemic disease including history of neuroleptic malignant syndrome; History of any severe pre-existing gastrointestinal narrowing or inability to swallow oral study drug whole with the aid of water (applies to those patients requiring oral tolerability only)
- Significant risk of suicidal or violent behavior, as clinically assessed by the investigator ; History of life-threatening allergic reaction to any drug; Known or suspected hypersensitivity or intolerance to risperidone, paliperidone, 20% Intralipid, or any of their excipients (e.g., soybean oil, egg yolks, phospholipids, and glycerol)
- Have received an experimental drug or experimental biologic, or used an experimental medical device within 6 months before screening; History of any active malignancy within the previous 5 years, with the exception of basal cell carcinomas
- Women who are pregnant or breast-feeding or are planning to become pregnant uring the study
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (82)
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Birmingham, Alabama, United States
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Little Rock, Arkansas, United States
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Cerritos, California, United States
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Garden Grove, California, United States
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Los Angeles, California, United States
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Washington D.C., District of Columbia, 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
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Hollis, New York, United States
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Willoughby, Ohio, United States
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Oklahoma City, Oklahoma, United States
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DeSoto, Texas, United States
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Houston, Texas, United States
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Odessa, Texas, United States
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Linz, Austria
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Salzburg, Austria
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Vienna, Austria
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Plovdiv, Bulgaria
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Varna, Bulgaria
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Brno, Czechia
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Dobřany, Czechia
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Kroměříž, Czechia
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Kutná Hora, Czechia
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Olomouc, Czechia
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Prague, Czechia
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Pärnu, Estonia
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Tallinn, Estonia
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Tartu, Estonia
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Bourges Cedex N/A, France
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Dole, France
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Romans-sur-Isère, France
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Achim, Germany
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Berlin, Germany
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Bielefeld, Germany
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Bochum, Germany
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Jena, Germany
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Leipzig, Germany
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Mannheim, Germany
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München, Germany
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Stralsund, Germany
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Baja, Hungary
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Budapest, Hungary
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Gyõr, Hungary
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Kalocsa, Hungary
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Nagykálló, Hungary
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Aurangabad, India
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Bangalore, India
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Chandigarh, India
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Mangalore, India
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Pune, India
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Varanasi, India
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Alytus, Lithuania
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Kaunas, Lithuania
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Klaipėda, Lithuania
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Vilnius, Lithuania
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Bełchatów, Poland
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Bytom Na, Poland
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Chełmno, Poland
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Gdynia Na, Poland
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Katowice Woj Slaskie, Poland
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Krakow Na, Poland
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Lubliniec, Poland
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Piekary Slaskie Na, Poland
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Skorzewo Na, Poland
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Warszawa Na, Poland
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Moscow, Russia
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Moscow Russia, Russia
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Nizny Novgorod, Russia
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Saint Petersburg, Russia
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Saratov, Russia
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Yaroslavl, Russia
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Barcelona, Spain
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Madrid, Spain
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San Juan, Spain
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Dnipro, Ukraine
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Donetsk, Ukraine
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Kharkiv, Ukraine
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Kiev, Ukraine
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Kyiv, Ukraine
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Odesa, Ukraine
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Simferopol, Ukraine
Related Publications (4)
Alphs L, Bossie CA, Fu DJ, Ma YW, Kern Sliwa J. Onset and persistence of efficacy by symptom domain with long-acting injectable paliperidone palmitate in patients with schizophrenia. Expert Opin Pharmacother. 2014 May;15(7):1029-42. doi: 10.1517/14656566.2014.909409.
PMID: 24754314DERIVEDFu DJ, Bossie CA, Sliwa JK, Ma YW, Alphs L. Paliperidone palmitate versus oral risperidone and risperidone long-acting injection in patients with recently diagnosed schizophrenia: a tolerability and efficacy comparison. Int Clin Psychopharmacol. 2014 Jan;29(1):45-55. doi: 10.1097/YIC.0000000000000006.
PMID: 24113628DERIVEDFu DJ, Bossie CA, Kern Sliwa J, Ma YW, Alphs L. Paliperidone palmitate versus risperidone long-acting injection in markedly-to-severely ill schizophrenia subjects: onset of efficacy with recommended initiation regimens. Clin Schizophr Relat Psychoses. 2014 Jul;8(2):101-9, 109A.
PMID: 23446197DERIVEDPandina G, Lane R, Gopal S, Gassmann-Mayer C, Hough D, Remmerie B, Simpson G. A double-blind study of paliperidone palmitate and risperidone long-acting injectable in adults with schizophrenia. Prog Neuropsychopharmacol Biol Psychiatry. 2011 Jan 15;35(1):218-26. doi: 10.1016/j.pnpbp.2010.11.008. Epub 2010 Nov 16.
PMID: 21092748DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Limitations and Caveats
Of 1221 patients randomized, one patient was enrolled twice and assigned 2 patient numbers. Only the first patient number is included in the results reported for 1220 randomized patients.
Results Point of Contact
- Title
- Clinical Leader Psychiatry
- Organization
- Johnson & Johnson Pharmaceutical Research & Development 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
- GT60
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- 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
December 21, 2007
First Posted
January 10, 2008
Study Start
March 1, 2007
Primary Completion
June 1, 2009
Study Completion
June 1, 2009
Last Updated
June 24, 2014
Results First Posted
October 4, 2011
Record last verified: 2014-06