Study Stopped
The recruitment rate for the study was inadequate to achieve its enrollment goals.
28-30 Month Study Comparing Paliperidone Palmitate With Oral Risperidone for Treating Adults Diagnosed With Schizophrenia Within the Past 5 Years
A Prospective, Randomized, Active-controlled, Rater-blinded Study of the Prevention of Relapse Comparing Paliperidone Palmitate With Oral Risperidone in Adults With Recently-Diagnosed Schizophrenia Who Are at High Risk of Relapse
2 other identifiers
interventional
163
12 countries
72
Brief Summary
The study will assess the use of paliperidone palmitate compared with oral risperidone in delaying time to relapse in patients recently diagnosed with schizophrenia who are at high risk of relapse.
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 Jun 2009
Shorter than P25 for phase_4 schizophrenia
72 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
Study Start
First participant enrolled
June 1, 2009
CompletedFirst Submitted
Initial submission to the registry
July 2, 2009
CompletedFirst Posted
Study publicly available on registry
July 27, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2010
CompletedResults Posted
Study results publicly available
July 16, 2012
CompletedSeptember 10, 2012
September 1, 2012
9 months
July 2, 2009
March 8, 2011
September 3, 2012
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Time to Relapse During Relapse Prevention Phase
Time to relapse during the relapse prevention phase was the primary efficacy variable of the study. Each case of potential relapse event were to be reviewed in a blinded fasion by an independent Relapse Monitoring Board, comprised of experts in the diagnostic, clinical and therapeutic management of schizophrenia.
24 months
Study Arms (2)
001
EXPERIMENTALpaliperidone palmitate 50 75 100 or 150 mg eq. monthly injection for 2 years
002
ACTIVE COMPARATORoral risperidone 2 4 6 or 8 mg tabs once daily for two years
Interventions
Eligibility Criteria
You may qualify if:
- Patients must be, in the opinion of the investigator, able to understand the informed consent form approved by the Institutional Review Board (IRB) or Independent Ethics Committee (IEC), as appropriate
- All patients must sign the study informed consent document indicating that they understand the purpose of and procedures required for the study and are willing to participate in the study
- Must have a current diagnosis of schizophrenia
- must have had 3 periods of breakthrough symptoms that required a change in patient care as determined by the investigator (e.g. increase in dose, addition of a new drug, hospitalization, increase in the level of psychiatric care, notable increases in the frequency or intensity of patient contact required to maintain outpatient status, etc.) within the previous 24 months, including 1 such period within the previous 6 months
- Women must be postmenopausal, surgically sterile, or otherwise be incapable of pregnancy, abstinent, or if sexually active, be practicing a highly effective method of birth control before entry, and must agree to continue to use the same method of contraception throughout the study
- Women of childbearing potential must have a negative urine pregnancy test at screening
- Patients must be cooperative and reliable, agree to receive regular injections, and be willing/able to adhere to the prohibitions and restrictions specified in this protocol.
You may not qualify if:
- Patients who are unable to provide their own consent or are involuntarily committed to psychiatric hospitalization
- Have attempted suicide within 12 months before screening or are at imminent risk of suicide or violent behavior
- Have a positive urine drug screen test for barbiturates, cocaine, amphetamines, or opiates at screening
- Patients who are in their first episode of psychosis
- Patients currently meeting criteria for any other Axis I diagnosis except substance abuse or an Axis II diagnosis of Mental Retardation or Borderline Personality Disorder
- Meet the Diagnostic and Statistical Manual of Mental Health Disorders fourth edition (DSM-IV) definition of substance dependence (except for nicotine and caffeine dependence) within 6-months prior to entry
- Patients with known allergies, hypersensitivity (anaphylaxis-type reaction), or intolerance to paliperidone palmitate, risperidone, Risperdal®, Risperdal® Consta®, or INVEGA® or its excipients
- Patients who received Long Acting Therapy (LAT) treatment within 2 injection cycles prior to screening
- Women who are pregnant or breast-feeding, or planning to become pregnant.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (72)
Unknown Facility
Little Rock, Arkansas, United States
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Garden Grove, California, United States
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San Diego, California, United States
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Washington D.C., District of Columbia, United States
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Kissimmee, Florida, United States
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Tampa, Florida, United States
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Chicago, Illinois, United States
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Hoffman Estates, Illinois, United States
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Kingsport, Indiana, United States
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Lake Charles, Louisiana, United States
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Shreveport, Louisiana, United States
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Pittsfield, Massachusetts, United States
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Minneapolis, Minnesota, United States
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Flowood, Mississippi, United States
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Creve Coeur, Missouri, United States
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St Louis, Missouri, United States
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Omaha, Nebraska, United States
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Brooklyn, New York, United States
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Middleburg Heights, Ohio, United States
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Arlington, Texas, United States
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Austin, Texas, United States
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Irving, Texas, United States
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Portsmount, Virginia, United States
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Curitiba, Brazil
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Salvador, Brazil
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São Paulo, Brazil
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Kazanlak, Bulgaria
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Pleven, Bulgaria
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Radnevo, Bulgaria
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Calgary, Alberta, Canada
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Halifax, Nova Scotia, Canada
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Greater Sudbury, Ontario, Canada
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Montreal, Quebec, Canada
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Québec, Quebec, Canada
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Baoding, China
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Beijing, China
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Changsha, China
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Guangzhou, China
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Kunming, China
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Shanghai, China
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Wuhan, China
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Xi'an, China
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Bogotá, Colombia
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Kutná Hora, Czechia
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Olomouc, Czechia
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Prague, Czechia
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Strakonice, Czechia
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Ahmedabad, India
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Aurangabad, India
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Calicut, India
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Hyderabad, India
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Jaipur, India
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Lucknow Gpo, India
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Mangalore, India
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Pune, India
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Varanasi, India
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Johor Bahru, Malaysia
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Kuala Lumpur, Malaysia
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Moscow, Russia
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Nizny Novgorod, Russia
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Saint Petersburg, Russia
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Samara, Russia
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Yaroslavl, Russia
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Gwangju, South Korea
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Gyeonggi-do, South Korea
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Jeonju, South Korea
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Seoul, South Korea
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Kharkiv, Ukraine
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Kherson, Ukraine
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Kiev, Ukraine
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Odesa, Ukraine
Unknown Facility
Simferopol, Ukraine
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Limitations and Caveats
No efficacy analysis was performed due to early termination of the study (only 2 patients were randomized at the time of study termination).
Results Point of Contact
- Title
- Clinical Project Scientist
- Organization
- Ortho-McNeil Janssen Scientific Affairs, LLC
Study Officials
- STUDY DIRECTOR
Ortho-McNeil Janssen Scientific Affairs, LLC Clinical Trial
Ortho-McNeil Janssen Scientific Affairs, LLC
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 2, 2009
First Posted
July 27, 2009
Study Start
June 1, 2009
Primary Completion
March 1, 2010
Study Completion
March 1, 2010
Last Updated
September 10, 2012
Results First Posted
July 16, 2012
Record last verified: 2012-09