28-30 Month Study Comparing Paliperidone Palmitate With Oral Risperidone for Treating Adults Diagnosed With Schizophrenia Within the Past 5 Years
Information source: Ortho-McNeil Janssen Scientific Affairs, LLC
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Schizophrenia
Intervention: paliperidone palmitate (Drug); oral risperidone (Drug)
Phase: Phase 4
Status: Terminated
Sponsored by: Ortho-McNeil Janssen Scientific Affairs, LLC Official(s) and/or principal investigator(s): Ortho-McNeil Janssen Scientific Affairs, LLC Clinical Trial, Study Director, Affiliation: Ortho-McNeil Janssen Scientific Affairs, LLC
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.
Clinical Details
Official title: 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
Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention
Primary outcome: Time to Relapse During Relapse Prevention Phase
Detailed description:
This is a Prospective, Randomized, Active-controlled, Rater-blinded Study to to assess the
efficacy 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.
Recently diagnosed is defined as first diagnosis of any psychotic disorder within 5 years
prior to screening. High risk of relapse is defined as having documented occurrence of 3
periods of breakthrough symptoms that required a change in patient care per the
investigator's judgment (e. g., increase in dose, addition of a new drug, increase in the
level of psychiatric care, notable increases in the frequency or intensity of patient
contact required to maintain outpatient status, psychiatric hospitalization, etc.) within
the previous 24 months, including 1 such period within the previous 6 months. Safety
evaluations will include Adverse Event (AE) reporting, hematology and clinical chemistry
laboratory tests, vital signs, electrocardiogram (ECG), and evaluations of suicidality and
sexual functioning. Patients will receive either paliperidone palmitate 50, 75, 100, or 150
mg eq. monthly by injection for two years or oral risperidone 2, 4, 6, or 8 mg tabs once
daily for two years.
Eligibility
Minimum age: 18 Years.
Maximum age: 35 Years.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
Locations and Contacts
Curitiba, Brazil
Salvador, Brazil
Sao Paulo, Brazil
Kazanlak, Bulgaria
Pleven, Bulgaria
Radnevo N/A, Bulgaria
Quebec, Canada
Baoding, China
Beijing, China
Changsha, China
Guangzhou, China
Kunming, China
Shanghai, China
Wuhan, China
Xi'An, China
Bogota, Colombia
Kutná Hora 1, Czech Republic
Olomouc 9, Czech Republic
Praha 10, Czech Republic
Praha 8, Czech Republic
Praha 9, Czech Republic
Strakonice 1, Czech Republic
Ahmedabad, India
Aurangabad, India
Calicut, India
Hyderabad, India
Jaipur, India
Lucknow Gpo, India
Mangalore, India
Pune, India
Varanasi, India
Chonju, Korea, Republic of
Gwangju, Korea, Republic of
Gyeonggi-Do, Korea, Republic of
Seoul, Korea, Republic of
Johor Bahru, Malaysia
Kuala Lumpur, Malaysia
Moscow, Russian Federation
Nizny Novgorod, Russian Federation
Samara N/A, Russian Federation
St Petersburg N/A, Russian Federation
St Petersburg, Russian Federation
St-Petersburg, Russian Federation
Yaroslavl N/A, Russian Federation
Kharkov, Ukraine
Kherson, Ukraine
Kiev, Ukraine
Odessa, Ukraine
Simferopol, Ukraine
Calgary, Alberta, Canada
Little Rock, Arkansas, United States
Garden Grove, California, United States
San Diego, California, United States
Washington, District of Columbia, United States
Kissimmee, Florida, United States
Tampa, Florida, United States
Chicago, Illinois, United States
Hoffman Estates, Illinois, United States
Kingsport, Indiana, United States
Lake Charles, Louisiana, United States
Shreveport, Louisiana, United States
Pittsfield, Massachusetts, United States
Minneapolis, Minnesota, United States
Flowood, Mississippi, United States
Creve Coeur, Missouri, United States
Saint Louis, Missouri, United States
Omaha, Nebraska, United States
Brooklyn, New York, United States
Halifax, Nova Scotia, Canada
Middleburg Heights, Ohio, United States
Sudbury, Ontario, Canada
Montreal, Quebec, Canada
Arlington, Texas, United States
Austin, Texas, United States
Irving, Texas, United States
Portsmount, Virginia, United States
Additional Information
Starting date: June 2009
Last updated: September 3, 2012
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