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

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.

Study Overview

• Status: Terminated
• Conditions: Schizophrenia
• Intervention / Treatment: Drug: paliperidone palmitate; Drug: oral risperidone

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.

• Study Type: Interventional
• Enrollment (Actual): 163
• Phase: Phase 4

Contacts and Locations

Study Locations

• Brazil
  • Curitiba, Brazil
  • Salvador, Brazil
  • Sao Paulo, Brazil
• Bulgaria
  • Kazanlak, Bulgaria
  • Pleven, Bulgaria
  • Radnevo N/A, Bulgaria
• Canada
  • Quebec, Canada
  • Alberta
    • Calgary, Alberta, Canada
  • Nova Scotia
    • Halifax, Nova Scotia, Canada
  • Ontario
    • Sudbury, Ontario, Canada
  • Quebec
    • Montreal, Quebec, Canada
• China
  • Baoding, China
  • Beijing, China
  • Changsha, China
  • Guangzhou, China
  • Kunming, China
  • Shanghai, China
  • Wuhan, China
  • Xi'An, China
• Colombia
  • Bogota, Colombia
• Czech Republic
  • 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
• India
  • Ahmedabad, India
  • Aurangabad, India
  • Calicut, India
  • Hyderabad, India
  • Jaipur, India
  • Lucknow Gpo, India
  • Mangalore, India
  • Pune, India
  • Varanasi, India
• Korea, Republic of
  • Chonju, Korea, Republic of
  • Gwangju, Korea, Republic of
  • Gyeonggi-Do, Korea, Republic of
  • Seoul, Korea, Republic of
• Malaysia
  • Johor Bahru, Malaysia
  • Kuala Lumpur, Malaysia
• Russian Federation
  • Moscow, Russian Federation
  • Nizny Novgorod, Russian Federation
  • Samara N/A, Russian Federation
  • St Petersburg, Russian Federation
  • St Petersburg N/A, Russian Federation
  • St-Petersburg, Russian Federation
  • Yaroslavl N/A, Russian Federation
• Ukraine
  • Kharkov, Ukraine
  • Kherson, Ukraine
  • Kiev, Ukraine
  • Odessa, Ukraine
  • Simferopol, Ukraine
• United States
  • Arkansas
    • Little Rock, Arkansas, United States
  • California
    • Garden Grove, California, United States
    • San Diego, California, United States
  • District of Columbia
    • Washington, District of Columbia, United States
  • Florida
    • Kissimmee, Florida, United States
    • Tampa, Florida, United States
  • Illinois
    • Chicago, Illinois, United States
    • Hoffman Estates, Illinois, United States
  • Indiana
    • Kingsport, Indiana, United States
  • Louisiana
    • Lake Charles, Louisiana, United States
    • Shreveport, Louisiana, United States
  • Massachusetts
    • Pittsfield, Massachusetts, United States
  • Minnesota
    • Minneapolis, Minnesota, United States
  • Mississippi
    • Flowood, Mississippi, United States
  • Missouri
    • Creve Coeur, Missouri, United States
    • Saint Louis, Missouri, United States
  • Nebraska
    • Omaha, Nebraska, United States
  • New York
    • Brooklyn, New York, United States
  • Ohio
    • Middleburg Heights, Ohio, United States
  • Texas
    • Arlington, Texas, United States
    • Austin, Texas, United States
    • Irving, Texas, United States
  • Virginia
    • Portsmount, Virginia, United States

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 35 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 001; paliperidone palmitate 50 75 100 or 150 mg eq. monthly injection for 2 years	Drug: paliperidone palmitate; 50, 75, 100, or 150 mg eq. monthly injection for 2 years
Active Comparator: 002; oral risperidone 2 4 6 or 8 mg tabs once daily for two years	Drug: oral risperidone; 2, 4, 6, or 8 mg tabs once daily for two years

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Ortho-McNeil Janssen Scientific Affairs, LLC

Study record dates

Study Major Dates

• Study Start: June 1, 2009
• Primary Completion (Actual): March 1, 2010
• Study Completion (Actual): March 1, 2010

Study Registration Dates

• First Submitted: July 2, 2009
• First Submitted That Met QC Criteria: July 24, 2009
• First Posted (Estimate): July 27, 2009

Study Record Updates

• Last Update Posted (Estimate): September 10, 2012
• Last Update Submitted That Met QC Criteria: September 3, 2012
• Last Verified: September 1, 2012

More Information

Terms related to this study

• Keywords: Schizophrenia; Risperidone; Paliperidone Palmitate; Risperdal; Invega Sustenna
• Additional Relevant MeSH Terms: Mental Disorders; Schizophrenia Spectrum and Other Psychotic Disorders; Schizophrenia; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Central Nervous System Depressants; Antipsychotic Agents; Tranquilizing Agents; Psychotropic Drugs; Serotonin Agents; Dopamine Agents; Serotonin 5-HT2 Receptor Antagonists; Serotonin Antagonists; Dopamine D2 Receptor Antagonists; Dopamine Antagonists; Paliperidone Palmitate; Risperidone
• Other Study ID Numbers: CR015646; R092670SCH3004 (Other Identifier: Ortho-McNeil Janssen Scientific Affairs, LLC)