28-30 Month Study Comparing Paliperidone Palmitate With Oral Risperidone for Treating Adults Diagnosed With Schizophrenia Within the Past 5 Years

NCT ID: NCT00946985

Last Updated: 2012-09-10

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE4
• Total Enrollment: 163 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-06-30
• Study Completion Date: 2010-03-31

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.

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.

Conditions

Schizophrenia

Keywords

Schizophrenia; Risperidone; Risperdal; Paliperidone Palmitate; Invega Sustenna

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

001

paliperidone palmitate 50 75 100 or 150 mg eq. monthly injection for 2 years

Group Type: EXPERIMENTAL

paliperidone palmitate

Intervention Type: DRUG

50, 75, 100, or 150 mg eq. monthly injection for 2 years

002

oral risperidone 2 4 6 or 8 mg tabs once daily for two years

Group Type: ACTIVE_COMPARATOR

oral risperidone

Intervention Type: DRUG

2, 4, 6, or 8 mg tabs once daily for two years

Interventions

paliperidone palmitate

50, 75, 100, or 150 mg eq. monthly injection for 2 years

Intervention Type: DRUG

oral risperidone

2, 4, 6, or 8 mg tabs once daily for two years

Intervention Type: DRUG

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 35 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Ortho-McNeil Janssen Scientific Affairs, LLC

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Ortho-McNeil Janssen Scientific Affairs, LLC Clinical Trial

Role: STUDY_DIRECTOR

Ortho-McNeil Janssen Scientific Affairs, LLC

Locations

Little Rock, Arkansas, United States

Garden Grove, California, United States

San Diego, California, United States

Washington D.C., 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

St Louis, Missouri, United States

Omaha, Nebraska, United States

Brooklyn, New York, United States

Middleburg Heights, Ohio, United States

Arlington, Texas, United States

Austin, Texas, United States

Irving, Texas, United States

Portsmount, Virginia, United States

Curitiba, , Brazil

Salvador, , Brazil

São Paulo, , Brazil

Kazanlak, , Bulgaria

Pleven, , Bulgaria

Radnevo, , Bulgaria

Calgary, Alberta, Canada

Halifax, Nova Scotia, Canada

Greater Sudbury, Ontario, Canada

Montreal, Quebec, Canada

Québec, Quebec, Canada

Baoding, , China

Beijing, , China

Changsha, , China

Guangzhou, , China

Kunming, , China

Shanghai, , China

Wuhan, , China

Xi'an, , China

Bogotá, , Colombia

Kutná Hora, , Czechia

Olomouc, , Czechia

Prague, , Czechia

Strakonice, , Czechia

Ahmedabad, , India

Aurangabad, , India

Calicut, , India

Hyderabad, , India

Jaipur, , India

Lucknow Gpo, , India

Mangalore, , India

Pune, , India

Varanasi, , India

Johor Bahru, , Malaysia

Kuala Lumpur, , Malaysia

Moscow, , Russia

Nizny Novgorod, , Russia

Saint Petersburg, , Russia

Samara, , Russia

Yaroslavl, , Russia

Gwangju, , South Korea

Gyeonggi-do, , South Korea

Jeonju, , South Korea

Seoul, , South Korea

Kharkiv, , Ukraine

Kherson, , Ukraine

Kiev, , Ukraine

Odesa, , Ukraine

Simferopol, , Ukraine

Countries

Argentina; Mexico; Philippines; Romania; Singapore; United States; Brazil; Bulgaria; Canada; China; Colombia; Czechia; India; Malaysia; Russia; South Korea; Ukraine

Other Identifiers

R092670SCH3004

Identifier Type: OTHER

Identifier Source: secondary_id

CR015646

Identifier Type: -

Identifier Source: org_study_id