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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

Page last updated: August 23, 2015

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