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”

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 Type: Interventional

Study Design: Prevention, Randomized, Open Label, Parallel Assignment, Safety/Efficacy Study

Study Primary Completion Date: January 2013

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 AE reporting, labs, vital signs, 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.

Intervention(s) in this Clinical Trial

• Drug: oral risperidone
  • 2, 4, 6, or 8 mg tabs once daily for two years
• Drug: paliperidone palmitate
  • 50, 75, 100, or 150 mg eq. monthly injection for 2 years

Arms, Groups and Cohorts in this Clinical Trial

• Experimental: 001
  • 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

Primary Measures

• Time to relapse as determined by blinded relapse monitoring board
  • Time Frame: Monthly
    Safety Issue?: No

Secondary Measures

• Evaluation of the impact of paliperidone palmitate compared with oral risperidone with respect to personal and social functioning
  • Time Frame: Month
    Safety Issue?: No
• Assessment of the safety and tolerability of paliperidone palmitate in this study population through monitoring adverse events, laboratory tests, vital signs including weight, physical examinations, movement disorders, sexual functioning and suicidality
  • Time Frame: Monthly
    Safety Issue?: Yes

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 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

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: 35 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: Ortho-McNeil Janssen Scientific Affairs, LLC

Overall Clinical Trial Officials and Contacts

Ortho-McNeil Janssen Scientific Affairs, LLC Clinical Trial Study Director Ortho-McNeil Janssen Scientific Affairs, LLC  

Overall Contact: Use link at the bottom of the page to see if you qualify for an enrolling site (see list). If you still have questions:  info1@veritasmedicine.com

Information obtained from ClinicalTrials.gov on March 10, 2010

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00946985

Study ID Number: CR015646

ClinicalTrials.gov Identifier: NCT00946985

Health Authority: United States: Food and Drug Administration

To learn how to participate in this trial please click here.