28-30 Month Study Comparing Paliperidone Palmitate With Oral Risperidone for Treating Adults Diagnosed With Schizophrenia Within the Past 5 Years
Condition: Schizophrenia
MeSH terms: Schizophrenia
Intervention: paliperidone palmitate; oral risperidone
Intervention description: 50, 75, 100, or 150 mg eq. monthly injection for 2 years; 2, 4, 6, or 8 mg tabs once daily for two years
Intervention MeSH terms: Risperidone; Paliperidone Palmitate
Phase: Phase 4
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 163.0
Sex: All
Minimum age: 18 Years
Maximum age: 35 Years
Healthy volunteers: No
Keywords: Schizophrenia; Risperidone; Risperdal; Paliperidone Palmitate; Invega Sustenna

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.
    

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.