Long Term Study of RBP 7000 in the Treatment of Subjects With Schizophrenia
Condition: Schizophrenia
MeSH terms: Schizophrenia
Intervention: RBP-7000
Intervention description: 120-mg RBP-7000 dose delivered by subcutaneous injection every 28 days for a total of 13 injections (for roll-over participants, the first two injections took place under study RB-US-09-0010).
A one-time down-titration to 90 mg RBP-7000 is permitted at the investigator's discretion should the participant have tolerability issues. Participants who received the 90-mg dose of RBP-7000 and exhibited a worsening in psychiatric symptoms could receive a one-time up-titration back to 120 mg RBP-7000 at the discretion of the investigator.
RBP-7000 is a combination of the ATRIGEL Delivery System and risperidone. The ATRIGEL Delivery System allows for sustained-release of risperidone in a controlled manner.
Intervention MeSH terms: Risperidone
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 500.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No
Keywords: Schizophrenia; Schizophrenic; Schizophrenias; Risperidone; Long-acting Risperidone; Atrigel; Subcutaneous

Summary:

      This is a Phase 3, open label study administering RBP-7000 in the treatment of patients with
      schizophrenia. Study will assess the long-term safety and tolerability of RBP-7000
      subcutaneous (SC) injections in subjects with schizophrenia and to continue collecting
      clinical outcome data with RBP-7000 SC injections in subjects with schizophrenia using the
      Positive and Negative Syndrome Scale (PANSS) and Clinical Global Impression-Severity Illness
      (CGI-S) scale.
    

Eligibility criteria:

        Inclusion Criteria:

        "De Novo" Patients

          -  Diagnosis of schizophrenia as defined by Diagnostic and Statistical Manual, Edition 4,
             text revision (DSM-IV-TR) criteria

          -  Total PANSS score <=70 at the time of screening (Visit 1)

          -  Otherwise healthy on the basis of physical examinatIon

          -  Provided written informed consent

        "Roll-over Patients

          -  Provided written consent to participate in this study

          -  Be considered eligible to enroll based on End of Study (EOS) (Day 57 of Study
             RB-US-09-0010) assessments and the medical judgment of the investigator

        Exclusion Criteria:

        "De Novo" Patients

          -  Patients taking daily oral risperidone at a dose plus/minus 6 mg/day

          -  Patients taking any risperidone or 9-hydroxyrisperidone long-acting injectable
             formulation within 120 days of study screening (Visit 1)

          -  Patients who have received a long-acting injectable antipsychotic within 120 days of
             screening (Visit 1)

          -  Patients with evidence or history (in the past six months prior to screening) of a
             significant hepatic disorder that may either compromise patient safety or interfere
             with the safety and/or outcome evaluation of the study drug, including:

               -  Acute or chronic hepatitis, including but not limited to hepatitis B or C

               -  Total bilirubin greater than 1.5 times the upper limit of normal (ULN), or

               -  Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) greater than 2
                  times ULN

          -  Patients with a history of drug-induced leukopenia

          -  Patients with other medical conditions including, but not limited to, history of heart
             attack (myocardial infarction) or brain injury (traumatic injury with loss of
             consciousness and/or cerebrovascular accident), and clinically significant low blood
             pressure or arrhythmias as interpreted by the primary investigator (PI) or medically
             qualified sub-investigator

          -  Patients with epilepsy or other seizure disorders, Parkinson's disease or dementia

        "Roll-over" Patients

          -  Patients requiring an inpatient treatment setting at the end of Study RB-US-09-0010

          -  Patients with an unstable medical condition developed during Study RB-US-09-0010

          -  Women of childbearing potential who have a positive pregnancy test at screening (Visit
             1), who are pregnant or breastfeeding, seeking pregnancy, or failing to use adequate
             contraceptive methods during the study