Long Term Study of RBP 7000 in the Treatment of Subjects With Schizophrenia
Condition: Schizophrenia
MeSH terms: Schizophrenia
Study type: Interventional
Phase: Phase 3

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.
    

Detailed description: 
      Patients to be screened must be diagnosed with schizophrenia with a designated score based on
      the PANSS, as confirmed by a State, Assessability, Face, Ecological and Rule (SAFER)
      interview. "De novo" patients are patients who are already receiving 3- or 4-mg oral
      risperidone/day and will not have to complete the "run-in" or "conversion" phases (see below)
      and will be assigned to receive RBP-7000 after eligibility has been confirmed. Patients who
      completed the double-blind, placebo-controlled, efficacy study of RBP-7000 (RB-US-09-0010,
      NCT02109562), conducted in patients with acute schizophrenia (referred to as "roll-over"
      patients) will be screened.

      All patients will be assigned the 120 mg dose of RBP-7000, which is subject to a one-time
      down-titration to 90-mg RBP-7000 for tolerability, at the investigator's discretion. Patients
      receiving the 90-mg dose of RBP-7000 who exhibit a worsening in psychiatric symptoms,
      confirmed by a total PANSS score >70 or a 20% increase in the PANSS score from the previous
      assessment at the 120-mg dose level (before the dose was decreased to 90 mg), can receive a
      one-time, up-titration back to 120-mg RBP-7000 at the discretion of the investigator.

      "De novo" patients entering into the study are those patients who did not participate in
      study RB-US-09-0010 (NCT02109562) and are allocated into three groups with different
      pre-study procedures to prepare for the treatment period:

        -  "Run-in" patients are patients who are not already receiving oral risperidone (as no
           other antipsychotic medications are allowed during study participation) and will begin a
           14-day run-in period by titrating up to a dose of 3 or 4 mg oral risperidone/day before
           the first injection of RBP-7000.

        -  "Conversion" patients are patients who are receiving oral risperidone doses other than 3
           or 4mg/day and will begin a 7-day conversion period to achieve an oral risperidone dose
           level of 3 or 4-mg before the first injection of RBP-7000, only if clinically indicated.

        -  De novo patients taking an oral risperidone dose of 3 or 4 mg/day prestudy will (once
           screened/enrolled) receive the first injection of RBP-7000.

      "Roll-over" patients entering into the study are patients who completed 56 days of
      double-blind treatment in Study RB-US-09-0010. These patients will be eligible to enter the
      current study provided that continuation of treatment is clinically warranted, as judged by
      the investigator, and that there have been no significant protocol deviations or clinically
      relevant adverse events (AEs) that would preclude inclusion in this study. Roll-over patients
      will not undergo the complete screening process and will not require either a run-in or
      conversion period with oral risperidone. On Day 1 of the open-label study (which is Day 57 of
      Study RB-US-09-0010), patients will receive their first injection (120 mg) of open label
      RBP-7000.
    

Intervention name(s): RBP-7000
Intervention type(s): Drug
Intervention description(s): 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.
Other intervention name(s): Risperidone; Long-acting Risperidone
Intervention MeSH terms: Risperidone
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Schizophrenia; Schizophrenic; Schizophrenias; Risperidone; Long-acting Risperidone; Atrigel; Subcutaneous