Risperidone LA Heathcare Resource Study
Condition: Psychosis; Schizophrenia
MeSH terms: Schizophrenia; Psychotic Disorders; Mental Disorders
Study type: Interventional
Phase: Phase 4

Summary: 
      The primary objective of this pilot study is to evaluate the impact of switching 30 subjects
      from an existing antipsychotic to risperidone long acting on healthcare resource utilization.
      The study will be a ten month open-label, 'mirror-image', pilot study. Healthcare resource
      utilization during the 10 months prior to starting risperidone long acting will be
      retrospectively collected for all subjects (period A) at the beginning of the study. The
      utilization of direct medical resources will also be collected for 10 months after initiation
      of risperidone long acting (period B). In this design the patients will serve as their own
      control.
    

Detailed description: 
      Screening (Week -2 to Week 0; Days -14 to -1) In this phase, the subject is required to be
      treated with oral risperidone (as their only antipsychotic) for a period of at least 5 days
      before entering the stabilization phase of the study. Therefore,

        -  If the subject is currently treated with an antipsychotic other than risperidone, the
           dosage will be tapered gradually and discontinued. Simultaneously, oral risperidone will
           be started at 2 mg/day and increased to no more than 6 mg/day. The subject will be
           treated with risperidone monotherapy for at least five days prior to entering the
           stabilization phase of the study.

        -  On the other hand, if the patient has already been treated for more than 5 days with
           risperidone monotherapy then he/she may enter the stabilization phase of the study
           immediately.

      Stabilization Phase (Weeks 1 - 14; Days 0 - 98) The first three doses of risperidone long
      acting (Days 0, 14 and 28) will be 25 mg for all subjects. At the time of the fourth
      injection (Day 42), the dosage of risperidone long acting may be increased from 25 mg IM to
      37.5 mg IM upon discretion of the treating physician. Further increases in the dosage of
      risperidone long acting may be made at the time of the 6th and 8th injections (Days 70 and 98
      respectively). In this case, if the subject is currently receiving 25 mg he/she may be
      increased to 37.5 mg but not 50 mg. Alternatively, if the patient is currently receiving 37.5
      mg, then subject may be increased to the maximum recommended dosage of 50 mg IM every two
      weeks.

      To accommodate for the latency period (i.e., the time for risperidone to be released from the
      microspheres and approach therapeutic plasma levels), subjects entering into the study will
      continue on oral risperidone for the first three weeks (Days 0-21). Temporary oral
      supplementation will also be permitted anytime during the stabilization phase of the study
      when considered by the treating physician to be clinically necessary for the treatment of
      breakthrough psychosis. With only one exception, the treating physician is not restricted
      from adding or discontinuing any pharmacological treatment deemed necessary for the clinical
      management of the subject. The exception in this case prohibits the addition of another
      antipsychotic agent and applies only to the stabilization phase of the study.

      Maintenance Phase (Weeks 15 - 38; Days 99 - 266) Patients that have shown adequate response
      to risperidone long acting will continue into the maintenance phase of the study. From this
      point onwards, the treating physician may change the dosage of risperidone long acting at any
      time as considered necessary. Temporary oral supplementation will also be permitted during
      the maintenance phase when considered by the treating physician to be clinically necessary
      for the treatment of breakthrough psychosis. Apart from the above, the treating physician is
      not restricted from adding or discontinuing any pharmacological treatment (including another
      antipsychotic) deemed necessary for the clinical management of the subject.
    

Intervention name(s): Risperidone
Intervention type(s): Drug
Intervention description(s): See Detailed Description.
Intervention MeSH terms: Risperidone
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Psychosis; schizophrenia; schizoaffective; risperidone