Study to Evaluate the Efficacy and Safety of Risperidone in Situ Microparticle (ISM)® in Patients With Acute Schizophrenia
Condition: Acute Schizophrenia
MeSH terms: Schizophrenia
Study type: Interventional
Phase: Phase 3

Summary: 
      This is a multicenter, randomized, double-blind, placebo-controlled study designed to
      evaluate the efficacy and safety of intramuscular (IM) injections of Risperidone ISM® (75 or
      100 mg) or placebo, in patients with acute exacerbation of schizophrenia.
    

Detailed description: 
      The study design includes a screening period, a 12-week treatment period, and a follow-up
      period. Eligible patients will be randomly assigned, under double-blind conditions, to
      receive the following study drug treatments in a 1:1:1 ratio during the double-blind
      treatment period: Risperidone ISM® 75 mg, Risperidone ISM® 100 mg, or placebo. The IM study
      drug (double-blind active Risperidone ISM® or placebo) will be administered in a deltoid or
      gluteal muscle for a total of 3 times, once every 4 weeks, during the 12-week treatment
      period.

      If indicated for an individual patient, prohibited medications may be washed out during the
      screening period. Patients who have never taken Risperidone must have a brief trial of oral
      Risperidone in order to ensure a lack of any clinically significant hypersensitivity
      reactions before the first dose of the study drug is administered.

      Efficacy will be assessed by describing changes in scores on standard psychiatric assessment
      tools at each visit. Safety assessments will also be conducted at each visit.

      The primary objective of this study is the following:

      • To evaluate the efficacy of Risperidone ISM as compared with that of placebo in the
      treatment of patients with acute exacerbation of schizophrenia

      The secondary objectives of this study are the following:

        -  To characterize safety and tolerability of Risperidone ISM as compared with that of
           placebo in patients with acute exacerbation of schizophrenia

        -  To quantify healthcare resource utilization (HRU), health-related quality of life
           (HRQL), and social functioning in patients treated with Risperidone ISM versus placebo
           for an acute exacerbation of schizophrenia

        -  To explore pharmacokinetic characteristics of Risperidone ISM and associations with
           efficacy

      Patients who complete planned double-blind study drug treatments and study evaluations may be
      eligible to participate in an optional long-term extension segment of the study in which
      treatment with open-label Risperidone ISM 75 or 100 mg (randomly assigned) would begin
      immediately; for patients who do not participate in the extension segment, a safety follow-up
      phone contact will occur after the end-of-treatment visit.

      In addition to patients continuing from the double-blind segment of the study (rollover
      patients), patients not previously enrolled in the study (de novo patients) may be eligible
      to enter the long-term extension segment of the study. These patients will be evaluated for
      eligibility at a screening visit and, if eligible, will be allocated to receive either 75 or
      100 mg Risperidone ISM every 4 weeks for approximately 12 months.
    

Intervention name(s): Risperidone ISM 75 mg; Risperidone ISM 100 mg; Placebo of Risperidone ISM
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Monthly (once every 4 weeks) IM injection in the gluteal or deltoid muscle.; Monthly (once every 4 weeks) IM injection in the gluteal or deltoid muscle.; Monthly (once every 4 weeks) IM injection in the gluteal or deltoid muscle.
Other intervention name(s): Risperidone ISM; Risperidone ISM; PLACEBO
Intervention MeSH terms: Risperidone
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment