Trial to Evaluate the Effects of OPC-34712 on QT/QTc in Subjects With Schizophrenia or Schizoaffective Disorder
Condition: Schizophrenia; Schizoaffective Disorder
MeSH terms: Schizophrenia; Psychotic Disorders
Intervention: OPC-34712 (4mg); Moxifloxacin; OPC-34712 (12mg); Placebo
Intervention description: Arms assigned to this intervention receive 4mg.; Arms assigned to this intervention will receive 400mg.; Arms assigned to this intervention receive 12mg.; OPC-34712 placebo
Intervention MeSH terms: Moxifloxacin
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 218.0
Sex: All
Minimum age: 18 Years
Maximum age: 55 Years
Healthy volunteers: No
Keywords: Schizophrenia; QTc Interval

Summary:

      The purpose of this study is to establish pharmacodynamics (PD), pharmacokinetics (PK), and
      adverse event (AE) profile of OPC-34712 administered to schizophrenic/schizoaffective
      subjects. The goals of this trial are three-fold:

        -  To determine the effect of OPC-34712 on the individual QT interval (QTcI) corrected for
           placebo

        -  To determine the effect of moxifloxacin on QTcI

        -  To examine the concentration-effect relationship of OPC-34712 and moxifloxacin on QTcI
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male and female subjects between 18 and 55 years of age, inclusive, with a diagnosis
             of schizophrenia or schizoaffective disorder as defined by DSM-IV-TR criteria.

          -  Body mass index of 19 to 35 kg/m2.

        Exclusion Criteria:

          -  Females who are pregnant or lactating. A negative serum pregnancy test must be
             confirmed prior to the first dose of trial medication for all female subjects.

          -  Subjects presenting with a first episode of schizophrenia or schizoaffective disorder
             based on the clinical judgment of the investigator.

          -  Subjects who have received continuous medication therapy to treat schizophrenia or
             schizoaffective disorder for less than 6 months prior to washout.

          -  Subjects with schizophrenia or schizoaffective disorder that are considered
             resistant/refractory to antipsychotic treatment by history, who have a history of
             failure to clozapine, or who are responsive only to clozapine treatment.

          -  Subjects with a current DSM-IV-TR Axis I diagnosis other than schizophrenia or
             schizoaffective disorder.

          -  Hospitalization for an exacerbation of schizophrenia or schizoaffective disorder
             within 3 months prior to randomization.

          -  Subjects who have a history of or who have evidence of other medical and/or
             neurological conditions that would expose them to an undue risk of a significant AE or
             interfere with assessments of safety or efficacy during the course of the trial.

          -  Subjects with a history of neuroleptic malignant syndrome.

          -  Subjects with a history of seizure disorder.

          -  Subjects who meet DSM-IV-TR criteria for substance dependence within 6 months prior to
             randomization.