Trial to Evaluate the Effects of OPC-34712 on QT/QTc in Subjects With Schizophrenia or Schizoaffective Disorder

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

218 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-07-31

Study Completion Date

2012-03-31

Brief Summary

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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

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Detailed Description

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Conditions

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Schizophrenia Schizoaffective Disorder

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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Arm 1 (OPC-34712, placebo)

Arm 1 will be administered 4 mg OPC-34712 once daily (QD) for 11 days and OPC-34712 placebo for 1 day.

Group Type ACTIVE_COMPARATOR

OPC-34712 (4mg)

Intervention Type DRUG

Arms assigned to this intervention receive 4mg.

Placebo

Intervention Type DRUG

OPC-34712 placebo

Arm 2 (OPC-34712, placebo)

Arm 2 will be administered 12 mg OPC-34712 QD for 11 days and OPC-34712 placebo for 1 day.

Group Type ACTIVE_COMPARATOR

OPC-34712 (12mg)

Intervention Type DRUG

Arms assigned to this intervention receive 12mg.

Placebo

Intervention Type DRUG

OPC-34712 placebo

Arm 3 (moxifloxacin, placebo)

Arm 3 will be administered 400 mg moxifloxacin (positive control) plus OPC-34712 placebo for 1 day and OPC-34712 placebo QD for 11 days.

Group Type ACTIVE_COMPARATOR

Moxifloxacin

Intervention Type DRUG

Arms assigned to this intervention will receive 400mg.

Placebo

Intervention Type DRUG

OPC-34712 placebo

Arm 4 (moxifloxacin, placebo)

Arm 4 will be administered OPC-34712 placebo QD for 11 days and 400 mg moxifloxacin (positive control) plus OPC-34712 placebo for one day.

Group Type ACTIVE_COMPARATOR

Moxifloxacin

Intervention Type DRUG

Arms assigned to this intervention will receive 400mg.

Placebo

Intervention Type DRUG

OPC-34712 placebo

Interventions

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OPC-34712 (4mg)

Arms assigned to this intervention receive 4mg.

Intervention Type DRUG

Moxifloxacin

Arms assigned to this intervention will receive 400mg.

Intervention Type DRUG

OPC-34712 (12mg)

Arms assigned to this intervention receive 12mg.

Intervention Type DRUG

Placebo

OPC-34712 placebo

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No