Trial to Evaluate the Effects of OPC-34712 on QT/QTc in Subjects With Schizophrenia or Schizoaffective Disorder
Status: | Completed |
---|---|
Conditions: | Schizophrenia, Psychiatric |
Therapuetic Areas: | Psychiatry / Psychology |
Healthy: | No |
Age Range: | 18 - 55 |
Updated: | 4/21/2016 |
Start Date: | July 2011 |
End Date: | March 2012 |
A Parallel-arm, Double-blind, Placebo and Positive Controlled Multiple Oral Dose Administration Trial to Evaluate the Effects of OPC-34712 on QT/QTc in Subjects With Schizophrenia or Schizoaffective Disorder
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
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
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.
We found this trial at
8
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