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

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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


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
sites
Fort Lauderdale, Florida 33308
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Austin, Texas 78754
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Long Beach, California 90806
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Overland Park, Kansas 66212
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Overland Park, KS
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Philadelphia, Pennsylvania 19102
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Philadelphia, PA
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Rockville, Maryland 20850
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Rockville, MD
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San Diego, California 92102
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San Diego, CA
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St. Louis, Missouri 63110
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St. Louis, MO
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