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

Completed · Phase 1 · Has a placebo group

Conditions studied: Schizophrenia, Schizoaffective Disorder

In brief

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

Key facts

Study ID

NCT01423916

Run by

Otsuka Pharmaceutical Development & Commercialization, Inc.

People needed

218

Starts

2011-07-01

Expected to finish

2012-03-01

Last updated by the study team

2015-10-29

Who can join

Age: 18 and older, up to 55. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Otsuka Investigational Site — Long Beach, California, United States
• Otsuka Investigational Site — San Diego, California, United States
• Otsuka Investigational Site — Fort Lauderdale, Florida, United States
• Otsuka Investigational Site — Overland Park, Kansas, United States
• Otsuka Investigational Site — Rockville, Maryland, United States
• Otsuka Investigational Site — St Louis, Missouri, United States
• Otsuka Investigational Site — Philadelphia, Pennsylvania, United States
• Otsuka Investigational Site — Austin, Texas, United States

Full record on ClinicalTrials.gov

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