Conditions: Schizophrenia Schizoaffective Disorder
Keywords: Schizophrenia QTc Interval
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 218
Healthy volunteers: no

Brief 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

Detailed description:

Arms:
arm 1: Arm 1 will be administered 4 mg OPC-34712 once daily (QD) for 11 days and OPC-34712 placebo for 1 day. arm 2: Arm 2 will be administered 12 mg OPC-34712 QD for 11 days and OPC-34712 placebo for 1 day. arm 3: 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. arm 4: 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.

Interventions: intervention 1: OPC-34712 (4mg) intervention 2: Moxifloxacin intervention 3: OPC-34712 (12mg) intervention 4: Placebo
Intervention descriptions: intervention 1: Arms assigned to this intervention receive 4mg. intervention 2: Arms assigned to this intervention will receive 400mg. intervention 3: Arms assigned to this intervention receive 12mg. intervention 4: OPC-34712 placebo

Protocol document: