Effects of Cariprazine on Cardiac Repolarization in Patients With Schizophrenia

Study Overview
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Brief Summary
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This study will evaluate the effects of sequential multiple dose regimens of cariprazine on cardiac repolarization in patients with schizophrenia.

Official Title
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Evaluation of the Effects of Sequential Multiple-Dose Regimens of Cariprazine on Cardiac Repolarization in Patients With Schizophrenia

Conditions
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Schizophrenia

Intervention / Treatment
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* Drug: Cariprazine
* Drug: Risperidone/Moxifloxacin
* Drug: Risperidone/Moxifloxacin


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Men or women, age 18 to 50, inclusive Symptoms of schizophrenia or schizoaffective disorder first appearing a minimum of 1 year before screening Negative pregnancy test Normal physical examination results, vital signs, and clinical lab test results Exclusion Criteria: Axis II disorder severe enough to interfere with the study Smoking more than 20 cigarettes a day History or presence of cardiovascular disorder Pregnant/breast-feeding and/or planning to become pregnant/breast-feed Imminent risk of injuring self or others or causing significant property damage

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>Sequential, Multiple Dose, titration from 1.5mg to 18mg once daily dose of cariprazine | Drug: Cariprazine<br>* Patients meeting all study eligibility criteria will be randomized to receive cariprazine (Group 1) 1.5 to 18 mg once daily, administered orally.<br>|
| Placebo Comparator: 2A<br>Double blind placebo for Days 1-5, Moxifloxacin (400mg) on Day 6, Risperidone 4mg once daily Days 7-15, placebo Days 16-20, Risperidone Days 21-29, placebo Days 30-35 | Drug: Risperidone/Moxifloxacin<br>* Patients randomized to Group 2A will receive double blind placebo for Days 1-5, Moxifloxacin (400mg) on Day 6, Risperidone 4mg once daily Days 7-15, placebo Days 16-20, Risperidone Days 21-29, placebo Days 30-35.<br>|
| Placebo Comparator: 2B<br>Double blind placebo for Days 1-6, Risperidone 4mg once daily Days 7-15, placebo Days 16-20, Risperidone Days 21-29, placebo Days 30-34, Moxifloxacin (400mg) on Day 35 | Drug: Risperidone/Moxifloxacin<br>* Patients randomized to Group 2B will receive double blind placebo for Days 1-6, Risperidone 4mg once daily Days 7-15, placebo Days 16-20, Risperidone Days 21-29, placebo Days 30-34, Moxifloxacin (400mg) on Day 35.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Heart rate-corrected QT interval (QTc) | The effects of a therapeutic dosage (9 mg/day) and a supratherapeutic dosage (18 mg/day) of cariprazine on cardiac repolarization as determined by heart-rate-corrected QT intervals will be assessed on Day 20 and Day 34, respectively. The assay sensitivity of moxifloxacin 400 mg/day will be assessed on Day 6 and Day 35. | 35 days of double-blind treatment, up to 56 days total. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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QTc, schizophrenia, cardiac repolarization