Effects of Cariprazine on Cardiac Repolarization in Patients With Schizophrenia

Phase 1

Completed

• Conditions: Schizophrenia
• Interventions: Drug: Cariprazine; Drug: Risperidone/Moxifloxacin

• Registration Number: NCT01376076
• Lead Sponsor: Forest Laboratories

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2011-06
• Study First Submitted: 2011-06-16
• Study First Submitted QC: 2011-06-17
• Study First Posted: 2011-06-20
• Status Verified: 2012-02
• Primary Completion: 2012-02
• Study Completion: 2012-02
• Last Update Submitted: 2012-02-07
• Last Update Posted: 2012-02-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 129

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	Cariprazine	Sequential, Multiple Dose, titration from 1.5mg to 18mg once daily dose of cariprazine
2A	Risperidone/Moxifloxacin	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
2B	Risperidone/Moxifloxacin	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

Primary Outcome Measures

Name	Time	Method
Heart rate-corrected QT interval (QTc)	35 days of double-blind treatment, up to 56 days total.	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.

Trial Locations

Locations (4)

Forest Investigative Site 003; 🇺🇸 Houston, Texas, United States

Forest Investigative Site 002; 🇺🇸 Willingboro, New Jersey, United States

Forest Investigative Site 004; 🇺🇸 Long Beach, California, United States

Forest Investigative Site 001; 🇺🇸 Glendale, California, United States