NCT01376076

Effects of Cariprazine on Cardiac Repolarization in Patients With Schizophrenia

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 129 (actual)
• Sponsor: Forest Laboratories · Industry
• Sex: All
• Age: 18 Years – 50 Years
• Healthy volunteers: Not accepted

Summary

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

Conditions

• Schizophrenia

Interventions

Type	Name	Description
DRUG	Cariprazine	Patients meeting all study eligibility criteria will be randomized to receive cariprazine (Group 1) 1.5 to 18 mg once daily, administered orally.
DRUG	Risperidone/Moxifloxacin	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.
DRUG	Risperidone/Moxifloxacin	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.

Timeline

• Start date: 2011-06-01
• Primary completion: 2012-02-01
• Completion: 2012-02-01
• First posted: 2011-06-20
• Last updated: 2012-02-08

Locations

4 sites across 1 country: United States