Effects of Cariprazine on Cardiac Repolarization in Patients With Schizophrenia

Forest Laboratories

Status and phase: Completed; Phase 1

Conditions: Schizophrenia

Treatments: Drug: Risperidone/Moxifloxacin; Drug: Cariprazine

Study type: Interventional

Funder types: Industry

Identifiers

NCT01376076

RGH-MD-02

Details and patient eligibility

About

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

Enrollment: 129 patients

Sex: All

Ages: 18 to 50 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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129 participants in 3 patient groups, including a placebo group

1

Experimental group

Description:

Sequential, Multiple Dose, titration from 1.5mg to 18mg once daily dose of cariprazine

Treatment:

Drug: Cariprazine

2A

Placebo Comparator group

Description:

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

Treatment:

Drug: Risperidone/Moxifloxacin

Drug: Risperidone/Moxifloxacin

2B

Placebo Comparator group

Description:

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

Treatment:

Drug: Risperidone/Moxifloxacin

Drug: Risperidone/Moxifloxacin