Effects of Cariprazine on Cardiac Repolarization in Patients With Schizophrenia

Forest Laboratories129 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Enrollment

129

Conditions

Schizophrenia

Interventions

CariprazineDRUG

Patients meeting all study eligibility criteria will be randomized to receive cariprazine (Group 1) 1.5 to 18 mg once daily, administered orally.

Risperidone/MoxifloxacinDRUG

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.

Risperidone/MoxifloxacinDRUG

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.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 50 Years

Medical Language ↔ Plain English

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

Locations (4)

Forest Investigative Site 001

Glendale, California, United States

Forest Investigative Site 004

Long Beach, California, United States

Forest Investigative Site 002

Willingboro, New Jersey, United States

Forest Investigative Site 003

Houston, Texas, United States

Outcomes

Primary Outcomes

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.

Time frame: 35 days of double-blind treatment, up to 56 days total.

Data from ClinicalTrials.gov

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